Biologic Quality Control & Stability

Reliable methods to test your product.

Your clinical & commercial programs will be accelerated by leveraging our expansive in-house QC capabilities, technologies, and knowledge to deliver methods tailored to your molecule.

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Our team’s commitment to quality excellence and compliance is unwavering in the realm of biopharmaceutical drug development, where precision and integrity are paramount. We are focused on accelerating your large molecule’s path –  developing, executing and documenting the phase-appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND, BLA and marketing applications.

What development stage are you at? - Abzena

End-to-end support for your program

Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies.

Our in-house analytical approach focuses on qualifying phase appropriate assays for a spectrum of testing including: safety, potency, purity, identity, and extended characterization that enable end-to-end support for:

  • Cell line development
  • Bioassays & Immunogenicity
  • Formulation development & analytics
  • Standalone analytical services
  • Process development and optimization
  • GMP manufacturing
  • Release and stability testing for GMP material
  • Regulatory support & compliance
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Our Capabilities

We provide transparent and regular communications to ensure we meet your program goals and timelines.

Titer/Productivity

  • Protein A, L, G, CH1, affinity and custom solutions​
  • Biolayer Interferometry

Purity/Identity

  • CESDS (reduced and non-reduced)​
  • SDSPAGE (reduced and non-reduced)
  • Western Blot​
  • SE-(u)HPLC
  • iCIEF/CIEF/CZE/IEX​
  • RPHPLC​
  • UV/Vis Spectroscopy​
  • Residual Protein A​
  • Residual Host Cell Protein

Potency

  • Antigen binding ELISA​
  • Biolayer Interferometry​
  • UV-Vis spectrophotometry​​
  • Cell-based potency assays

Compendial​

  • Appearance (USP<790>/EP2.9.20), (USP<631>/EP2.2.2), (USP<855>/EP2.2.1)​
  • Osmolality (USP<785>/EP2.2.85)​
  • pH (USP<791>/EP2.2.3)​

Extended Characterization Analyses​

  • Intact Mass
    • Native intact mass​
    • N-deglycosylated intact mass
  • Reduced Subunit Intact Mass​
    • Native reduced subunit intact mass
    • N-deglycosylated reduced subunit intact mass​
  • Peptide Mapping​
    • Amino acid composition
    • Oxidation, Lysine Clipping​
    • Acetylation, Sulfation, Phosphorylation​
    • Deamidation, Pyroglutamate formation
    • Glycation
  • Disulfide bond mapping​
  • Free sulfhydryl determination​
  • Glycopeptides​
    • N- and O- Linked glycan site mapping​
    • Glycan site occupancy​
  • Released N- and O-linked glycan identity and structure​
  • Quantification of Fucosylation​
  • Monosaccharide analysis​
  • Sialic acid content​
  • Glycan linkage analyses

Safety

  • Residual Ligand ELISA (Kit Based)​
  • Endotoxin (LAL), (USP85 / EP2.6.14)​
  • Sterility
  • Bioburden
  • Mycoplasma 
  • Mycoplasmastasis

Stability

Offering a full spectrum of services, we support stability studies for drug substance, drug product and in-use testing per ICH guidelines.

Stability-indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

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Quality Management Systems

Our Quality Management System (QMS) embodies our organization’s dedication to quality excellence.

Key elements include:

  • Document Control: We maintain comprehensive and accessible cGMP documentation, ensuring all procedures and records are up-to-date and meticulously managed.
  • Training and Competency Development: Continuous education keeps our teams at the forefront of best practices and regulatory requirements.
  • Audit Preparedness: Regular internal audits and readiness for customer audits demonstrate our commitment to compliance and continuous improvement.
  • Risk Management: Proactive identification and mitigation of potential risks safeguard the integrity of our processes and products.
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Regulatory Affairs

Ensuring compliance and robust regulatory strategies, we develop tailored phase-appropriate qualification, process characterization and analytical method validation strategies.

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We have developed hundreds of mammalian processes, giving us the insight and experience necessary to develop and optimize parameters that are critical for achieving a ...

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