Due to the fact that many contract manufacturing organisations (CMOs) are the only facilities able to produce vaccines and treatments in the enormous volumes required, outsourcing has become an essential component of the biopharmaceutical business. Other justifications for outsourcing include the necessity to manage costs and limit internal people and resources, the need to promote a product effectively, and the lack of any other options for completing manufacturing capabilities.
CMOs intend to increase outsourcing in many different areas to much greater levels in the near future, with a concentration on analytical testing, toxicity testing, and fill-and-finish activities. In addition to these forecasts, CMOs are already changing their business practises to offer more choices and cutting-edge services.
Arrangements and enlarged services
In order to further enhance their procedures, many sponsor firms are turning to contract development and manufacturing organisation (CDMO) service agreements. Two new contract development and manufacturing service agreements were engaged in by Societal CDMO in October 2022. These agreements call for the provision of a range of analytical methods, technical transference, formulation, manufacturing, and packaging services for innovative treatments.
The first contract centres on services such as batch manufacturing for clinical trials, the development and validation of analytical methods, technical transfer with formulation optimization, and primary medication packaging. The second contract, meanwhile, focuses on the services provided by Societal CDMO, including formulation development, analytical method transfer and verification, good manufacturing practise (GMP) batch manufacturing, and fill/finish.
Other businesses are concentrated on extending their parenteral medication CDMO services to clients outside of the United States. Pre-filled syringes (PFS) design, moulding, drug preparation, filling, assembly, and final packaging, for instance, are just a few of the end-to-end services Terumo Pharmaceutical Solutions will provide for biotech pharmaceuticals and small molecules.
For international pharmaceutical clients, the services would also comprise the early development stage through large-scale commercial production, such as the assembly of PFS with devices like autoinjectors and needle safety devices.
Acquisitions As CDMOs’ status is always changing, transactions are still happening for the pharmaceutical industry’s overall betterment.
In June 2022, the CDMO Kindeva Drug Delivery purchased the CDMO iPharma Labs, which specialised in inhaled medications. iPharma has experience with dry powder inhalation, soft mist inhalers, as well as nebulizers for both small and large molecules in the early phases of drug development. It has a background in inhalation composition and the advancement of liquid, dry powder, and propellant-based medicines.
Additionally, Catalent has finished expanding its clinical supply facility in Shanghai, China’s Waigaoqiao Free Trade Zone (FTZ). The development of secondary packaging capabilities as well as the placement of additional refrigerated and deep-frozen storage have all been made possible by the expansion.
More businesses are aiming to be at the vanguard of boosting biologics, sterilisation innovation, production capabilities, and more as new facilities start to open, including Thermo Fisher Scientific’s establishment of a new plant in Hangzhou, China. The business also provides evidence-based clinical and commercial drug substance and drug product capabilities, and it soon hopes to add capabilities for commercial packaging and labelling.
The addition of new facilities necessitates an effort on the part of new investors to improve product manufacturing. For instance, Recipharm declared that one of their German sterile manufacturing plants would instal a new high-speed filling line for pre-filled syringes and cartridges in order to advance their CDMO. The line is planned to support both small- and large-volume applications.
Current outsourcing trends
According to the most recent CPHI research, there has been a dramatic shift in outsourcing tactics across the board, with innovators now planning out a product’s entire lifespan as early as the pre-clinical stage.
The report’s primary result was that pharma-ready synthetic routes are planned far earlier in the development process than previously thought, but phase-appropriate development is thought to be an outmoded strategy in particular when dealing with expedited pathways. The report also stated that innovators will need to determine whether to use a single end-to-end provider or a multi-provider model, and CDMOs will need to review their development and marketing strategies.
The future of biopharmaceutical CMOs is projected to emerge into many industries to boost productivity and reduce costs through single-use/disposable systems, enhanced therapeutics/cell and gene therapy innovations, continuous bioprocessing, and other specialised bioprocessing services.