Whether your biopharmaceutical is a novel molecule or a biosimilar, to ensure patient safety it will require GMP lot release to validated assays before it can released to the clinic.

RSSL’s biopharmaceutical experts are able to offer validatable solutions for release testing to address the identity, purity, biosafety, concentration and potency of your molecule.

GMP release testing undertaken includes:

Looking beyond the needs of releasing your molecule, we are also able to support you with:

Monograph Testing

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 pharmacopoeial testing

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