Monoclonal antibodies (mAbs) are at the focal point of biologics development. Creative Biolabs has established a cutting-edge in vitro diagnostics (IVD) antibody development platform to offer custom antibody services covering every step of monoclonal and polyclonal development. We also offer accurate and effective solutions for researchers who are committed to developing antibodies in different formulations. Formulation chemists at Creative Biolabs help our clients to create new antibody products and innovate their existing ones. Our chemists have accumulated rich experience necessary to create high-quality custom reagents to every unique specification of our clients all over the world. Our experts will effectively formulate a high-performing and competitive antibody product.

Antibody Formulation

Antibodies may generate a variety of degradants during production, processing, and storage both in liquid and solid states. The tendency of antibodies to generate such degradants depends very much on their amino acid sequences, pI, hydrophobicity, and carbohydrate content. The antibody degradation products may have reduced activity but increased immunogenicity. The major purpose of formulating antibodies is to reduce the rate of antibody degradation to provide acceptable shelf life for shipping and storage. This can be done by choosing proper formulation conditions. It should be emphasized that one formulation excipient stabilizing a specific antibody may not be suitable for another one for the differences in their sequences. Moreover, excipients could alter the immune response by changing the presentation of the proteins, such as the spacing of epitopes. A proper formulation composition not only maximally preserves the activity of the antibody but also minimizes the potential immune response.

Custom Formulation Development Services

Custom Formulation Development Services at Creative Biolabs

Most antibodies are stored in a buffer containing preservatives, stabilizers or other excipients, such as Proclin 300, sodium azide, BSA, and glycerol, etc. Our scientists are proficient at custom formulation development for different types of antibodies, such as IgG, single-chain variable fragment (scFv), antigen-binding fragment (Fab), bispecific antibody (BsAb) and single-domain antibodies (sdAbs). After initial consultation, our scientists will begin formulating the antibodies our clients provided. They will be done on small scales and made into several trial batches to sample. Once the samples go through testing, a finalized formulation is created. We are confident that our technology will meet clients' needs from early research to commercial production.

Creative Biolabs has the necessary expertise and capabilities to evaluate each antibody, provide high-quality custom formulation development service and ensure we are preparing the most suitable formulation. If you are seeking an antibody in a different formulation, our seasoned scientists can help. For more detailed information, please feel free to contact us or directly send us an inquiry.

Reference

  1. Wang, W.; et al. Antibody structure, instability, and formulation. Journal of pharmaceutical sciences. 2007, 96(1):1-26.

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