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MONOCLONAL ANTIBODY ANALYTICS

MONOCLONAL ANTIBODY ANALYTICS

Analyzing Monoclonal Antibody (mAb) products can be challenging due to the size and complexity of the protein intermediates and final Drug Product. These challenges can be even more daunting when trying to manage multiple CDMOs and CROs depending on their areas of expertise. Boston Analytical has rolled out a comprehensive analytical solution that provides regulatory-tested methodologies for every aspect of characterizing the purity, potency, and identity of mAbs in a one-stop shop format.  Boston Analytical strives to provide characterization services that are tailored to your protein. Phase-appropriate qualification strategies are employed and non cGMP in-process/scale-up optimization services offerings are available.  

BA can support monoclonal and polyclonal antibodies as well as antibody fragments and bispecifics.  In addition, our expertise in small molecule analysis supports antibody-drug conjugate evaluations. See how we can help!

cGMP mAb Assays (*Qualified Platform Method in Place)

Process Development:

Full cGMP characterization is not always the solution when optimizing antibody development strategies.  Boston Analytical offers a panel of tests critical to the rapid turnaround time you need in a non-cGMP format. Common assays our clients utilize include:   

  • Size, Integrity, and Purity of antibodies via capillary electrophoresis 
  • Protein concentration via Nanodrop 
  • Impurity analysis (including residual oligonucleotides by pcr, and residual protein by ELISA) 
  • Binding by ELISA
  • Cell-based potency assays

mAb Raw Material Testing

Accurate characterization of the raw materials utilized in your monoclonal cell culture and purification processes is critical to ensuring impure material does not compromise the integrity of your intended formulation.  Boston Analytical specializes cGMP Raw Material testing through both USP and custom validated methods. Whether you need help with clinical phase or commercial release raw material testing, BA can provide the solution.

BA also has extensive experience with small molecule analysis, including identity, purity and potency testing through compendial or proprietary testing approaches.

Stability

Cold chain stability studies are paramount for stability evaluation of mRNA and LNP encapsulated Drug Product. BA has extensive -80°C and -20°C stability capacity and specialized critical assay control for cold chain products and freeze thaw evaluations.  In addition to standard stability storage in cGMP controlled environments, see below for our stability service management areas of expertise. 

BA can help you with:

  • Stability protocol development ·  
  • Commercial Release Studies  
  • Clinical Phase Stability with an emphasis on stability indicating assays 
  • Formulation Development & Optimization 
  • Stability  
  • Freeze Thaw Studies 

Monoclonal Antibody Analytics Inquiry Form

Simplify your Monoclonal Antibody Analysis process with BA’s comprehensive solution, please complete the form below: