Media and feed development: A step-by-step guide to workflow optimization
Cell culture media is a foundational component of any biotherapeutic manufacturing workflow, crucial for maintaining cellular health and viability, maximizing titers, and supporting high product quality. As such, building a biotherapeutic manufacturing process with an optimized basal medium and feed system is vital to achieving optimal results and accelerating the speed-to-market of your product. However, the process of finding the most suitable basal medium and supplementation strategy can be challenging, as it requires balancing many key cell culture process variables to achieve specific technical goals within budget and time constraints. This guide will provide an insight into each development stage and offer best practices to help you achieve your project goals on time and within budget.
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Biophysical and Aggregate Characterization for the Development of Biologics
June 10th 2025This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance (May 2025)
May 16th 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.
Optimizing cGMP Facility Design Space with a Hybrid Approach (May 2025)
May 16th 2025In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.
