GMP Biologics Services

Our team in Shrewsbury has over 20 years' experience offering a comprehensive range of analytical studies including reference standard characterization, stability, method development, phase-appropriate validation and release testing.


Areas of Service Offerings

Identity Content and Potency Purity and Impurities Physiochemical Properties Physical Attributes
SDS-PAGE with western blot or CE-SDS Cell-based potency assays Residual host cell proteins (HCP) pH determination Visual assessment
Isoform analysis (IEF, C-IEF) In vivo potency Size-exclusion HPLC (SEC) Osmolality determination Determination of volume in syringes and vials
Peptide map
 
Protein concentration  Cation-exchange HPLC Determination of excipient levels
Binding assays (SPR, FRET) Reverse-phase (RP) HPLC Sub-visible particulates
CE-SDS, 
C-IEF
Moisture
content

 

Analytical Services

a laboratory scientist prepares samples for download to High-performance Liquid Chromatograph Mass Spectrometry

According to current regulatory guidelines, extensive analysis is necessary to establish a well-characterized biologic or to demonstrate comparability between a biosimilar and the reference product. Due to these regulatory requirements, analytical testing plays a critical role in process development and the manufacturing of biopharmaceuticals.

Our skilled analytical chemistry staff has worked with a broad spectrum of molecules, including peptides, lipids, proteins, glycoproteins, protein conjugates, plasmids, adeno-associated viral vectors (AAV), synthetic peptides, oligonucleotides, and small molecules. Our analytical capabilities allow us to tailor a characterization plan to suit the needs of your product.

  • Mass Spectrometry
    • Intact proteins, including native LC-MS
    • Peptide mapping method development
    • AAV and VLP characterization
    • Glycosylation characterization
    • Disulfide bond characterization
    • Oligonucleotides
    • Lipids
    • Host cell proteins (HCP)


    Discover our full portfolio of mass spectrometry services.

  • Process-Related Residuals

    Ensure your product is free from:

    • Protein A
    • Polyethylamine immine (PEI)
    • Antifoams
    • IPTG
    • Antibiotics
  • Product-Related Impurities
    • N-Terminal truncations
    • Oxidation/deamidation/glycation
    • Disulfide bridge scrambling (misfolding)
    • C-Terminal heterogeneity and integrity
    • Aggregation


Biophysical Characterization

a laboratory scientist works on a panel of methods for HOS characterization

Correct higher order structure (HOS) is critical to ensuring proper functionality, activity, and stability of a biopharmaceutical product. A well-developed panel of methods for HOS characterization is an essential component of a complete product characterization program.

Our Shrewsbury, MA facility can determine the HOS of your protein with the following testing:

  • Aggregation & Sizing
    • Size-exclusion chromatography with multi-angle laser light scattering (SEC-MALLS)
    • Asymmetric-flow field-flow fractionation with multi-angle laser light scattering (AF4-MALLS)
    • Analytical ultracentrifugation (AUC)
    • Dynamic light scattering (DLS)
    • Electrophoresis via SDS PAGE and CE-SDS
    • Sub-visible particulate measurement via HIAC
  • Secondary/Tertiary Conformation
    • Circular dichroism (CD) spectropolarimetry
    • Fourier-transform infrared spectroscopy (FT-IR)
    • Intrinsic tryptophan fluorescence (ITF) spectroscopy
    • Extrinsic fluorescence via ANS dye binding
    • Disulfide linkage mapping via peptide mapping LC-MS/MS
  • Thermal Stability/Forced Degradation Transitions
    • CD thermal denaturation spectroscopy
    • Differential scanning calorimetry (DSC)
    • Intrinsic tryptophan fluorescence (ITF) spectroscopy
    • Extrinsic fluorescence ANS dye binding
    • Forced degradation panels (including applied thermal, shear-stress, F/T cycling, oxidation, and other stress parameters followed by HOS analysis)
  • Protein Binding Kinetics
    • Surface plasmon resonance (SPR) via BIACORE
    • Fluorescence polarization anisotropy (FPA)


Bioactivity and Potency Assays

Technician examining an ELISA plate

Potency testing is necessary to ensure the quality, safety, and efficacy of biopharmaceutical products, as well as the confirmation of biocomparability between an innovator and biosimilar product. Our full range of potency testing services for a variety of biologics includes both in vivo and in vitro bioassays.

  • In Vitro Bioassay Services

    Product-Specific Cell-Based Bioassays

    • Compendial bioassays for cytokine products
    • Potency testing of human growth factors through proliferation assays
    • Monoclonal antibodies tested for antibody-dependent cell cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), complement-dependent cytotoxicity (CDC), and apoptosis/programmed cell death (PCD


    Target-Specific Reporter Bioassays

    • For monoclonal antibody therapeutics that do not follow classical mechanism of action (MOA) pathways, target-specific reporter solutions are available
  • In Vivo Bioassay Services

    Our Shrewsbury facility can conduct in vivo bioassays for the purposes of showing efficacy and safety. These assays include adjuvant assessment, lot release potency, bacterial and viral challenge studies, and stability testing for a diverse range of products, including:

    • Hormone potency assays, such as FSH, FSH-LH, PMSG, and hCG (performed to either EP or USP)
    • Vaccines, including immunopotency, immunogenicity, antisera generation, and challenge studies (bacteria/viruses)
    • Neurotoxins
    • Allergens
    • Antivenoms

 

GMP Storage and Stability

a laboratory checks stability storage conditions

Stability studies are an essential part of product development and are conducted throughout a product's life cycle. They are required by several regulatory agencies. Our Shrewsbury site offers a comprehensive suite of storage conditions and the necessary testing required to meet regulatory requirements. Each program is defined by a customized stability study protocol based on your needs.

Maintaining the security and integrity of your cell banks is a priority. Our facilities take a multilayered approach to ensure the security and performance of the cell storage facility. These practices, coupled with appropriate custody documentation, ensure that your cell bank vials are maintained under controlled conditions.

  • Stability Storage Conditions
    • ICH conditions
      •      -70 °C
      •      -20 to -25 °C
      •      2 – 8 °C
      •      25 °C / 60% RH
      •      40 °C / 75% RH
    • Custom conditions
    • Dedicated storage
  • Storage of Cell Banks
    • Cell banks are stored at -70 °C or in vapor-phase liquid nitrogen in a controlled-access area
    • Cell banks are divided and stored in multiple, validated, liquid nitrogen dewars
    • Cell bank retrieval and shipment occurs only at the request of an authorized client representative