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.

1. An Interview with Althea
Kristin DeFife, Ph.D.
Thursday, November 29, 2012
What, in your opinion, is currently the single largest trend with respect to biologics
manufacturing?
With numerous biopharmaceutical patents set to expire and a biosimilars approval pathway secured in
the US, the single largest trend with respect to biologics manufacturing is the growing interest in
biosimilars development. Because biosimilars do not have the same drastic cost-cutting potential as
traditional generics, this trend towards biosimilars is also driving interest in the development of efficient
manufacturing and next-generation technologies. In particular, the delivery challenges faced by biologics
may 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 superior
products, as evidenced by the many innovative devices and formulation technologies being developed in
the industry. For example, Althea’s Crystalomics® technology can formulate proteins in a crystal
suspension. This formulation switches the route of administration from IV to subcutaneous, enabling
patients 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 of
biologics 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 enormous
treatment potential. However, biologic drugs have unique delivery challenges relative to small molecule
drugs. They are often prone to stability issues, and many have to be administered frequently or through
an 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 development
with their pharmaceutical and biotech clients.
One solution Althea has pursued to address delivery challenges is to provide high-speed syringe filling, so
that clients can take advantage of all the benefits of switching from vials to prefilled syringes. Because