Monoclonal Antibodies, from science to manufacturing production with TECNIC's Biotech Solutions

Even though mAbs products with simplified glycosylation are suitable for lower organism expression platforms, whole therapeutic mAbs tend to require a mammalian expression system to produce the biologically functional product, as they may need to glycosylate, fold, orient, and correctly in order to produce the complete biologically functional monoclonal antibody product. For that reason, manufacturing a biologically functional whole mAb product is therefore commercially unfeasible through chemical synthesis and insufficient on lower organism expression platforms (bacteria or yeast), as they may not have the machinery to produce the equivalent tertiary structure and glycosylation profiles. The challenge is that, in terms of manufacturability and scalability, mammalian cells have been considered difficult to work with due to factors such as low yield, medium complexity and serum requirements.

Overcoming this challenge involves not only selecting highly productive clones, but also optimizing medium composition and bioreactor operational conditions to enhance specific productivity per cell. This multifaceted approach is instrumental in achieving a seamless and efficient antibody production process, ensuring success at various scales of operation. TECNIC's advanced bioprocessing solutions, with precise control culture conditions in bioreactors and tangential flow filtration systems, can help you address these complexities and provide valuable support to streamline and enhance monoclonal antibody production processes.

Whether in research or industrial applications, antibody production presents a myriad of challenges to ensure efficient and reliable outcomes. Striking a delicate balance between high yields, quality, and cost-effectiveness is crucial to optimize its production and costs. However, addressing the variability in yields and quality stemming from cell line heterogeneity, culture conditions, and purification techniques requires adept handling to ensure consistent results. Moreover, the transition from laboratory to industrial-scale production introduces additional complexities, demanding careful optimization of culture conditions and purification methods.

This scaling-up process presents its own set of challenges that must be meticulously addressed to maintain the integrity of the production. For that reason, TECNIC's advanced bioprocessing equipment is designed with scalability in mind, making it the ideal solution to manufacture monoclonal antibodies. We ensure a seamless transition from laboratory to industrial-scale production, providing automatic, efficient and reliable solutions throughout the entire process.

The secretion of the mAb product for purification is suboptimal for several lower organism expression platforms, such as E. coli due to poor productivity and harsh culture conditions that promote product degradation. Therefore, mAbs are usually produced intracellularly, as inclusion bodies and harvest involve further processing steps such as cell lysis, inclusion body recovery, protein solubilization, and renaturation prior to further downstream purification steps. This end phase purification step is crucial, but it needs to be taken into consideration that it lets the mAb product exposed to harsh pH and salt conditions, which can chemically degrade the product.

Taking that into consideration, TECNIC's Tangential Flow Filtration Systems (TFF) offer an ideal solution for the purification of mAbs. Our TFF equipment provides an automated and controlled environment, allowing for precise management of pH and temperature conditions throughout the purification process. With TFF, the risk of chemical degradation is minimized, ensuring the preservation of the mAb product's integrity.