Biologics CDMO: Why You Need One

The rapidly growing market for biologics has made contract biologics development and production corporations (CDMO) more essential. The complexity inherent in the development of biologics and their mass production for sale makes it impossible for biopharmaceutical and pharmaceutical companies to perform the process in-house.

What Is a Biologics CDMO Company? 

A contract biologics development and manufacturing company (CDMO) provides medical biologics development and manufacturing services for pharmaceutical companies. They may focus solely on the development and production of biologics, or they may provide these same services for both biologics and small molecule drugs.

When a pharmaceutical firm discovers a new medical biologic, it may choose to partner with a biologics CDMO to outsource one or more steps of the development and manufacturing process.

Some biologics CDMOs focus on supporting certain parts of the development process, while full-service biologics CDMOs have the capability to handle each and every stage of drug development and manufacturing.

53Biologics offers a manufacturing structure fully customizable and adaptable to fulfill all your need in time, cost and manner

The services that a biologics CDMOs offer are: 

  • Research and development
  • Manufacturing

Biologics development and production companies offer their vast expertise from pre-formulation to clinical studies and large-scale manufacturing. For this reason, outsourcing to a CDMO is the most convenient alternative.

 The biologics market was valued at $9.93 billion in 2020 and is expected to reach $18.90 billion by 2026, with a compound annual growth rate of 11.2 percent between 2021 and 2026. 

Benefits of Working with a Biologics CDMO 

The creation of a new biologic product is a costly and time-consuming undertaking. Therefore, by partnering with a CDMO specialized in biologic, pharmaceutical companies gain the following benefits:

  • Great Expertise: CDMOs has extensive experience in the manufacture and creation of biopharmaceuticals. With researchers, chemists and experts specialized in each phase of the production process, a biologics CDMO is a valuable resource. Collaboration between a pharmaceutical company and a biologics CDMO leads to innovative solutions and a smoother production process.
  • Equipment and Manufacturing Facilities: Manufacturing biologics is complex; it requires different tools and processes. Pharmaceutical companies sometimes find that their capacities are stretched to the limit or that new equipment for a new drug involves costly investments to scale up production. Collaborating with a biologic CDMO allows pharmaceutical companies to have access to the necessary equipment and facilities without having to invest capital in acquiring or building them.
  • Scalability: Biologics CDMOs allow pharmaceutical companies to grow more strategically, as they can meet production deadlines and increased demand by adjusting production quantity as needed, easily adding a drug variation, and expanding manufacturing without the additional costs of labor and facility space.

53Biologics: An Advanced Biologics CDMO Company 

53Biologics is a CDMO with vast experience in biologics production, providing services in cell line transformation, bench storage and characterization (if required under cGMP standards), analytical development, process optimization (USP and DSP) and high quality batch production.

53Biologics is the ideal partner offering a customized level of quality from ISO9001 to ISO13485 and cGMP. Its cGMP production facility has ISO class 7 and 8 clean rooms and analytical and functional support laboratories for product quality testing. The facility includes a maximum fermentation capacity of 200L, primarily designed for microbial fermentation, but constantly growing, with plans to expand capacity up to 2,000L.

53Biologics has been recognized as a preferred partner by several pharmaceutical companies. As your partner in biologics manufacturing and development, our team is here to provide your pharmaceutical company with the support you need to achieve your goals, because your success is our success.

Learn More about Partnering with 53Biologics  

Contact us today to discuss your biologics development and/or manufacturing needs. 

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