1. At what stage of the development/manufacturing process is raw material variability the biggest concern for you and why?

Raw material variability concerns every stage of the product lifetime because distracts the efforts of not only the product characterization but also the product manufacturing stability and inventory availability due to extensive study determinations and franchise disturbances, respectively.

Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico

Raw material variability became a concern at MFG scale; this is when it was first noticed as the large quantities of raw materials utilized lead to picking up on differences in productivity that wasn't noticed at small scale. Due to this, we have made it our concern in development.

Stefanie Brady, Bioprocess Engineer, Biopharmaceutical Development, Human Genome Sciences, Inc.

2. What type of biopharmaceutical raw material has caused the most headaches - in terms of variability - for your company, and in your opinion what are the main reasons for the variability of this raw material?

Any raw material variability causes headaches due to the atypical response that is always associated with the characteristic induced by the random attribute in the material. This random attribute has been associated to not only to the supplier production but also to the raw materials used in to produce the procure material itself.

Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico

Hydrolysates!

Stefanie Brady, Bioprocess Engineer, Biopharmaceutical Development, Human Genome Sciences, Inc.

3. Can you give one example of a raw material control strategy, technology or characterization method you use that helps you to manage raw material variability?

Strategies have been as simple as just purchasing a higher quality raw material produced using higher quality standards or as complex as performing mutual material characterization studies to better understand the material composition which can later be controlled with adjusted operational and performance parameters.

Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico

Pre-screening / selection

Stefanie Brady, Bioprocess Engineer, Biopharmaceutical Development, Human Genome Sciences, Inc.

4. In the presentation you will give at IBC's Biopharmaceutical Raw Materials conference, what is the take home message you will want attendees to learn from your experiences with raw materials?

Take home message: Reduction of raw material variability is an effort that cannot be achieve without the support of the suppliers and the suppliers' of the suppliers.

Victor J. Melendez Colon, Ph.D., Principal Scientist, Process Development, Amgen Manufacturing, Limited, Puerto Rico

To consider raw material variability as one of your development variables in order to design a process that is robust enough to deal with the variability.

Stefanie Brady, Bioprocess Engineer, Biopharmaceutical Development, Human Genome Sciences, Inc.