Profacgen, a state-of-the-art protein service provider located in Long Island, NY, USA, recently introduced Biopharmaceutical Process and Product Related Impurities Analysis Service to meet its customers’ regulatory expectations and specifications for drug substance and drug product.
Biopharmaceutical products are synthesized by living cells, and henceforth amid the purification process the substrates for growth, host cell components and product variants must be evacuated. Product characterization methods in the biopharmaceutical sector have seen impressive advances in recent years, especially with the development of high-resolution-MS approaches. The need for advanced characterization is likewise being driven by the biosimilars market where a company developing a generic product must show to the regulators comparability to the innovator product.
With the vast base of isolation techniques and characterization technologies in Profacgen’s GLP / GMP compliant protein analysis laboratories, and underpinned by over 20 years of experience in supporting biologic drug development and bioprocessing, Profacgen offers a wide range of pharmaceutical services including biopharmaceutical product related impurities analysis. The company provides effective process related impurities analysis, and product related impurity testing in biopharmaceuticals.
Technologies for product related impurity analysis in Profacgen include: Host cell proteins (HCP), N-terminal truncations, Host cell DNA, Oxidation/deamidation (PTMs), etc. And technologies for process related impurities analysis include: IPTG, PEI, Kanamycin, Anti-foam, TFA/Acetate, etc.
“During the drug development process, unknowns often arise from impurities and degradation products that can be formed during the manufacturing process or storage of the new drug. Our newly released services can help meet all regulatory expectations and specifications for drug substance and drug product.” Commented Crystal, the chief marketing staff in Profacgen.
To know more about this service in Profacgen, please visit https://www.profacgen.com/biopharmaceutical-process-and-product-related-impurities-analysis.htm.
Profacgen provides process development and cGMP manufacturing services for biological active ingredients. We have ready access to state-of-the-art biopharmaceutical product development and manufacturing facilities and our staff scientists have demonstrable expertise in all aspects of biopharmaceutical manufacturing, from facility design and operation to the ability to provide best advice relating to product development. Preclinical Services in Profacgen include protein structure modeling, GPCR screening service, PEGylation service, cGMP complaint protein production, biosimilar testing services, etc.
Company Name: Profacgen
Contact Person: Ellen Burns
Address:45-1 Ramsey Road
State: New York
Country: United States