CMOs are looking to take outsourcing to the next level in many different areas, with a focus on analytical testing, toxicity testing, and filling/finishing operations.
Outsourcing has become an important part of the biopharmaceutical industry, with many contract manufacturing organizations (CMOs) uniquely able to produce vaccines and therapeutics in fixed quantities on demand. Other reasons for outsourcing include the need to control costs/minimize in-house staff and resources, bring products to market in an efficient manner, and have no other means of fulfilling manufacturing capacity(1).
In the near future, CMOs expect to take outsourcing to the next level in many different areas, with a focus on analytical testing,
Toxicity testing and fill/finish operations. In addition to these predictions, CMOs are already transforming their operations to offer more choice and advanced services(1).
Contract and Extended Services
An example of this is how many sponsor companies are moving towards contract development and manufacturing organization (CDMO) service agreements to further improve their processes. In October 2022, Societal CDMO entered into two new contract development and manufacturing services agreements that will provide a range of analytical methods, technology transfer, formulation, manufacturing and packaging services for new therapeutics (2).
The first contract focuses on services such as analytical method development and validation, technology transfer and formulation optimization, clinical trial batch production and drug primary packaging. Meanwhile, a second contract is for Societal CDMO’s services such as formulation development, analytical method transfer and validation, and Good Manufacturing Practice (GMP) batch production and fill/finish(2).
Others are focused on expanding their CDMO services to clients outside the US. For example, Terumo Pharmaceutical Solutions will provide end-to-end services including prefilled syringe (PFS) design, molding, drug preparation, filling, assembly and final packaging of biotech drugs and small molecules (3).
In addition, these services will include services from early development to large-scale commercial production for global pharmaceutical customers, such as the assembly of PFS with equipment such as auto-injectors and needle safety devices (3).
With the changing state of CDMOs, acquisitions continue to occur for the betterment of the pharmaceutical industry as a whole (4).
CDMO Kindeva Drug Delivery acquired CDMO iPharma Labs, which focuses on inhaled drugs, in June 2022. Dry powder inhalers, soft mist inhalers, and nebulizers for small and large molecules are used in the early stages of drug development (4).
Catalent also completed the expansion of its clinical supply facility in Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China. The expansion allowed for the installation of additional refrigerated and frozen storage, including the development of secondary packaging capacity (5).
With new facilities opening, such as Thermo Fisher Scientific’s in Hangzhou, China, more companies aim to be at the forefront of advancing biologics, sterile development, manufacturing capabilities and more. In addition to offering integrated clinical and commercial API and drug product capabilities, the company also plans to offer commercial packaging and labeling capabilities in the near future (6).
The expansion of new facilities requires efforts to make new investments to better manufacture products. For example, Recipharm announced that they will be advancing their CDMO with a new high-speed prefilled syringe and cartridge filling line in one of their aseptic manufacturing facilities in Germany. The line will be fully compliant with Annex 1 and is designed to support both low-volume and high-volume projects (7).
As for trends in outsourcing strategies, the latest CPHI report predicts that the world is undergoing a major shift in outsourcing strategies, with innovators planning the entire lifecycle of a product as early as the preclinical stage (8).
A key finding in the report found that “pharmaceutical-ready” synthetic routes are planned much earlier in the development process, whereas “staged development” is considered an outdated approach, especially when dealing with accelerated pathways.Furthermore, the report mentions that innovators need to decide to use
Single end-to-end vendor or multi-vendor models, CDMOs need to reevaluate their development and marketing approaches (8).
The future of biopharmaceutical CMOs will reach multiple markets through single-use/single-use systems, advanced therapeutic/cell and gene therapy technologies, continuous bioprocessing, and other differentiated bioprocessing services to increase productivity and reduce costs(1).
1. BioPlan Associates, BioPlan 19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2022, www.bioplanassociates.com/19th.
2. Edited by PharmTech, Societal CDMO signed multiple CDMO service agreements. Press release. Medical Science and Technology Network. October 25, 2022.
3. Terumo Global. Terumo Pharmaceutical Solutions Expands CDMO Services
Global markets outside of Japan. Press release. October 31, 2022.
4. Kindwa. Kindeva Drug Delivery Acquires iPharma Labs Inc. Press Release. June 16, 2022.
5. Catalent. Catalent completes expansion of clinical supply facility in Shanghai, China. Press release. December 1, 2022.
6. Thermo Fisher Scientific. Thermo Fisher Scientific expands its global biologics and sterile manufacturing capabilities in China. Press release. December 8, 2022.
7. Compound. Recipharm strengthens prefilled syringe and cartridge offerings with new investment. Press release. October 19, 2022.
8. CPHI and Thermo Fisher. The Future of Outsourcing – Partner Selection Strategies. Press release. August 2022.
about the author
Jill Murphy is pharmaceutical technology.
Volume 47 Issue 1
When citing this article, please cite Murphy, J. The Evolution and Rise of Technology in Outsourcing. Pharmaceutical Technology 47 (1) 2023.