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Biopharmaceutical Process and Product Related Impurities Analysis

Profacgen offers a wide range of pharmaceutical services which includes biopharmaceutical product related impurities analysis.

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Biopharmaceutical Process and Product Related Impurities Analysis

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  1. Biopharmaceutical Process and Product Related Impurities Analysis Profacgen

  2. Biopharmaceutical products are synthesized by living cells, and hence during the purification process the substrates for growth, host cell components and product variants must be removed. These impurities include: • Product-related impurities: variants that differ from the desired product; • Process-related impurities: materials added to the process and cellular components.

  3. Product characterization methods in the biopharmaceutical sector have seen considerable advances in recent years, particularly with the development of high-resolution-MS approaches, for example in our ability to investigate glycosylation of antibodies. The need for advanced characterization is also being driven by the biosimilars market where a company developing a generic product must show to the regulators comparability to the innovator product.

  4. Profacgen offers a wide range of pharmaceutical services which includes biopharmaceutical product related impurities analysis. A variety of compounds added during the manufacture process of your biopharmaceutical products can appear in the final product as process- and product- related impurities. We provide you with effective process related impurities analysis, and product related impurity testing in biopharmaceuticals. As a result, we can help you to confirm the efficient removal of impurities by the downstream process and absence from the final product.

  5. We offer the following technologies for process-related impurities analysis, residual impurity testing and residual analysis in biopharmaceuticals:

  6. With the vast base of isolation techniques and characterization technologies in our GLP / GMP compliant protein analysis laboratories, underpinned by over 20 years of experience in supporting biologic drug development and bioprocessing, we offer a full spectrum of ready-to-use analytical methods for the detection and quantification of process- and product-related residuals and impurities. Profacgen can ensure that you meet all regulatory expectations and specifications for your drug substance and drug product.

  7. Thanks for watching! Contact Profacgen • Address: 45-1 Ramsey Road Shirley, NY 11967, USA • Website: https://www.profacgen.com

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