Proteomics - Biosimilars/Biologics Drug Characterisation Services - Brochure

Delivering immediate, independent and affordable assistance in demonstrating biosimilarity, with data packs to meet FDA and ICH guidelines (ICH Q6B). Biosimilar development begins with extensive structural and functional characterisation which underpins all further product development activities. Proteomics International operates a world leading ISO/IEC 17025:2005 accredited protein analysis laboratory, with a proven track record in characterising biosimilars. ISO 17025 is the most widely used standard for USA Federal testing laboratories and shares the same objective as Good Laboratory Practice (GLP) to assure data quality. The FDA states that the submission of a laboratory package from an ISO 17025 accredited facility will likely provide sufficient information for the purposes of their review.