The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.
Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.
No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. Experts from Lonza answers questions about the proprietary expression platforms the company has assembled to rapidly generate high-producing cell lines for biological candidates.
The most effective way to stop the epidemic of opioid dependence is to eliminate the use of these highly addictive drugs after surgery. This was the goal of Pacira Pharmaceuticals, a specialty pharmaceutical company focused on the development of non-opioid products for postsurgical pain control, when it developed its injectable suspension, EXPAREL®.
The idea of thinking in terms of “operational excellence” is a relatively new idea for the biopharmaceutical industry. The enormous uncertainty associated with bringing a biological drug product from discovery to approval almost precludes the thought of forward-thinking in terms of what makes a quality product, especially during early-stage development. However, extensive product knowledge is gathered during early development, and crucial decisions are made in terms moving the science forward to generate the data required to meet your business objectives.
Alexion Pharmaceuticals, Inc. announced recently that researchers presented new long-term data from an ongoing, open-label extension of the pivotal Phase 3 ARISE trial of Kanuma (sebelipase alfa) in children and adults with lysosomal acid lipase deficiency (LAL-D), a genetic and progressive ultra-rare metabolic disease