An Interview with AltheaKristin 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

they allow drugs to be self-administered, prefilled syringes are significantly more patient friendly than

traditional vial-filled products, and considerably more cost-effective. Biologics manufacturers must

continue to implement such technologies to overcome the delivery challenge of biologics, and in so doing,

realize their full potential.

Is there a country or region of the world that is currently growing or increasing their expertise and market share in biologics manufacturing?

As the demand for biologics in emerging economies grows, these countries are rapidly increasing their

expertise and market share in biologics manufacturing, with Brazil, China, India, and Russia leading the

growth of the industry. These countries are characterized by many smaller companies, rather than a

handful of large leaders like in the U.S., creating an environment that is very exciting, fast-paced, and

inclined to innovation. The growth here is further fueled by the expanding biosimilars market, which is

particularly important in very populous countries like Brazil, India, China, and Russia that need to lower

healthcare costs. The number of collaborations between the U.S. and countries like China is already

growing, and this trend will unquestionably continue as these countries continue to expand their business

and expertise.