Antibody therapeutics are the largest class of biotherapeutics. Over the years, development beyond traditional monoclonal antibodies (mAbs) has increased. Today, we see multispecific and bispecific antibodies, antibody fragments, and antibody drug conjugates in the development pipeline. Manufacturing platform approaches conveniently used for many traditional mAbs are being adopted or tweaked to fit the respective molecule. In this ebook, you will learn about considerations and tips for developing chromatography protocols for antibody variants.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions
April 14th 2025Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance
April 14th 2025Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.