An Interview with AltheaKristin DeFife, Ph.D.Thursday, November 29, 2012What, in your opinion, is currently the single lar...
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An Interview with Althea

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An interview with Althea's Director of Biologics, Kristin DeFife that appeared in Pharmaceutical Outsourcing. She discusses biologics trends, such as biosimilars and prefilled syringes, as well as innovative protein formualtion and delivery technologies.

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An Interview with Althea

  1. 1. An Interview with AltheaKristin DeFife, Ph.D.Thursday, November 29, 2012What, in your opinion, is currently the single largest trend with respect to biologicsmanufacturing?With numerous biopharmaceutical patents set to expire and a biosimilars approval pathway secured inthe US, the single largest trend with respect to biologics manufacturing is the growing interest inbiosimilars development. Because biosimilars do not have the same drastic cost-cutting potential astraditional generics, this trend towards biosimilars is also driving interest in the development of efficientmanufacturing and next-generation technologies. In particular, the delivery challenges faced by biologicsmay render delivery technologies even more important than price when determining a biosimilar’s value.Many biologics manufacturers have heeded the call to address the delivery challenge and create superiorproducts, as evidenced by the many innovative devices and formulation technologies being developed inthe industry. For example, Althea’s Crystalomics® technology can formulate proteins in a crystalsuspension. This formulation switches the route of administration from IV to subcutaneous, enablingpatients to self-administer and receive their therapies with much less pain and discomfort.The rise of biosimilars development is a strong and growing trend, and as this market expands,manufacturers who embrace technologies that improve the production, safety, efficacy, and delivery ofbiologics will have distinct market advantages.What are the challenges of working in biologics manufacturing?With scientists learning more about the genetic basis of diseases every day, biologics have enormoustreatment potential. However, biologic drugs have unique delivery challenges relative to small moleculedrugs. They are often prone to stability issues, and many have to be administered frequently or throughan IV infusion at a medical facility. These issues make treatment painful and cumbersome for patients,and present a considerable challenge for biologics manufacturers to solve, as partners in developmentwith their pharmaceutical and biotech clients.One solution Althea has pursued to address delivery challenges is to provide high-speed syringe filling, sothat clients can take advantage of all the benefits of switching from vials to prefilled syringes. Because

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