There are a few areas of specialization that commonly are outsourced by innovator companies, including those who have their
own internal manufacturing capability. These include:
Product characterization: This usually includes highly specialized analytical techniques such as mass spectrometry, amino acid analysis and post-translational
modification analysis. Because these analytical methods usually require expensive equipment and highly skilled technicians,
many companies choose to engage the services of an external contract testing house.
Drug product fill-and-finish: This can include vial fill and lyophilization, combination products, and transdermal patches.
- Viral product production: There are several product types in development requiring specialized knowledge and expertise. Examples
include viral vaccines, gene therapies, and cell culture products comprising or made using baculoviruses, adenoviruses, or
a wide variety of other viruses. Some innovator companies choose to outsource the production of these types of product because
of constraints in their existing facility (e.g., segregation of production suites and air handling units), technical expertise,
or regulatory requirements.
Before making the decision to buy, get to know your potential CMO partner. Ask questions and be prepared to answer some too.
You should understand and then share what your expectations are for working with your chosen CMO, and you should have an understanding
of how its capabilities stack up against your internal capabilities and project requirements.
In general, those who choose to build tend to be the large pharmaceutical and biotech companies that have sturdy pipelines
and plenty of cash on hand. Smaller companies with fewer products and less cash often outsource production of their products.
But regardless of who you are, the choice to build or buy is one that could have a significant impact on your present and
future business success, and therefore should be made very carefully.
Maria Lusk is a director of client management at Eden Biodesign, a part of the Watson Group, Liverpool, UK, 919.806.4234, email@example.com
1. Langer E. Build or Buy? Strategic Choices in Biomanufacturing. 2010 BIO International Convention. Chicago, IL. 2010 May
2. Bush L. Build or Buy? Strategic Choices in Biomanufacturing. 2010 BIO International Convention. Chicago, IL. 2010 May
3. Liu C, William D. State of the bio-CMO market. Contract Pharma. 2010;12(3).
4. Hoffman M. Trends in bioprocessing. Bioprocessing and sterile manufacturing 2010 survey. Pharm Tech suppl. 2010;34(3):s4–s7.