Biopharmaceutical Contract Manufacturing: Contractor Selection by Market Segment - When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strate

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Biopharmaceutical Contract Manufacturing: Contractor Selection by Market Segment
When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.


BioPharm International Supplements


"We would consider working with an Asian contractor. The circumstances would be that there is a significant cost savings of 50% or greater with regulatory and execution risks of less than 10–20%. An Asian contractor with a proven track record and regulatory experience would be highly attractive."

"During the development phase of the projects, we prefer to work with a US or European company and have close interactions with them. For routine manufacturing, we would consider a contractor in Asia . . . When pricing is most important, we would consider going to an Asian contractor."

"The main reason we would consider working with a contractor in Asia is if they could do something faster or cheaper. They would need to demonstrate they can meet the EU and FDA regulations."

"Today, we have not established a relationship with any contractors in China or India. There would need to be something that attracted us to work in Asia, such as lower cost. We of course would need to check the quality of their work and it would have to meet GMP standards."

"We would like to work with Asian contractors. Contract manufacturing is booming in Korea, China, and Taiwan. Using Asian contractors provides a big opportunity for price reduction."

"In order for us to go to an Asia contractor there would have to be a big cost incentive. For large volume production, we may consider partnering with a contractor in Asia."

This shift in attitude is expected to continue as European and North American pharmaceutical and biotechnology companies gain more experience using biopharmaceutical contract manufacturers in other locations. Recently, the US Food and Drug Administration approved Celltrion, Inc., a South Korean contract manufacturer, for the production of Orencia, Bristol-Myers Squibb's fusion protein for treatment of rheumatoid arthritis. This is the first FDA approval of a large-scale Asian biopharmaceutical contract manufacturer for the manufacture of recombinant proteins for therapeutic use. This further highlights that the industry's attitude toward outsourcing biologics production to contractors located in other world areas is changing.

William Downey is the president of HighTech Business Decisions, San Jose, CA, 408.978.1035,


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