MilliporeSigma

Lot Release & Stability

Monoclonal antibody (mAb) lot release and stability testing services

Before your mAb therapy reaches a patient, product safety and efficacy dictate careful study of the effects of environmental conditions – temperature, humidity, light, container interactions – on your mAb. We offer a full portfolio of lot release and stability testing services performed to GMP guidelines. While others may provide data points, we combine full data with regulatory guidance required for clinical submission.

We partner with you to develop a customized lot release program at every stage of biotherapeutic development:

  • Raw materials
  • Unprocessed bulk
  • Purified bulk (drug substance)
  • Final product (drug product)
  • mAb stability package

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Assay families that satisfy your testing needs

Physical testing: Characterizing the appearance of a mAb, for example through high accuracy (HIAC) particulate analysis, physical testing includes measurement of pH, osmolality, and concentration. Packaging integrity is also assessed within physical testing protocols, using Karl Fischer moisture analysis or dye ingress to confirm closure integrity.

Identification testing: Confirming that your mAb product is what you think it is can be accomplished via intact mass (IM) analysis, amino acid analysis, glycan profiling, and sequence mapping. Higher order structure (HOS) can also be evaluated.

Product impurity testing: The presence of impurities in your mAb product can present a serious risk and prevent regulatory approval. Techniques such as dynamic light scattering (DLS) and UHPLC ion exchange, used to check for size variants and charge variants respectively, provide essential data to support your clinical submission.

Potency/binding testing: The efficacy of your mAb hinges on its affinity for the target. Many different methods can be used to evaluate this, including Fc gamma receptor and C1q binding assays, specific measurement of target antigen affinity, and various cell-based assays such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP) to qualify mAb potency.

Microbiology testing: To ensure your mAb’s quality and safety, several tests are essential to meet regulatory requirements. These include bioburden determination, bacterial endotoxin testing, and sterility testing, all of which are necessary to confirm product integrity.

Process impurity/residual testing: Impurities generated during the mAb production process can slow a mAb’s ability to move through the regulatory approval process. Rigorous monitoring is necessary to detect detergent or surfactant left behind during manufacturing, while the presence of residual protein and DNA also requires thorough evaluation.

To discuss your lot release and stability needs and take the next step in securing the future of your biotherapy, fill out the form below.


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