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Whether it is a novel molecule or a biosimilar, your biopharmaceutical product will require GMP lot release testing with validated assays before it can be released to the clinic, to ensure patient safety.
At RSSL, our biopharmaceutical experts can offer validatable solutions to confirm the identity, purity, biosafety, concentration and potency of your molecule for release.
Parameter: Quality, integrity
Method: Pharmacopeia
Parameter: Identity, integrity
Method: Peptide map (UV or MS)
Method: Glycan mapping, monosaccharides, eg. HPLC
Parameters: Purity, integrity
Method: SEC, DLS
Parameters: Safety, impurity
Method: HCP-ELISA, PCR or dye assay for DNA, PCR for mycoplasma
Method: Karl Fisher
Parameters: Concentration
Method: UV+ scan, AAA
Parameter: Safety
Method: Impurity dependent
Parameters: Identity, purity, integrity
Method: IEF, IEX
Method: SDS-PAGE, CE-SDS, RP-HPLC, SEC
Method: RP-HPLC, IEF, IEX, peptide mapping (UV or MS)
Methods: Pharmacopeia methods, sub-vis
Parameters: Potency, quality, concentration, identity
Method: ELISA
Parameters: Safety
Method: Bioburden, sterility, endotoxin
Many proteins and bioactive peptides, including insulins, somatropin, teriperitide, exenatide, erythropoietin, albumin, follitropin and interferon, have their own specific monographs in various pharmacopeia worldwide. RSSL's biopharmaceutical experts are able to support you with an extensive range of pharmacopoeial testing.