Regulators are moving the comparability goalpost, shifting the burden of proof from massive clinical trials to deep process understanding. In this new landscape, the ability to define and control CPPs is the only way to ensure a biosimilar remains highly similar to its reference. Join Bioprocess Online’s Jon O’Connell for a virtual Q&A with experts...
Explore how KBI Biopharma delivers fast, cost-effective, and robust microbial protein process development, tailored for first-in-human (FIH, Phase I) programs and adaptable to each client’s needs for speed, cost, and performance. Learning Objectives: - Key considerations for microbial cell line, fermentation, and purification development for FIH - How milestones align from proof-of-concept to toxicology material...
Asset Performance Management (APM) has evolved far beyond reactive maintenance - but many organizations are still navigating how to get there. In this session, Chief Platform Architect at Blue Mountain, Bill Lucas, walks through the industry’s APM maturity journey, tracing the shift from breakdown-driven maintenance to predictive and AI-powered optimization.
LSX World Europe (LSX Europe) is a leading life science fundraising and investment event, bringing innovators and investors together through strategic 1:1 meetings and targeted networking. Early-stage (Seed–Series B) biotech, medical device, diagnostics and digital health companies, including university spin-outs - join to secure investment and build collaborations. Active life science investors attend, looking for...
Learn how leading manufacturers are connecting manufacturing, quality, and supply chain systems to improve visibility, accelerate decision making and create more agile operations. The session will explore how organizations are strengthening supply chains and preparing their workforce for increasingly digital manufacturing environments.
Returning to Boston this March Connect with Fellow Leaders Shaping Cell and Gene Therapy Development The eighth in a series of premier one-day events held in the world's biggest biotech hubs, Charles River is bringing together the leading experts, executives, and thought leaders in the CGT space to discuss and navigate critical challenges. Register today to...
As biologics grow more complex and development timelines continue to tighten, many teams could encounter manufacturability challenges related to decisions around media, process, and scalability made earlier in development. Traditional, sequential workflows may not always surface potential challenges until programs are already moving toward scale-up, which can limit flexibility. In this webinar, Thermo Fisher Scientific...
AI is reshaping every industry—and drug discovery is no exception. Across targets, molecules, and data at massive scale, AI is becoming integral to how modern therapeutics are discovered and developed. This panel explores how foundational open‑source AI engines like OpenFold and Boltz are being used across the drug discovery workflow, from target discovery and validation...
In today’s fast-paced biopharma and CDMO environments, single-use assembly design is about confidence in quality, supply continuity, and process performance. This webinar explores how Thermo Scientific™ Single-Use Assemblies are designed to help reduce risk, support flexible manufacturing, and help organizations meet production milestones and maintain momentum when time to market is crucial. Attendees will see...
Phase 2 neurodegenerative trials are increasingly challenged by slow disease trajectories, heterogeneous patient populations, and blunt legacy endpoints that struggle to detect treatment-related change over typical study durations. Traditional scales such as ADAS-Cog and MDS-UPDRS, while well-established, often lack sensitivity in early disease, are vulnerable to rater and practice effects, and may insufficiently capture subtle...
