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From Pipettes to Infusion Pumps: Volume Accuracy in Regulated Industries and Its Critical Impact
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Special Reports
As the monoclonal-antibody (mAb) market continues to grow, it is becoming increasingly important for pharmaceutical and biotech companies to accelerate process development and establish a scalable manufacturing process capable of achieving high titers and consistent product quality. Central to this is a cell culture media and feed system that can provide the required nutrients for optimal cell growth, viability, and function, as well as facilitate a seamless transition from development to clinical and commercial manufacturing. However, choosing an appropriate system can be a complex and time-consuming process, often requiring the evaluation of multiple medium and feed options. Platform systems, consisting of a medium and complementary feed developed for a specific cell line and application, have emerged as a valuable option for developers to help simplify selection and increase scale-up efficiency. To meet the need for high-performance platform mAb manufacturing solutions, Thermo Fisher Scientific has dev...
Precision in volume delivery is critically important for both the biopharmaceutical and medical device industries. This special report discusses how accurate volume measurement affects patient safety, product quality, and regulatory compliance. Sartorius emphasizes the roles that infusion pumps, laboratory pipettes, and quality control (QC) measures play in ensuring reliable and reproducible results. Register or Login and hit Download Now to get the full Special Report.
Ask the Expert Webcasts
This webcast features: Bingquan (Stuart) Wang, PhD, Senior Director, US-EU CMC Management, WuXi XDC. Antibody-drug conjugate (ADC), is one of the fastest growing fields in therapy for life-threatening diseases. Its novel mechanism of action, target for unmet serious diseases and significant therapeutic effect has led the expedited development and approval of several new ADC drugs. However, ADC development presents unique and serious challenges. The combination of a large molecule and a small molecule increases complexity and therefore slows down progress. Producing the native antibody and the drug and linker requires multiple processes, as does drug substance conjugation and drug product manufacturing. Additionally, various assays are essential to support manufacturing, characterization, and release and stability testing. Overcoming these hurdles requires advanced CMC expertise and innovative technology. Key Takeaways: Register or Login and hit Watch on Demand to view the recorded webcast now.
This webcast features: Hakyung Kim, Senior Scientist, Upstream Process Development & Dongyoung Park, Senior Scientist, Upstream Process Development, Samsung Biologics. Recent innovations in intensified fed-batch (IFB) processing have dramatically improved cell culture yields and scalability, offering a powerful solution for optimizing biopharmaceutical production. By incorporating the IFB approach, Samsung Biologics has developed a platform that optimizes crucial process parameters to maximize the productivity of cultured cell lines. Join Samsung Biologics for this webinar as they explore the latest advancements in IFB processing and discuss how our novel platform, S-Tensify™, ensures consistent quality and productivity in an increasingly complex production landscape. Key Takeaways: Register or Login and hit Watch on Demand to view the recorded webcast now.
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