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Lessons in Bioreactor Scale-Up, Part 5: Theoretical and Empirical Correlations for Predicting the Mass-Transfer Coefficient in Stirred-Tank Bioreactors
Lessons in Bioreactor Scale-Up, Part 5: Theoretical and Empirical Correlations for Predicting the Mass-Transfer Coefficient in Stirred-Tank Bioreactors
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Special Reports
Stability is critical in biopharmaceutical development, affecting antibodies' efficacy, safety, and shelf life. While saccharide-based excipients are conventionally used in final formulations to ensure the stability of antibodies, Nagase Viita’s Solbiote excipients, covering injectable-grade Trehalose SG product, provide comprehensive stability solutions throughout the manufacturing process – e.g., during cell culture and purification. Exploring the potential roles of saccharide, the company presents its latest study of the influence of trehalose on the reduction of host cell-derived impurities during the antibody harvesting process. Environmental sustainability is another important concern in the industry. Solbiote excipients are manufactured in an environmentally friendly way by utilizing starch and enzymes. In this report, learn how Solbiote excipients provide solutions to enhance product stability and environmental sustainability in biopharmaceuticals. Register or Login and hit Download Now to get the...
The journey from preclinical development to commercialization of a new biopharmaceutical is long and challenging. The entire process requires persistence, adaptability, and strategic foresight. Only with a well-coordinated effort across disciplines and business functions can a new biologic drug successfully advance from laboratory to market. Partnering with a CDMO can be invaluable in navigating such challenges to provide flexibility, enabling drug sponsors to focus on their core competencies while relying on their partners to handle the intricacies of manufacturing and regulatory compliance. Such partnerships can reduce risks significantly and help ensure that a new biologic reaches the market as efficiently as possible. Learn key considerations for the journey to commercialization. Register or Login and hit Download Now to get the full Special Report.
Ask the Expert Webcasts
This webcast features: Sushmita Koley, PhD, Staff Scientist, Process Chromatography R&D, Bio-Rad Laboratories. Chromatographic purification process is a critical step in the biomanufacturing of molecules such as monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), and other recombinant proteins. After the initial capture step, polishing chromatography typically involves two to four orthogonal steps using anion exchange, cation exchange, or hydrophobic interaction chromatography. Although these traditionally operated single-mode ion-exchange chromatography methods have been employed in the downstream processing of biotherapeutics, achieving high purity and yield has often been challenging. To overcome these limitations, there has been a significant increase in the implementation of multimodal adsorbents for purification processes which not only help to reduce the number of steps, but also improves the overall process economics and achieve the sustainability goals. In this webcast, learn how Bio-...
This webcast features: Shanshan Wang, PhD, associate director, Innoforce Pharmaceuticals. The therapeutic potential of mRNA-based therapies is rapidly being recognized across various fields, positioning the mRNA sector as a fast-emerging area of innovation. Beyond conventional mRNA, circular RNA (circRNA) and self-amplifying RNA (saRNA) are gaining significant attention as promising molecules for RNA-based vaccines and therapeutics. However, the development of circRNA and saRNA faces numerous CMC challenges, including impurity removal in circRNA production (e.g., precursor RNA and nicked RNA), process scalability, integrity analysis for both circRNA and saRNA, and effective encapsulation strategies. Innoforce’s RNA Center of Excellence is dedicated to achieving scalable, high-quality production of RNA molecules, including mRNA, circRNA, and saRNA, through advanced process development and optimization. Leveraging extensive platform development and project execution experience, they have successfully add...
