Outsourcing has become an important part of the biotech business because many contract manufacturing organizations (CMOs) are the only ones that can make the huge amounts of medicines and treatments that are needed. Some other reasons to outsource are to keep costs down and limit internal staff and resources, to get the word out about a product successfully, and because there aren’t any other ways to finish manufacturing.
Larger amounts of hiring are going to be done by CMOs in a lot of different areas soon, with a focus on analytical testing, toxin testing, and fill-and-finish tasks. Along with these predictions, CMOs are already changing how they do business to give customers more options and the most up-to-date services.
Making plans and providing more services
Contract development and manufacturing organization (CDMO) service deals are being used by a lot of major companies to make their processes even better. It was in October 2022 that Societal CDMO signed two new contract development and manufacturing service deals. These deals say that different testing methods, technical transfer, preparation, manufacturing, and packing services for new medicines must be provided.
The first deal covers services like making small amounts of drugs for clinical studies, creating and testing new analysis methods, transferring technology and improving formulations, and packing medicines for the first time. The second deal, on the other hand, is for the services that Societal CDMO offers. These include creating new formulations, transferring and verifying analytical methods, following good manufacturing practices (GMP) during batch production, and filling and finishing.
Other companies are focused on offering their injectable medicine CDMO services to customers outside of the United States. Terumo Pharmaceutical Solutions will handle the whole process of making biotech drugs and small molecules, including designing pre-filled syringes (PFS), molding them, preparing the drugs, filling them, putting them together, and packing them.
For pharmaceutical companies from other countries, the services would cover the early stages of research all the way through large-scale commercial production. For example, the services would include putting together PFS with autoinjectors and needle safety devices.
Even though CDMOs’ position is always changing, deals are still being made to help the pharmaceutical business as a whole.
Kindeva Drug Delivery bought the CDMO iPharma Labs in June 2022. iPharma Labs specialized in breathing medicines. In the early stages of drug research, iPharma has worked with dry powder inhalers, soft mist inhalers, and nebulizers for both small and big molecules. It has experience making medicines for breathing and making liquid, dry powder, and propellant-based drugs better.
Catalent has also finished growing its clinical supply center in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China. The increase has made it possible to add more chilled and deep-frozen store space as well as grow extra packing capabilities.
Brand-new facilities
As new factories open, more companies want to be at the forefront of improving biologics, sterilization, production, and other areas. For example, Thermo Fisher Scientific is opening a new plant in Hangzhou, China. The company also does commercial and trial drug substance and drug product work based on proof, and it wants to soon add commercial packing and labeling work as well.
With the addition of new buildings, new owners have to work to make the production of goods better. For example, Recipharm said that to improve their CDMO, one of their clean factories in Germany would add a new high-speed filling line for pre-filled needles and canisters. The line will be able to handle both low- and high-volume jobs.
Trends in outsourcing right now
The latest CPHI study shows that there has been a big change in how hiring is done across the board. Now, developers plan out the whole life cycle of a product as early as the pre-clinical stage.
The main finding of the study was that pharma-ready synthetic routes are planned much earlier in the development process than was previously thought. However, phase-appropriate development is now seen as an old-fashioned method, especially when dealing with fast paths. The study also said that creators will have to choose between a single end-to-end provider and a multi-provider model. Additionally, it said that CDMOs will have to look over their development and marketing plans.
In the future, biotech contract manufacturing organizations (CMOs) will expand into many industries to increase output and lower costs. They will do this by offering single-use or throwaway systems, new treatments like cell and gene therapy, continuous bioprocessing, and other specialized bioprocessing services.
