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. BA Sciences 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. BA Sciences 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 Sciences 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. BA Sciences 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. BA Sciences’ 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 Sciences can provide the solution.

BA Sciences 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 Sciences 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