Technology Advances in Outsourcing Services

Outsourcing has become a crucial part of the biopharmaceutical industry, with many contract manufacturing organizations (CMOs) being the only facilities with the ability to produce vaccines and therapies in the vast volumes requested. Other reasons for outsourcing include the need to control costs/minimize internal staff and resources, getting a product out to the market in an efficient way, and having no alternative ways to complete manufacturing capabilities (1).

For the near future, CMOs are hoping to grow outsourcing to significantly higher levels in many different areas, with a focus on analytical testing,
toxicity testing, and fill/finish operations. In addition to these predictions, CMOs are already making shifts in their operations to have more options and advanced services (1).

Contracts and expanded services

An example of this is how many sponsor companies are heading toward contract development and manufacturing organization (CDMO) service agreements to further improve their processes. In October 2022, Societal CDMO entered two new contract development and manufacturing service agreements, which will provide an array of analytical method, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics (2).

The first contract focuses on services such as analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug. Meanwhile, the second contract targets on Societal CDMO’s services like formulation development, analytical method transfer and verification, and good manufacturing practice (GMP) batch manufacturing and fill/finish (2).

Other companies are focused on expanding their CDMO services for parenteral drugs to customers outside of the United States. For example, Terumo Pharmaceutical Solutions is set to offer end-to-end services with pre-filled syringes (PFS) design, molding, drug preparation, filling, assembly, and final packaging for biotech drugs and small molecules (3).

Additionally, the services would include early development stage to large-scale commercial production for global pharmaceutical customers, such as assembly of PFS with devices such as autoinjectors and needle safety devices (3).

Acquisitions

With the ever-changing state of CDMOs, acquisitions are continuing to occur for the overall better development of the pharmaceutical industry (4).

Kindeva Drug Delivery, a CDMO, acquired iPharma Labs, which is a CDMO focused on inhaled medicines, in June 2022. iPharma comes from a specialization background in inhalation formulation and the development of liquid, dry powder, and propellant-based therapies and has worked with dry powder inhalation, soft mist inhalers, and nebulizers for both small and large molecules in the earlier stages of drug development (4).

Catalent has also completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shangai, China. The expansion has allowed for installation of additional refrigerated and deep-frozen storage, including the development of secondary packaging capabilities (5).

New facilities

As new facilities begin to open, such as Thermo Fisher Scientific’s opening of a new facility in Hangzhou, China, more companies are aimed to be at the forefront of boosting biologics, sterile development, manufacturing capabilities, and more. In addition to offering integrated clinical and commercial drug substance and drug product capabilities, the company plans to feature commercial packaging and labeling capabilities in the near future (6).

The expansion of new facilities calls for an effort on new investments to better manufacture products. For example, Recipharm announced it would be advancing their CDMO with a new high-speed filling line for pre-filled syringes and cartridges at one of their sterile manufacturing facilities in Germany. The line will be fully Annex 1 compliant and designed to support both small- and large-volume projects (7).

Trends in outsourcing

As for trends in outsourcing strategies, the latest CPHI report predicts that a significant shift in outsourcing strategies is being experienced globally, with innovators planning out a product’s full lifecycle as early as the pre-clinical stage (8).

A key finding in the report found that “pharma-ready” synthetic routes are being planned much earlier in the development process, whereas “phase-appropriate development” is believed to be an outdated approach specifically when dealing with accelerated pathways. Further, the report mentioned that innovators will need to decide on using a
single end-to-end provider or a multi-provider model, and CDMOs need to reevaluate their approaches to development and marketing (8).

Through single-use/disposable systems, advanced therapeutics/cell and gene therapy technologies, continuous bioprocessing, and other differentiated bioprocessing services, the future of biopharmaceutical CMOs is set to emerge into multiple markets to increase productivity and cut costs (1).

References

1. BioPlan Associates, BioPlan’s 19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, April 2022, www.bioplanassociates.com/19th.
2. PharmTech Editors, Societal CDMO Signs Multiple CDMO Service Agreements. Press Release. PharmTech.com. October 25, 2022.
3. Terumo Global. Terumo Pharmaceutical Solutions Expands CDMO Services
Outside Japan for Global Market. Press Release. October 31, 2022.
4. Kindeva. Kindeva Drug Delivery Acquisition of 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 FisherScientific Expands its Global Biologicsand Steriles Manufacturing Capabilities in China. Press Release. December 8, 2022.
7. Recipharm. Recipharm Strengthens Pre-filled Syringe and Cartridge Offering with New Investment. Press Release. October 19, 2022.
8. CPHI and Thermo Fisher. The Future of Outsourcing- Strategies for Partner Selection. Press Release. August 2022.

About the Author

Jill Murphy is an Editor at Pharmaceutical Technology.