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.