Kromasil^® notes

Outsourced production – an opportunity for CMOs

Major changes are occurring in the development of new therapeutics within large pharmaceutical and biotechnology companies. These companies are becoming leaner and rely more on outsourcing, anything from analytical methods to full-scale contract production. With the change in paradigm there is a need for contract manufacturers (CMOs) to expand their services and guarantee quality work. Experience allows for contract manufacturing companies to deliver anything from robust analytical methods to purified APIs at a reasonable cost.

Specifically, the production of peptide therapeutics requires special knowledge and technology to be able to manufacture pure products. Peptides can be made using synthetic or recombinant methods. No matter which route the peptide is made there is a need for robust chromatography, typically HPLC. A company that can do both the synthesis in an efficient way as well as the purification can then provide a quality peptide at a good price. One such company in the USA is C S Bio from Menlo Park, California.

Founded in 1993, C S Bio is a growing biotechnology company that provides automated peptide synthesizers and custom peptides to the life sciences industry. Although their business began by producing high quality peptide synthesizers, their capabilities soon expanded into custom peptide production and contract manufacturing. The in house expertise and experience at C S Bio allows them to specifically focus on the contract synthesis and purification of complex peptides. "There is a need in the market for a company like C S Bio, that specializes in the production of difficult peptides, as the therapeutic peptides that are being discovered and advanced in the clinic are continually becoming more complex", says Heng Wei Chang, President of C S Bio.

Amidst the economic downturn, the peptide business is growing in the USA for C S Bio. "We continue to see the number of projects increase for custom peptide synthesis and purification" says Chang. C S Bio has embarked on a 32,000 sq ft expansion of their cGMP synthesis and purification capabilities to meet this increased demand. Within this expansion they have installed a number of new large dynamic axial compression columns all packed with Kromasil reversed phase media. Chang comments, "We feel that Kromasil gives us the best reproducibility and loadability. The Kromasil media lasts a long time allowing us to have continuous production to meet our increased demand."

We feel that Kromasil gives us the best reproducibility and loadability. The Kromasil media lasts a long time allowing us to have continuous production to meet our increased demand.

C S Bio's commitment to quality and compliance is the backbone of their cGMP facilities and systems. This has allowed them to stand out in the competitive landscape of the contract peptide market. With FDA regulations tightening, contract manufacturers must be proactive in securing a cGMP-compliant process. One way to be proactive is to seek out suppliers that provide quality raw materials. Kromasil is manufactured according to ISO 9001 guidelines and using a fully back-integrated process. The attention to quality that C S Bio pays to its production and Kromasil to its manufacturing makes this a fruitful relationship.