Manufacturing Considerations for Sourcing GMP Fermentation Services - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Manufacturing Considerations for Sourcing GMP Fermentation Services
The authors describe the critical aspects of an ideal fermentation services provider.


Pharmaceutical Technology


Conclusion

Large-scale GMP fermentation is a complicated undertaking and requires more than just a token commitment by a contract manufacturer. It requires a commitment to excellence at each stage of the manufacturing and supply process, a substantial investment in fermentation expertise and infrastructure, and a series of best practices across the broad spectrum of contract manufacturing support services.

The investment in expertise, equipment, process, and quality control can be daunting; certainly enough so that many companies are driven to seek outside supply for fermentation. By carefully defining project requirements, evaluating prospective suppliers on objective criteria for fermentation specifically and contract manufacturing overall, and being willing to walk away if there isn't a fit, a pharmaceutical company can rest assured it is taking the most rigorous steps possible to identify an important partner in its product supply chain.

Sheryl Henderson is the director of Plant Network Strategy Implementation at Pfizer Inc., tel. 269.833.5667, fax 269.833.9106,
Steven McWethy is the senior manager of the fermentation plant at Pfizer's Kalamazoo, Michigan, site. Keith Dixon is the director of bioprocess development at Pfizer.

*To whom all correspondence should be addressed.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here