GMP release testing of biopharmaceuticals

RSSL’s detailed biopharmaceutical analysis expertise can support your release testing needs with a comprehensive range of validatable solutions.

 

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. 

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GMP release testing services

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    Parameter: Quality, integrity 

     

    Method: Pharmacopeia

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    Parameter: Identity, integrity  

     

    Method: Peptide map (UV or MS)

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    Parameter: Quality, integrity

     

    Method: Glycan mapping, monosaccharides, eg. HPLC

  • Parameters: Purity, integrity

     

    Method: SEC, DLS

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    Parameters: Safety, impurity

     

    Method: HCP-ELISA, PCR or dye assay for DNA, PCR for mycoplasma 

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    Parameter: Quality, integrity

     

    Method: Karl Fisher

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    Parameters: Concentration

     

    Method: UV+ scan, AAA 

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    Parameter: Safety

     

    Method: Impurity dependent

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    Parameter: Quality, integrity

     

    Method: Pharmacopeia

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    Parameters: Identity, purity, integrity 

     

    Method: IEF, IEX 

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    Parameter: Quality, integrity 

     

    Method: SDS-PAGE, CE-SDS, RP-HPLC, SEC

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    Parameters: Identity, purity, integrity 

     

    Method: RP-HPLC, IEF, IEX, peptide mapping (UV or MS) 

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    Parameter: Safety

     

    Methods: Pharmacopeia methods, sub-vis

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    Parameters: Potency, quality, concentration, identity

     

    Method: ELISA

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    Parameters: Safety

     

    Method: Bioburden, sterility, endotoxin 

Additional analytical support:

 

 

 

 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 an extensive range of pharmacopoeial testing.

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