Biopharmaceutical Product Analysis Ensuring the identification, purity, safety and quality of your biopharmaceutical product. ICH Q6B and EMA set out the regulatory guidelines for the physicochemical and structural characterisation of biopharmaceuticals, which includes a determination of the composition, physical properties and primary structure of the desired product. With the number of biopharmaceutical products due to go off patent in the next few years, the market for biosimilars is set to grow significantly. To gain regulatory approval, significant analytical data is required to confirm that the product has the appropriate quality, safety, efficacy and comparability to the originator molecule. Reading Scientific Services Ltd The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire RG6 6LA Tel: +44 (0)118 918 4076 Email: [email protected]Web: www.rssl.com
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Biopharmaceutical Product Analysis - RSSL · Biopharmaceutical Product Analysis Ensuring the identification, purity, safety and quality of your biopharmaceutical product. ICH Q6B
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Biopharmaceutical Product Analysis
Ensuring the identification, purity, safety and quality of your biopharmaceutical product.
ICH Q6B and EMA set out the regulatory guidelines for the physicochemical and structural characterisation of biopharmaceuticals, which includes a determination of the composition, physical properties and primary structure of the desired product. With the number of biopharmaceutical products due to go off patent in the next few years, the market for biosimilars is set to grow significantly. To gain regulatory approval, significant analytical data is required to confirm that the product has the appropriate quality, safety, efficacy and comparability to the originator molecule.
Reading Scientific Services Ltd
The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire RG6 6LA