The proteins we produce have applications ranging from use as bioscavengers to the production of biofuels and biosensors to potential application as medical devices, therapies and vaccines.
Data demonstrate the PERLXpress platform and recovery procedures are capable of producing proteins with:
- typical expression levels that are 10-fold higher per unit volume than insect cell culture systems, with little or no protein-specific optimization of the insect growth conditions
- proper function, folding and structure
- no detectable adventitious organisms
- no detectable allergenic carbohydrate structures
- purity routinely >98%
- protein functionality in vitro and in vivo
Chesapeake PERL has been actively taking steps toward implementing a comprehensive Quality Program. We have created a Quality Assurance (QA) department that reports directly to the president. QA has documented our path to a quality program in our Quality Plan which was approved by our senior management team further demonstrating our company-wide commitment to quality. The plan is based on FDA regulations (21 CFR 211 and 21 CFR 820) and incorporates modern industry standards such as those defined in ISO, ICH and ISPE.
Design requirements for products and processes are particularly important in modern quality systems. Starting with our whole insect larvae and recombinant baculovirus through our purification processes we have performed a thorough platform review. We use high quality materials for client projects such as those that are USP or ACS graded. Our downstream processes employ chromatographic and filtration-based separation methods that are standard in the pharmaceutical industry.
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