Quality Control of Biologics and Biosimilars

GMP-certified quality control services for biologics and biosimilars according to customer specifications or relevant pharmacopeia.

Kymos Group is an EMA and FDA inspected CRO providing quality control of biological drugs and biosimilars being listed among the Top 10 global vendors of biosimilar testing services. 

Our GLP- and GMP-compliant CMC assays for biological drugs target very different clients, from global biosimilar manufacturers, bioprocessing facilities, API manufacturers and fill & finish plants to smaller innovator biotech firms. Working with biological drugs calls for an integrated orthogonal approach using multiple techniques to fully understand the analytical fingerprint of such complex molecules.

We are among the few CROs to provide characterizations of innovative biologics, biosimilarity assessments and routine batch testing and release for biological drugs. We combine an important pool of instruments, an inclusive list of prequalified methods for biological drugs and the capacity to develop customized projects for our clients.

Pharmaceutical Laboratory

SERVICES

Wide range of biological drugs:

Our success relies heavily on our experience with a wide range of biological drugs such as:

  • Innovative proteins and innovative mAbs
  • Biosimilars (proteins and mAbs)
  • Therapeutic peptides: innovative, generic and hybrid formulations
  • Hormones: GSF, FSH, LH, hCG, GCG, GLP1, GH, TSH
  • Monoclonal antibodies (mAbs)
  • Interferons, insulins and coagulation factors
  • Toxins: Natural, recombinant and innovative
  • Antibody drug conjugates (ADC)
  • Vaccines: Non-living and recombinant

  • Heparins and glycosaminoglycans: Unfractionated and Low-molecular-weight (LMWH)

Routine Quality Control of Biological Drugs

Kymos Group provides GMP-certified quality control for biological drugs and biosimilars such as raw materials, APIs, excipients, intermediates, IMPs, finished products, packaging materials, manufacturing equipment and process environment samples according to customer specifications or relevant pharmacopoeia (EP, USP, BP, JP). Non-compendial methods for biological drugs can also be transferred, validated or developed de novo.

For quality control of biological drugs purposes we work under approved quality agreements and issue GMP Certificates of Analysis (CoAs) signed by our QPs. These assays target manufacturers of biological drugs and products in need of outsourcing specific techniques, non-routine tests as well as routine batch testing and release.

  • Quality control of biological drugs and biosimilars involves multiple disciplines:

    • Identification test (IEF, IEX-HPLC, SEC, ELISA, peptide mapping, glycosylation profile ciIEF)
    • Appearance (color, clarity)
    • Assay (ELISA, SEC-HPLC, RP-HPLC) and dosage uniformity
    • Purity (CE-SDS -reduced and non-reduced, SEC-HPLC, RP-HPLC)
    • Protein Content (UV 280nm, Bradford, BCA, Lowry)
    • Dosage of excipients (HPLC)
    • Physical determinations (pH, osmolality)
    • Moisture (Karl Fisher)
    • Residual solvents (volatile organic compounds, organic volatile impurities)
    • Impurities identification (HPLC/UHPLC, LC-MS, GC-MS)
    • Process related Impurities determination (ELISA, RT-qPCR)
    • Elemental impurities (AAS, ICP/MS)
    • Nitrosamine impurities (LC-MS-MS, HS-GC-MS)
    • Particulate matter (visible and subvisible particles)
    • Extractables & Leachables
    • Enzymatic and chromogenic tests (heparins and others)
    • Determination of enzyme activity
    • Biological potency assays (CBA, ELISA, flow cytometry)
    • Extractable volume
    • Physical properties of injection devices (glide and brake force for syringes)
    • Other CMC tests with specific departments
Laboratory analytist with pipette

Characterization of New Biologics

Characterization of a biotechnological or biological product according to the ICH Q6B guideline includes determination of its physicochemical properties, biological activity, immunochemical properties, purity, and impurities using appropriate techniques to ensure safety, quality and efficacy. The number and nature of required assays is determined from the list below on a case-by-case basis:

  • General Analytical Techniques:

    A preliminary overview of the quality attributes of the molecule during initial development phases

  • Structural Analysis:

    Full molecular identification for strain selection, bioprocess and final product characterization

  • Conformational Analysis:

    Protein folding and 3D conformation determine biological activity and immunogenicity

  • Process-related Impurities:

    Other quality indicators of the purification process and also linked to safety concerns

  • Identity, Content, Protein Impurities:

    Chromatographic patterns are quality indicators of the purification process

  • Biological Activity:

    Biological tests to confirm molecule activity

Batch Testing and Batch Release of Biological Drugs

Kymos Group offers GMP-certified importation, batch testing and batch release services for biological drugs.

We have several Qualified Persons (QPs) and are certified importers and manufacturers for quality control of:

  • Human medicinal products
  • Veterinary medicinal products
  • Investigational medicinal products (IMPs)

Our capabilities include testing and releasing:

  • Sterile products
  • Non-sterile products
  • High-potency active ingredients (HAPI)
Quality Control laboratory

Services

Related services to Quality Control of Biologics and Biosimilars

nitrosamines GC-MS

Elemental, Nitrosamines & Other Impurity Testing

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vaccines and other biologics.

extractables and leachables

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Capillary Electrophoresis Beckman PA800S

Biosimilar Comparability Studies

Testing lab for biosimilar products – GMP inspected by U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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