This article explores the pivotal role of recombinant antibody technology in the biopharmaceutical industry, highlighting its impact on past successes and future innovations.
Sponsored Content by Sino Biological Inc.Reviewed by Maria OsipovaJul 8 2024 Recombinant antibody technology has been leveraged to mitigate a range of common problems associated with hybridoma platforms, helping to facilitate the development of an entirely new class of biologic drugs.
This process is also extremely time-consuming, often taking several months from initial immunization to establishing specific hybridoma clones and the resulting mAb production.1,2 For example, it is possible to modify the fragment crystallizable region to prevent the initiation of any undesired responses, while tiny variable regions can also be designed to bind to the target more effectively.6 Antibodies initially discovered in mice or other animals can then be humanized to reduce any potential immunogenicity.
Platform processes are also available, enabling the rapid upscaling of recombinant antibody production to meet rising clinical and commercial demand. It is important to note, however, that antibody fragments retain the targeting specificity of intact mAbs and exhibit properties that make them ideal for use in a range of therapeutic and diagnostic applications.
Several factors should be carefully considered when working with antibody fragments, including the implementation of appropriate design strategies, the use of upstream production processes to ensure high productivity while suppressing the generation of impurities, and the nature of any downstream processing requirements needed to produce the desired fragment in a sufficiently pure form.9
The unlocked potential of recombinant antibodies There is great interest in the therapeutic possibilities offered by cell and gene therapies and other novel modalities. However, it is also recognized that recombinant antibodies still offer significant development potential. Upcoming innovations in targets and modifications It is anticipated that the recombinant antibody sector will continue to increase in size and scope to include novel targets and modifications. As the field develops deeper insight into genomic and proteomic changes in diseases, new targets have emerged for which no currently available antibody drugs exist.
The role of recombinant antigens and antibodies in the COVID-19 pandemic response The COVID-19 pandemic saw a tragic worldwide loss of life, but this period also highlighted several positive aspects of the biopharma industry that are normally not widely considered. In January 2020, the company produced key SARS-CoV-2 spike protein reagents in a record time of just 11 days, and in December 2021, it developed the Omicron RBD protein in a new record time of just six days.
These antibody pairs are especially important due to their roles in therapeutic, vaccine, and diagnostic research in areas such as influenza, COVID-19, RSV, and many other fields of immunology and virology. The goal is always to ensure best-fit strategies, generating high-performing antibodies with the right properties for the target applications. The approach to this will vary and depends mainly on what the client seeks to achieve.
Sino Biological's highly optimized mammalian cell expression platforms can accommodate proprietary culture media, expression vectors, transfection reagents, supplements, and boosters. Sino Biological’s proven cell-free development platform has successfully produced proteins and antibodies that have been historically challenging to express in other systems with shorter lead times. In these instances, the cell-free development platform has been instrumental in accelerating customers’ research and development processes.
Therefore, process optimization is imperative for projects working with these antibodies. Sino Biological is adept at optimizing the production of customers’ IgM and IgA antibodies, ensuring the consistent delivery of high-purity products.Sino Biological has completed numerous antibody fragment production projects, demonstrating proficiency in each instance and leveraging its thorough experience in producing and purifying diverse antibody fragments.
In October 2023, Sino Biological formally announced the opening of its new Center for Bioprocessing in Houston, Texas, marking a key milestone in the company’s global presence. This new bioprocessing center specializes in CRO services, including developing and manufacturing custom recombinant proteins and antibodies.
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