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September 16-19, 2013
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Formulation and Delivery Strategies for Biologics and Protein Therapeutics
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Agenda
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
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Formulation and Delivery
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:00
Registration and Coffee
8:00
Chairwoman's Opening Remarks
Susan Hershenson, Ph.D., President, Pharmaceutical Transformations LLC; former VP of R&D, Amgen and Genentech
Susan Hershenson, Ph.D., President, Pharmaceutical Transformations LLC; former VP of R&D, Amgen and Genentech
Particle Identification and Characterization for Realizing Stable, Safe and Effective Formulation
8:15
Regulatory Perspective: The Influence of Aggregation and Immunogenicity when Formulating Biologics and Protein Therapeutics
Whether during bioprocessing, shipping, storage or delivery to the patient, aggregation of protein therapeutics continues to be a quality and patient safety issue, for those aggregates - visible and nonvisible particulates - are root causes of immune responses that can have serious consequences for patients. With the recent release of FDA's guidance "Immunogenicity Assessment for Therapeutic Protein Products," this session describes expectations for product stability and stability assessment, particularly with regards to aggregates, that should be addressed during formulation development. Patient- and product-specific factors that affect immunogenicity will also be discussed.
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA (Via Remote Telephone Presentation)
Whether during bioprocessing, shipping, storage or delivery to the patient, aggregation of protein therapeutics continues to be a quality and patient safety issue, for those aggregates - visible and nonvisible particulates - are root causes of immune responses that can have serious consequences for patients. With the recent release of FDA's guidance "Immunogenicity Assessment for Therapeutic Protein Products," this session describes expectations for product stability and stability assessment, particularly with regards to aggregates, that should be addressed during formulation development. Patient- and product-specific factors that affect immunogenicity will also be discussed.
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA (Via Remote Telephone Presentation)
Unpublished Data
8:45
Case
Study
Subvisible Particles in Therapeutic Formulations: Evaluation and Characterization from Nanometer to Micrometer ScaleStudy
Subvisible particles are a critical quality attribute of therapeutic protein formulations, amongst others because of the potential influence on immunogenicity. A critical evaluation of established and emerging techniques for SVP the nm-size range (e.g. DLS, NTA, resonant mass measurements) and µm-size range (e.g. light obscuration, flow imaging microscopy, flow cytometry, electric zone sensing) is given. Applications, limitations and benefits are addressed in illustrative case-studies.
Andrea Hawe, Chief Scientific Officer, Coriolis Pharma
9:15
Immunogenic Consequences of Microparticulate Contaminants in Protein Formulations
This presentation aims to provide much desired knowledge on how best to evaluate and characterize subvisible particles, which along with being a potential quality issue, can pose patient safety issues and increase the potential for adverse events.
Ted Randolph, Ph.D., Gillespie Professor, Center for Pharmaceutical Biotechnology, Co-Director, University of Colorado, Boulder
This presentation aims to provide much desired knowledge on how best to evaluate and characterize subvisible particles, which along with being a potential quality issue, can pose patient safety issues and increase the potential for adverse events.
Ted Randolph, Ph.D., Gillespie Professor, Center for Pharmaceutical Biotechnology, Co-Director, University of Colorado, Boulder
9:45
Networking Refreshment Break
Unpublished Data
10:15
Case
Study
Characterization and Troubleshooting of Aggregation and Particulates in BiopharmaceuticalsStudy
The abstract for this talk was unavailable at press time.
Valentyn Antochshuk, Ph.D., Group Leader, Formulation Design and Process Compatibility, Merck Bioprocess Development
Unpublished Data
10:45
Particle Identification and Characterization for Realizing Stable, Safe and Effective Formulation
The abstract for this talk was unavailable at press time.
Kunal Bakshi, Senior Research Scientist, Pfizer
The abstract for this talk was unavailable at press time.
Kunal Bakshi, Senior Research Scientist, Pfizer
Unpublished Data
11:15
Particle Sizing Methods in Biopharmaceutical Development
Measuring size distributions of heterogeneous and dynamically changing particles in therapeutic and vaccine formulations is a challenging task that requires the use of multiple approaches. Examples of the application of various sizing methods, including micro-flow imaging (MFI), Nanosight, laser diffraction, flow cytometry, dynamic light scattering and colloidal sedimentation velocity (LumiSizer) will be discussed.
Harrison Davis, Scientist, Vaccine Drug Product Development, Merck Research Laboratories
Measuring size distributions of heterogeneous and dynamically changing particles in therapeutic and vaccine formulations is a challenging task that requires the use of multiple approaches. Examples of the application of various sizing methods, including micro-flow imaging (MFI), Nanosight, laser diffraction, flow cytometry, dynamic light scattering and colloidal sedimentation velocity (LumiSizer) will be discussed.
Harrison Davis, Scientist, Vaccine Drug Product Development, Merck Research Laboratories
Concurrent Technology Workshops
11:45
High-titer feed-stocks and an increasing demand for separation of MAb variants (aggregates, fragments, charge variants, etc.) call for chromatography resins with new features. The focus here is to develop strategies for post Protein A polishing of various MAb purification challenges. New polishing resins, both ion-exchange and multi-modal resins, with high resolution will be compared regarding binding/elution conditions and ability to separate MAbs from impurities. Depending on the level of impurities, different processes including one or two polishing steps will be proposed.
Mats Gruvegard, Bioprocess Project Leader, GE Healthcare Life Sciences
Speaker TBA
Current biomanufacturing processes have reached a high degree of standardization and companies are working on the basis of proven technology platforms. While this helps to set up new purification trains in short timeframes, virus clearance concepts still require a thorough optimization to address economic challenges and product related characteristics. The tool box is getting bigger with different membrane types and features, different pre - filtration methods as well as product conditioning. This presentation will focus on different ways to optimize virus filtration to end up with a most efficient step.
Anika Meyer, Product Manager Virus Clearance, Sartorius Stedim Biotech GmbH, Germany
Luncheon Presentation (Space is limited)
12:15
Sponsored by
Next-Generation Clarisolve Technology for Clarification of Recombinant Proteins from High Cell Density Mammalian Cell Culture SystemsIncreasingly high cell density, high product titer cell cultures containing mammalian cells are being used for the production of recombinant proteins. These high productivity cultures are placing a larger burden on traditional downstream clarification and purification operations due to higher product and impurity levels. EMD Millipore aims to address this challenge by developing a proprietary Clarisolve technology to improve primary and secondary direct depth filtration of pre-treated high cell density mammalian cell cultures. Novel filter media designs with a deep gradient-density to provide a wide span of pore sizes, tuned to couple with particle sizes created by polymer flocculation or low pH precipitation techniques, have resulted in single stage clarification process for pre-treated cell culture suspensions.
Nripen Singh. Ph.D., Research Scientist III, EMD Millipore
Jonathan Romero, Ph.D., Associate Director, Biogen Idec, Inc.
1:30
Chairman's Remarks
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems
Analytical Strategies for Determining Formulation Stability
Unpublished Data
1:45
Case
Study
Challenges and Considerations in Stabilizing Clinical In-Use Conditions for a Dual-Variable Domain Immunoglobulin- Case StudyStudy
The abstract for this talk was unavailable at press time.
Camellia Zamiri, Ph.D., Senior Scientist, NBE Formulation Sciences, Abbott Biotherapeutics Corp
2:15
Risk Assessment and Stability Study Design to Manage Temperature Excursions for Protein Therapeutics
This presentation explores environmental factors, equipment failure, packaging errors that result in temperature variations as well as various approaches for product quality evaluation following temperature excursion.
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems
This presentation explores environmental factors, equipment failure, packaging errors that result in temperature variations as well as various approaches for product quality evaluation following temperature excursion.
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems
Unpublished Data
2:45
Case
Study
Formulation and Delivery Approaches Through Rational Approaches to Developabilty and Manufacturability / Integrating Device Development Into Effective Formulation DevelopmentStudy
This talk outlines the integration of patient-centric design approach in effective formulation development and drug product development. This case study also looks into selection of formulation and delivery of devices for clinics.
Nishant Bhasin, Ph.D., Global Drug Product Integrator, Johnson & Johnson
3:15
Grand Opening of the Poster and Exhibit Hall with Refreshments
Sponsored by
Keynote Presentations
4:00
Chairman's Remarks
Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec
Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec
4:15
Producing High Quality, Low Cost Biotherapeutics in the Century of BiologyOver the last 30 years there have been substantial advancements in the manufacture of protein therapeutics. For example, product titers have been increased by more than four orders of magnitude using mammalian expression systems. Today we have the capability of producing metric tons of relatively low cost complex biologics; enough to meet the most demanding therapeutic markets. While some believe our advancements in this field are reaching a plateau, the century of biology will provide the knowledge and tools for even greater innovation for those willing to invest.
James Thomas, Ph.D., Vice President, Process and Product Development and WA Site Head, Amgen, Inc.
4:50
A Systems Approach to Managing Biomanufacturing Complexity - Genzyme's Allston Plant Case StudySandra Poole, Senior Vice President Biologics Operations, Genzyme
5:25
Transforming the Development of Biotechnology Drugs for the 21st Century: A CEO's Perspective from a Small Biotech CompanyIn these times of growing unmet medical need driven innovation in drug development is needed more than ever. Rapid translation of ideas into high value drugs that move rapidly from the bench to the bedside requires the perfect blending of science, medicine, policy and capital. While efficacy and safety will continue to be the key drivers of value, other factors driving healthcare impact, outcomes and cost will have to be more proactively integrated into drug discovery and drug development. The small biotech company will continue to be a critical component of the solution to these challenges.
Abbie Celniker, Ph.D., CEO, Eleven Biotherapeutic
6:00
Wine and Cheese Reception in Poster and Exhibit Hall
Sponsored by
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:30
Coffee
Technology Workshop with Light Continental Breakfast
7:30
While single-use and disposable technologies are prevalent in many areas within upstream and downstream processing, up until now there has not been a broadly applicable solution for chromatography steps. In this presentation, best practices for implementing pre-packed disposable columns in clinical manufacturing will evaluated, and a case study from a recent GMP manufacturing implementation will be presented.
Stephen Tingley, Vice President, Bioprocessing, RepliGen
8:00
Chairman's Remarks
Dean Pettit, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.
Dean Pettit, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.
Product Attribute Control (PAC): A Future Vision for Protein Process Development and Manufacturing
The development and manufacturing of biopharmaceuticals has historically been a challenging and expensive process over the lifecycle of the product. Typically, processes need to be scaled up and improved as product requirements increase, potentially leading to changes in product attributes and comparability risks that must be managed, with significant time and scientific effort required to address the issues and risks encountered on each individual project. Given the immense complexity and molecular heterogeneity of many biopharmaceuticals, it has been very difficult to maintain an exact profile of product attributes, or to know which of these attributes are clinically relevant. Scientific and technological advances have suggested that the development and manufacturing paradigm of the future could be freed from the constraints of the past, with a greater understanding of 1.) attribute criticality; 2.) the relationship of manufacturing process design/conditions to product attributes and 3.) the ability to assure reliable control of product quality for patients. This session will highlight key examples of advances in these areas, followed by an interactive discussion of the potential of these approaches to fundamentally transform process and product development for biopharmaceuticals.
Unpublished Data
8:15
Determining the Attributes of Aggregated Biotherapeutics and their Potential Biological Consequences
Marisa Joubert, Ph.D., Senior Scientist, Product Attribute, Sciences, Amgen, Inc.
Marisa Joubert, Ph.D., Senior Scientist, Product Attribute, Sciences, Amgen, Inc.
8:45
Connecting Product Attributes with Process Steps
Brian Collins, Ph.D., Director, Protein Sciences, Momenta Pharmaceuticals
Brian Collins, Ph.D., Director, Protein Sciences, Momenta Pharmaceuticals
9:15
CHOGenome.org - Infrastructure to Support the Next Generation of Development in Biopharmaceuticals
Many biopharmaceuticals are produced in Chinese hamster ovary (CHO) cells. The CHO K1 cell line is an ancestor to many production cell lines and was recently sequenced. We will discuss the aspects of the international community's efforts at developing an infrastructure to support, host, and disseminate genome-scale data related to CHO cell lines.
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Delaware Biotechnology Institute Faculty Fellow, University of Delaware
Many biopharmaceuticals are produced in Chinese hamster ovary (CHO) cells. The CHO K1 cell line is an ancestor to many production cell lines and was recently sequenced. We will discuss the aspects of the international community's efforts at developing an infrastructure to support, host, and disseminate genome-scale data related to CHO cell lines.
Kelvin H. Lee, Ph.D., Gore Professor of Chemical Engineering, Delaware Biotechnology Institute Faculty Fellow, University of Delaware
9:45
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Strategies for Achieving Stability for High-Protein Concentration Formulations
Unpublished Data
10:30
Case
Study
A Controlled Freeze/Thaw Study of a Monoclonal AntibodyStudy
Manasi Puri, Scientist, Biopharmaceutical Technologies, Biopharmaceutical Unit R&D, GSK
Unpublished Data
11:00
Developing Predictive Tools for Achieving Stable and High-Protein Concentration Formulations
A dynamic model is presented that can evaluate and predict this behavior of proteins in concentrated solutions as a function of their charge, charge distribution, and resultant interaction potential. In particular, the viscosity response to the stability of the proteins in solution is discussed as a dynamic output during the simulation. Emphasis is made for the impact of the significant difference between the effective hydrodynamic radius of the proteins and the "hard" radius. The larger effective radius is in part due to the high aspect ratio of a single mAb, but is exacerbated by weak clustering of multiple mAbs in solution. The modeling of an anisotropic charge distribution (including charge-dipole, and dipole-dipole induced interactions) is hypothesized to help explain some of the tendency towards these higher aspect ratio entities and the non-ideal rheological behavior observed in experiment.
John Tsavalas, Research Assistant Professor, Materials Science Program, University of New Hampshire
A dynamic model is presented that can evaluate and predict this behavior of proteins in concentrated solutions as a function of their charge, charge distribution, and resultant interaction potential. In particular, the viscosity response to the stability of the proteins in solution is discussed as a dynamic output during the simulation. Emphasis is made for the impact of the significant difference between the effective hydrodynamic radius of the proteins and the "hard" radius. The larger effective radius is in part due to the high aspect ratio of a single mAb, but is exacerbated by weak clustering of multiple mAbs in solution. The modeling of an anisotropic charge distribution (including charge-dipole, and dipole-dipole induced interactions) is hypothesized to help explain some of the tendency towards these higher aspect ratio entities and the non-ideal rheological behavior observed in experiment.
John Tsavalas, Research Assistant Professor, Materials Science Program, University of New Hampshire
Unpublished Data
11:30
Case
Study
Using Viscosity as a Sensitive Probe of the Stability of Protein Therapeutic FormulationsStudy
Protein solution rheology data in the biophysics literature have incompletely identified factors that govern hydrodynamics. Whereas spontaneous protein adsorption at the air/water (A/W) interface increases the apparent viscosity of surfactant-free globular protein solutions, it is demonstrated here that irreversible clusters also increase system viscosity in the zero shear limit. Solution rheology measured with double gap geometry in a stress-controlled rheometer on a surfactant-free Immunoglobulin solution demonstrated that both irreversible clusters and the A/W interface increased the apparent low shear rate viscosity. Interfacial shear rheology data showed that the A/W interface yields, i.e., shows solid-like behavior. The A/W interface contribution was smaller, yet nonnegligible, in double gap compared to cone-plate geometry. Apparent nonmonotonic composition dependence of viscosity at low shear rates due to irreversible (nonequilibrium) clusters was resolved by filtration to recover a monotonically increasing viscosity-concentration curve, as expected. Although smaller equilibrium clusters also existed, their size and effective volume fraction were unaffected by filtration, rendering their contribution to viscosity invariant. Surfactant-free antibody systems containing clusters have complex hydrodynamic response, reflecting distinct bulk and interface-adsorbed protein as well as irreversible cluster contributions. Literature models for solution viscosity lack the appropriate physics to describe the bulk shear viscosity of unstable surfactant-free antibody solutions.
Jai Pathak, Ph.D., Scientist, Drug Delivery and Device Group, MedImmune
Concurrent Technology Workshops
12:00
Chris Shields, Marketing Manager, Single Use Systems, Saint-Gobain Life Science
With an increased focus on process efficiency and quality, once considered basic cell culture processes are under further scrutiny. The presentation will outline how improved process control, automation and smart sensors can maximize efficiency while increasing quality and repeatability. Once considered basic operations such as seed train and cell banking will be examined.
Richard Ferraro, Business Leader WAVE Products Group, GE Healthcare
One of the key trends in bio-manufacturing is the move from the production of small molecule drugs to biologics and cellular therapies. In this environment, single-use technology platforms are a key enabler for increasing productivity and reducing costs. Here we discuss the benefits of disposable solutions, including novel scale-up vessels with specialized surfaces and custom media formulations.
Richard M. Eglen, Ph.D., Vice President & General Manager, Corning Life Sciences
12:30
Networking Luncheon in Poster and Exhibit Hall
1:45
Chairman's Remarks
Tim Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Analytical Strategies for Synchronized Formulation and Device Development
Unpublished Data
2:00
Case
Study
Strategies and Challenges in Formulation Development and Device Integration for BioproductsStudy
The talk explores the need for industry to develop an integrated product by taking into account formulation, container-closure and device requirements and then designing appropriate studies to understand and appropriately address risks related to the formulation/ container-closure/ device interfaces.
Nagarajan Thyagarajapuram, Senior Research Scientist, Eli Lilly
2:30
Integrating Device Development Into Effective Formulation Development
Developing a formulation without considering the container or delivery device, or visa versa, is a recipe for languishing innovation. The talk explores the need for industry to develop both at the same time, and to consider an approach that draws on a broader portfolio of delivery systems than those currently marketed. Attendees learn the value of integrating device design into earlier phases of drug product development, and allowing for interplay between the topics of device and formulation in order to present the best possible systems to patients.
Bart E. Burgess, Director, Business Development, West Pharmaceutical Services, Inc.
Developing a formulation without considering the container or delivery device, or visa versa, is a recipe for languishing innovation. The talk explores the need for industry to develop both at the same time, and to consider an approach that draws on a broader portfolio of delivery systems than those currently marketed. Attendees learn the value of integrating device design into earlier phases of drug product development, and allowing for interplay between the topics of device and formulation in order to present the best possible systems to patients.
Bart E. Burgess, Director, Business Development, West Pharmaceutical Services, Inc.
3:00
Rapid Reformulation to Improve Particle Formation and Stability
Vickie Dowling, Associate Director, Biopharmaceutical Development, KBI Biopharma
Vickie Dowling, Associate Director, Biopharmaceutical Development, KBI Biopharma
3:30
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Keynote Presentations
4:15
Chairwoman's Remarks
Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
4:25
Biologics Manufacturing in a Rapidly Changing EnvironmentThe environment for Biopharmaceutical manufacturing is rapidly changing. While the overall market is still growing rapidly, challenges in development coupled with increasing yields have resulted in significant overcapacity in manufacturing. At the same time disposable manufacturing approaches have made significant advances, while new biologics entering the market have seen slow adoption due to pricing/reimbursement issues and conservative prescribing by physicians. Dr. Moesta will discuss Bristol-Myers Squibb's portfolio of Biologics and the positioning of its manufacturing network in this dynamic environment.
Peter Moesta, Ph.D., Senior Vice President, Biologics Manufacturing & Process Development, Bristol-Myers Squibb Co.
5:05
Eliminating Interfaces: Process Development Lessons from Aggressive Platform DevelopmentPlatform approaches have yielded dramatic gains in speed and savings in the business of process development, most notably for antibody products. And it doesn't end there: increasingly we see platforms driving change in the organizational and scientific domain, up to and including a re-definition of the role of the process scientist itself. But how marry the core drivers of platform success - standardization and templating - with the needs of tomorrow's increasingly diverse pipelines?
Lars Pampel, Ph.D., Group Head, Early Phase Process Development, Novartis Pharma AG, Switzerland
5:05
Eliminating Interfaces: Process Development Lessons from Aggressive Platform Development
Platform approaches have yielded dramatic gains in speed and savings in the business of process development, most notably for antibody products. And it doesn't end there: increasingly we see platforms driving change in the organizational and scientific domain, up to and including a re-definition of the role of the process scientist itself. But how marry the core drivers of platform success - standardization and templating - with the needs of tomorrow's increasingly diverse pipelines?
Lars Pampel, Ph.D., Group Head, Early Phase Process Development, Novartis Pharma AG, Switzerland
Platform approaches have yielded dramatic gains in speed and savings in the business of process development, most notably for antibody products. And it doesn't end there: increasingly we see platforms driving change in the organizational and scientific domain, up to and including a re-definition of the role of the process scientist itself. But how marry the core drivers of platform success - standardization and templating - with the needs of tomorrow's increasingly diverse pipelines?
Lars Pampel, Ph.D., Group Head, Early Phase Process Development, Novartis Pharma AG, Switzerland
5:45
Wine and Cheese Reception in Poster and Exhibit Hall
Co-Sponsored by
Symposia: Monday | Courses | Main Conference: Tuesday | Wednesday | Thursday
7:30
Coffee
8:00
Chairman's Remarks
Danny K. Chou, Pharm.D., Ph.D., Senior Research Scientist I, Gilead Sciences, Inc.
Danny K. Chou, Pharm.D., Ph.D., Senior Research Scientist I, Gilead Sciences, Inc.
Strategies for Achieving Stability for High-Protein Concentration
Unpublished Data
8:15
Case
Study
Formulation and Delivery Through Rational Approaches to Developabilty and ManufacturabilityStudy
This presentation delves into rational approaches developing strategies to characterize proteins and predict stability from formulation to bioprocessing. This talk describes a new strategic approach for developability based on applying both molecular and macroscopic modeling tools in order to gain an understanding of degradation processes with unprecedented detail and accuracy. Additionally, for aggregation, spatial-aggregation propensity and developability index, algorithms can be applied in the discovery phase through the development phase to identify problems early using related tools for oxidation, deamidation, viscosity, crystalizability and hydrolysis.
Bernhardt L. Trout, Professor, Department of Chemical Engineering, Massachusetts Institute of Technology
Unpublished Data
8:45
Case
Study
Formulation Development Challenges with Highly Concentrated Protein FormulationsStudy
The abstract for this talk was unavailable at press time.
Farooq Qureshi Ph.D., Pharmaceutical and Analytical Research & Development, Hoffmann-La Roche Inc.
9:15
The biopharmaceutical industry is moving at an increasingly rapid pace to identify, develop and commercialize protein therapeutics to meet the demand for new and novel molecules to combat human diseases and conditions. This research activity is producing a large and diverse collection of API's that present challenges for the rapid transition from initial point-of-concept activities through clinical studies and then on to commercialization. One major hurdle is the rapid development of a formulation for these protein molecules, usually at higher concentrations, and in a manner that is compatible with the stage of a program (early versus late phase). Traditionally, formulation development is performed in a tiered approach examining buffers, pH, excipients, excipient combinations, solubility, stability, etc. over a timeframe of 6-9 months. There is a need to accelerate this process to gain efficiencies in the overall product development trajectory. A fast-track approach to formulation development involves leveraging formulation experience and published data for similar protein molecules (i.e. monoclonal antibodies, interleukins, enzymes, etc.) and using this data to design more targeted and combined experiments to achieve the same endpoint, a stable formulation, in fewer steps and in a shorter timeframe. In this presentation, data from both traditional and fast-track formulation development approaches will be presented and compared.
Katherine E. Bowers, Ph.D., Associate Principal Scientist, Analytical and Formulation Development, FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Unpublished Data
9:45
Case
Study
Effects of Methionine Oxidation on Conformational and Colloidal Stability of a Fusion Protein and Their Role in AggregationStudy
Physical and chemical degradation of therapeutic proteins can occur simultaneously. In this study, the first objective was to investigate how solution conditions that impact conformational stability of albinterferon alfa-2b, a recombinant fusion protein, modulate rates of methionine (Met) oxidation. Another objective of this work was to determine whether oxidation affects conformation and rate of aggregation of the protein. The protein was subjected to oxidation in solutions of varying pH, ionic strength, and excipients by the addition of 0.02% tertiary-butyl hydroperoxide (TBHP). The rate of formation of Met-sulfoxide species was monitored by reversed-phase high-performance liquid chromatography and compared across solution conditions. Albinterferon alfa-2b exhibited susceptibility to Met oxidation during exposure to TBHP that was highly dependent on solution parameters, but there was not a clear correlation between oxidation rate and protein conformational stability. Met oxidation resulted in significant perturbation of both secondary and tertiary structure of albinterferon alfa-2b as shown by both far-ultraviolet (UV) and near-UV circular dichroism. Moreover, oxidation of the protein caused a noticeable reduction in the protein's resistance to thermal denaturation. Surprisingly, despite its negative effect on solution structure and conformational stability, oxidation actually reduced the protein's aggregation rate during agitation at room temperature as well as during quiescent incubation at 40°C. Oxidation of the protein resulted in improved colloidal stability of the protein, which is manifested by a more positive B(22) value in the oxidized protein. Thus, the reduced aggregation rate after oxidation suggests that increased colloidal stability of oxidized albinterferon alfa-2b counteracted oxidation-induced decreases in conformational stability.
Danny K. Chou, Pharm.D., Ph.D., Senior Research Scientist I, Gilead Sciences, Inc.
10:15
Networking Refreshment Break in Poster and Exhibit Hall
Sponsored by
Biosimilar Formulation and QbD Considerations for Biologic Development
Unpublished Data
11:00
How Quality by Design (QbD) and Process Analytical Technology (PAT) Can Improve Structure-Activity Relationship (SAR) Evaluation and Its Relevance to Comparability Protocols and Biosimilars
This presentation provides an overview of not only how the FDA guidance can work for industry, but also drug makers can apply it to develop novel strategies to make the most of using biosimilars in protein therapeutic formulation. This talk also explore industry perspectives on the development, characterization, and manufacture of novel protein products versus biosimilars.
Robert L. Zeid, Principal Consultant, TLI Development
This presentation provides an overview of not only how the FDA guidance can work for industry, but also drug makers can apply it to develop novel strategies to make the most of using biosimilars in protein therapeutic formulation. This talk also explore industry perspectives on the development, characterization, and manufacture of novel protein products versus biosimilars.
Robert L. Zeid, Principal Consultant, TLI Development
11:30
QbD Impact on Formulation and Device Development and Manufacturing, and on Delivery of Drugs to Patients
Although the topic of QbD for biologics has been around for a number of years, no product has been approved with a design space to date. This has led to speculation that QbD may be difficult to bring to practical implementation. This talk presents benefits of QbD already be seen in the industry as well as QbD implementation to date.
Sheryl Martin-Moe, Ph.D., Vice President, Enterprise Catalyst Group
Although the topic of QbD for biologics has been around for a number of years, no product has been approved with a design space to date. This has led to speculation that QbD may be difficult to bring to practical implementation. This talk presents benefits of QbD already be seen in the industry as well as QbD implementation to date.
Sheryl Martin-Moe, Ph.D., Vice President, Enterprise Catalyst Group
Concurrent Technology Workshops
12:00
This session will focus on downstream applications for the Emphaze™ Hybrid Purifier , a new bioprocess purification platform that integrates anion exchange hydrogel chromatography and size exclusion membrane into a single-use, scalable device format.
Michael Wang, Ph.D., Advanced Technical Specialist, 3M Purification Inc.
Challenges in cell line development include: how to explore sufficient cell lines to identify clones with optimal protein expression; how to perform Design of Experiment (DoE) analyses with suitable power to identify relevant culture parameters; and how to explore more cell line candidates and culture conditions to enable better, faster decision making. This session is an overview of TAP Biosystems' advanced microbioreactor (ambr™) technology, with industry derived data that demonstrate ambr's suitability for cell culture optimization, in the context of biotherapeutics development.
Barney Zoro, Product Manager, TAP Biosystems, United Kingdom
Protein A affinity chromatography continues to be the workhorse in the purification of therapeutic monoclonal antibodies (mAb). The highly specific interaction between Protein A and an antibody's Fc region provides high product yield while also ensuring that more than 99% of impurities from clarified cell culture are removed. EMD Millipore introduces a novel Protein A chromatography resin that delivers high performance stability under extreme pH conditions. Additionally, this new resin is distinct from current commercially available Protein A resins in its unique ability to remove high molecular weight (HMW) species from a mAb feed. The added benefits of this new resin are delivered along with the high dynamic binding capacity and impurity removal capabilities expected from a modern Protein A resin.
Nanying Bian, Ph.D., EMD Millipore
12:30
Networking Luncheon and Last Chance for Exhibit and Poster Viewing in Poster and Exhibit Hall
1:40
Chairwoman's Remarks
Andrea Leone-Bay, Ph.D., Vice President of Pharmaceutical Research and Development, MannKind
Andrea Leone-Bay, Ph.D., Vice President of Pharmaceutical Research and Development, MannKind
Unpublished Data
1:45
Case
Study
Drug Product Development Strategies for BiosimilarsStudy
Drug product formulation & process development strategy for biosimilars needs to be risk-based and needs to align with scientific considerations for demonstrating biosimilarity and principles of Quality by Design (QbD). QbD based approach relating to pharmaceutical development of biosimilar products will be discussed using a case-study of one of the biosimilar pipeline molecules.
Krishnan Sampath, Ph.D., Associate Director, Formulation and Drug Product Process Development, Global Biologics R&D, Hospira
Localized and Targeted Delivery Strategies
Unpublished Data
2:15
Case
Study
Dry Powder Formulations for the Inhalation of BiologicsStudy
This presentation provides an overview of a technology platform that makes the development of dry powder biologics formulations, including peptides and proteins, and deliverable by oral inhalation. The presentation demonstrates novel platforms for diabetes, osteoporosis and pain. Dry powder formulations coupled with simple devices have been developed for the oral inhalation delivery of protein and peptide therapeutics. For these products, the formulations and the devices are intrinsically linked and product development challenges can be simplified when these efforts are combined at an early stage. This presentation demonstrates inhaled peptide/device combinations products in therapeutics areas including diabetes, osteoporosis, and pain
Andrea Leone-Bay, Ph.D., Vice President of Pharmaceutical Research and Development, MannKind
Unpublished Data
2:45
Formulation Considerations for Microneedle Delivery Systems
The abstract for this talk was unavailable at press time.
Peter R. Johnson, Research Specialist - MTS Technology and Product Development, 3M Drug Delivery Systems
The abstract for this talk was unavailable at press time.
Peter R. Johnson, Research Specialist - MTS Technology and Product Development, 3M Drug Delivery Systems
3:15
Networking Refreshment Break
Unpublished Data
3:45
General Strategies for Container Closure and Injection Devices
Strategies and approaches are discussed for qualifying primary packaging and injection devices. The risks associated with use of primary packaging and injection devices are analyzed. Studies were conducted to evaluate the performance of container closure systems and the devices. Attendee will learn strategies for qualifying primary packaging and injection devices and gain awareness of the risks associated with use of primary packaging and injection devices.
Xinghang Ma, Ph.D., Head of Formulation, Freeze-drying, and Drug Delivery, Global Biological Development, Bayer HealthCare LLC.
Strategies and approaches are discussed for qualifying primary packaging and injection devices. The risks associated with use of primary packaging and injection devices are analyzed. Studies were conducted to evaluate the performance of container closure systems and the devices. Attendee will learn strategies for qualifying primary packaging and injection devices and gain awareness of the risks associated with use of primary packaging and injection devices.
Xinghang Ma, Ph.D., Head of Formulation, Freeze-drying, and Drug Delivery, Global Biological Development, Bayer HealthCare LLC.
Unpublished Data
4:15
Case
Study
Spray-dried Powders of Anti-IgE Monoclonal Antibodies (mAb) for InhalationStudy
The study demonstrates a method of formulating room-temperature stable mAb powders for inhalation via spray drying. It utilizes spray-drying a single-phase aqueous feed stock comprising a mAb and excipients that function as dispersibility-enhancing agents or glass-forming agents. The results demonstrate highly fluidizable and dispersible mAb powders can be formulated; and stability data indicate that these dry powders have sufficient stability for up to six weeks at 40C and likely would have long-term physiochemical stability under pharmaceutically relevant storage conditions.
Sajeevi Gunasekera, Senior Scientist, Novartis Pharmaceuticals Corporation
Unpublished Data
4:45
Innovations in Large-Volume Injections for Biologics and Protein Therapeutics
The abstract for this talk was unavailable at press time.
Jennifer Laurence, Ph.D., Professor, University of Kansas
The abstract for this talk was unavailable at press time.
Jennifer Laurence, Ph.D., Professor, University of Kansas
5:15
Close of BioProcess International™ Conference & Exhibition 2013
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