Chairman's Opening Remarks Mark Plavsic, Ph.D., Head, Global Product Biosafety, Genzyme, a Sanofi Company
Lifecycle Management of Processes for the Production of Biopharmaceuticals for the Treatment of Rare Diseases Joanne T. Beck, Ph.D., Vice President, Process Development and Manufacturing Science, Shire
Viral Contamination in Large-scale Animal Cell Culture: Lessons Learned over 30 Years Matthew Croughan, Ph.D., Industry Professor, Amgen Bioprocessing Center and Founding Professor, Bioprocessing Program, Keck Graduate Institute
Networking Refreshment Break and Opening of the Poster and Exhibit Hall
Chairwoman's Remarks Fi Alonso-Caplen, Ph.D., Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
FDA's CMO Guidance, Technology Transfer and Externalization Strategies
The New FDA Guidance on Contract Manufacturing and How it Will Affect You in Your Management of CMOs In May, 2013, FDA issued their long awaited guidance "Contract Manufacturing Arrangements for Drugs: Quality Agreements". In the document, it spells out not only the elements of what and how but also the why it is important to document the arrangements between the two business parties involved. Many in the industry have been using Quality Agreements for decades, but it will be new to some. A good Quality Agreement should be driven by your business needs and serve you in cementing a working relationship. In this presentation, we will cover what they say and also what they mean by the elements described. I will also illustrate how a good Quality Agreement can aid in your relationships with CMOs. Peter H. Calcott, President, Calcott Consulting LLC (Listen to speaker interview)
Externalization Strategies for ADC Manufacture and Control This presentation will discuss: 1) Strategizing the best outsourcing practices for producing and testing ADCs for use in clinical trials; 2) Establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer; 3) Gaining insights into the complex technology transfer process for ADC manufacture and analytical control. Fi Alonso-Caplen, Ph.D., Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
Contrasting Analytical Technology Transfer Strategies for Internal vs. External Technology Transfers Heidi Kenty, Senior Product Manager, Technology Transfer, AstraZeneca Biologics
Fine Tuning Viral Clearance Approaches: Enhancing Robust Steps and Defining the Limits Attaining higher log reduction values for viral clearance validations is becoming more readily achievable with the newer, purer, and more concentrated virus preparations. Ultra-pure viruses provide significant opportunities to enhance LRVs in the more commonly validated process steps, but challenges also exist. Setting parameters to define the limits for parvovirus-removal filters, low pH inactivation, and other steps will be described for a number of viruses. Joseph V. Hughes, Ph.D., Chief Scientist, Virology & Vice President, Biopharmaceutical Services, Wuxi Apptec
Efficient and Intelligent Process Control for Cell Culture Bioprocessing operations in manufacturing, research and early development stages are increasingly reliant on robustness and predictability. Advanced instruments, software and control strategies are employed to characterized the process and its outcome for creating a defined design space and generating a strong scientific dataset. This talk presents examples of how a single-use rocking bioreactor with innovative measurement and control features can be easily operated for achieving a reliable and predictable process outcome. Richard John Ferraro, Business Leader WAVE Products, GE Healthcare
Surface Plasmon Resonance and Differential Scanning Calorimetry for Analysis of Critical Quality Attributes in Bio Therapeutic Medicines This workshop will focus on: (1)Use of SPR and DSC for analysis of binding activity and HOS; (2)a method for assessing similarity of complex binding data directly from curve shapes; and, (3) case studies, including the use of specific epitope characterizing reagents for detection of stress induced changes in the higher order structure of an antibody. Robert Karlsson, Staff Scientist, Bio-Analysis Systems R&D, GE Healthcare Life Sciences
The Challenge of Implementing L3 facilities: The Case Study of a Whole Inactivated Viral Vaccine Novasep recently decided to extend their capacities regarding Biosafety Level 3 pathogens manufacturing. With a recent project aiming to produce a whole inactivated viral vaccine, this presentation will describe the implementation of a L3 R&D laboratory and cGMP facility to streamline operations from process development to production of clinical trial batch materials. The presentation will deal with lessons that can be learned from this experience and what strategies have been employed to succeed. Francis Dupont, Ph.D., Technology Deputy Director, Novasep, Belgium
Business Implications of Statistical Methods in Stage 2 of Process Validation The statistical method used to determine the number of PPQ batches and assess process capability can have significant business implication. In this workshop, two approaches are shown using example data from Stage 1, BLA, and PPQ batches. The advantages of the Bayesian method, which provides stronger quality assurance statements about future batches, derived from fewer PPQ batches, are discussed. Tara Scherder, MSc MBB, Managing Director, Arlenda, Inc
Networking Luncheon in Poster and Exhibit Hall
Chairwoman's Remarks Patricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc.
New Models for Increasing Efficiency in Outsourcing and Technology Transfer
Moving From Outsourcing To Partnersourcing: Case Study of an End-to-end Drug Substance and Drug Product Manufacturing Collaboration Today, outsourcing is commonplace in the biopharmaceutical industry as a means of increasing operational efficiency. So what's next? Answer: increasing outsourcing efficiency. In an experiment designed to improve outsourcing efficiency, a major biopharmaceutical company recently tested the viability of utilizing a single CMO and location for an entire production campaign from process development through final product packaging. This session will present the results from this experiment, as well as what challenges and advantages were seen along the way, from both biopharmaceutical and CMO perspectives. The session will conclude with some best practice recommendations for utilizing a fully integrated CMO approach to bring additional efficiency into biopharmaceutical manufacturing. Sonia Kansal, Ph.D., Senior Manager, Biotherapeutics & Vaccines Outsourcing, Pfizer Frank Marchesani, Business Development Executive, Cook Pharmica LLC
A New Biobetter Therapeutic - Development and Manufacturing: A Collaboration Case Study Activated Protein C (APC) is a naturally occurring human protease that has both anticoagulant and cytoprotective activities, with the latter being appropriate for treatment of ischemic stroke. ZZ Biotech has created a variant, 3K3A-APC, which reduces the anticoagulant activity while retaining its cytoprotective activity, thereby avoiding the dose-limiting side effect of unwanted bleeding. We describe the development of recombinant CHO-cell production and purification of 3K3A-APC, from small cultures to 2000-liter production. By working collaboratively, scientists from both companies were able to overcome this molecule's challenges of complex post-translational modifications, enzyme isomers, and autodigestion. The result was a successful regulatory filing leading to a Phase 1 clinical trial, which recently completed. Michiel E. Ultee, Ph.D., Chief Scientific Officer, Gallus Biopharmaceuticals, LLC (Listen to speaker interview) Kent E. Pryor, Ph.D., Chief Operating Officer, ZZ Biotech
Networking Refreshment Break in Poster and Exhibit Hall
Technology Transfer Strategies and Lessons Learned
Technology Transfer of Novel Immunotherapy Program: GVAX and CRS-207 Aduro BioTech is developing novel and complex immunotherapeutics for the treatment of oncology and infectious disease indications. This talk will describe a case study for the selection of CMOs and technology transfer for Aduro's lead clinical immunotherapy, which combines GVAX, a GM-CSF expressing tumor cell line and CRS-207, a live attenuated double deleted Listeria strain, in preparation for pivotal clinical trials. We will describe the initial gap assessment process, CMO selection process and how the gap assessment was used to prioritize the technology transfer activities to ensure the knowledge and experience gained during development and early clinical manufacturing is effectively transferred. We will conclude with lessons learned from the entire process. Patricia Seymour, Senior Consultant, BioProcess Technology Consultants, Inc. Justin Skoble, Ph.D., Director, Biodefense and Process Development, Aduro BioTech, Inc.
Lessons Learned Experienced during Back to Back (to Back) Technical Transfers to an International Biotechnology Manufacturing Facility Leading a Technical Transfer for an early clinical phase program into a newly operational International Biotechnology Manufacturing Facility encompasses multiple challenges. While execution of a single program to an International Facility is difficult, implementation of multiple sequential programs with overlapping Technical Transfer activities requires a monumental effort. An overview of lessons learned experienced with overlapping Technical Transfer activities will be presented. Vincent Lau, Senior Supervisor, Cell Culture Development, Biogen Idec
Strategies to Mitigate Tech Transfer and Clinical Manufacturing Risks - Downstream Purification Case Study Yun Bai, Ph.D., Associate Director, Process Development, Ambrx, Inc.
"Mardi Gras" Networking Cocktail Reception in Poster and Exhibit Hall
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