Outsourcing can help mitigate risk and accelerate time-to-market for new products, which is critical in an industry where competition is fierce and time is of the essence. By partnering with a contract development and manufacturing organization (CDMO), biopharmaceutical companies can gain access to specialized expertise, advanced technologies and state-of-the-art facilities that may be too expensive or difficult to build in-house.
For the March 2023 edition of MJH Life Sciences Media (Pharmaceutical Technology& BioPharm International), our Chief Technology Officer Kasper Møller outlined key trends in outsourcing for 2023. Below are a few of the important takeaways from Kasper's interview.
The biggest thing researchers should keep in mind when developing a drug for clinical trials
Robustness of the manufacturing process and analytical methods can often be neglected in the early part of development to reduce costs and increase speed. AGC Biologics advises researchers and drug developers that they must consider manufacturability early in the process development phase. Too often the manufacturing process is purely lab focused without considerations for manufacturability when a product is being transferred for scale-up.
The importance of flexibility in outsourcing partnership agreements
Flexibility in outsourcing technology or companies that manage projects is something Kasper noted was very important. But potentially even more important is flexibility in manufacturing agreements.
We often see customers that have a high need for capacity, but the timing for the project is uncertain. In this instance, we have developed a best practice of being flexible with our manufacturing agreements. We offer a dedicated manufacturing line, a partially dedicated line or a line purely based on a rolling forecast where products can be exchanged, and manufacturing slots moved via a forecasting mechanism (similar to commercial manufacturing).
The products with the biggest potential in 2023 and beyond
Even as new types of biologics are becoming more prevalent, protein therapeutics and mAbs, in particular, will continue to be the top large molecule drug product for many years to come. AGC Biologics will continue to invest in this critical drug molecule type to support our customers. These investments include key activities like the acquisition of our commercial-grade large-scale 20,000 L mammalian protein manufacturing facility in Boulder (Colorado, USA), and the expansion and new building at our facility in Copenhagen (doubling our single-use capacity in Europe).
The rise in demand for Cell and Gene Therapy (CGT) capacity is also of note, as more products than ever are preparing to reach important milestones. North America has historically been the most active for new cell and gene products. But, pipeline growth in Europe and Asia for advanced therapies has shown it is a true global field. The need for end-to-end global services for plasmids, viral vectors and cell therapies is becoming essential. Developers must also look for outsourcing partners with historical scientific expertise in this relatively new field.
AGC Biologics established new global CGT services by acquiring MolMed (Milan, Italy) in 2020, where our core team of scientists has been working together for 30 years, including bringing three commercial products to market using Viral Vector production and Cell Therapy manufacturing. We also acquired our Longmont Site (Colorado, USA) to offer viral vector and cell therapy production and manufacturing capabilities in North America This site’s core team worked together when the location was owned by Novartis, and we retained so many scientific experts in this space after we purchased the Longmont campus. As a global outsourcing partner, we are prepared for this burgeoning new market.