Webinar

Taking a recombinant protein from milligrams to GMP-ready scale is where development programs truly succeed or fail. Join this expert-led webinar to explore the critical decision points that impact scalability, quality, CMC readiness, and time to clinic, with real-world insights you can apply immediately. Key learning objectives: - Navigate expression system selection (microbial, mammalian and...

Antibody-drug conjugate (ADC) development continues to evolve, with increased molecular complexity leading to new opportunities and challenges across design, development, and manufacturing. The industry is advancing novel technologies to support these next-generation antibody therapies and is adopting workflows better suited to their unique development considerations. In this webinar, we will examine how development teams address...

Join Viralgen, Genosafe and DarkHorse Consulting as they discuss their experience with novel capsid manufacturing, analytical testing and regulatory guidance. Key learning objectives: - Ways to address the complexity of novel capsid manufacturing - Approaches to consider with the analytical testing of novel capsids - Regulatory considerations around novel capsids

This webinar shows how a system-based primary packaging approach—like the West Synchrony™ prefillable syringe system—can streamline tech transfer, simplify GMP qualification, and reduce complexity, cost, and timelines for injectable drug manufacturing. Key Learning Objectives: - How injectable technology transfer impacts project timelines, cost, and risk when working with a CDMO - Where primary packaging decisions...

The webinar also highlights the growing role of AI within regulated manufacturing environments. Rather than treating AI as an add-on, the session outlines how to embed it into validated frameworks to support predictive maintenance, yield optimization, and faster product release cycles.

This webinar series explores two powerful, complementary disciplines that CDMOs leverage to tackle these challenges head-on. First, we examine the solid-state domain, exploring how targeted crystallization development can directly address purification, filtration, stability, and processability challenges from lab scale through commercialization. Then, we see how chromatographic modeling tools in combination with innovative techniques like “fraction...

CHO expression continues to evolve, and recent advances are reshaping how quickly and efficiently high-performing cell lines are developed. In this webinar, experts explore the latest innovations in the GS® Expression System, highlighting how advanced vector design, stronger selection stringency, and enhanced promoter control are driving higher titers, more stable pools, and faster timelines from...

Immune checkpoint inhibitors have transformed cancer treatment, but response rates remain limited, and immune-related toxicities continue to pose challenges. Gene editing of therapeutic T cells offers a promising path to help enhance specificity and safety by directly modulating checkpoint expression. In this webinar, we explore how gene-edited T cells targeting PD-1 and TIGIT can improve...

Bringing innovative antibody therapeutics to market quickly requires more than upstream efficiency. It demands adaptable and robust downstream purification strategies. As novel mAb formats increase in complexity, purification challenges grow. Achieving required purity and yield often extends beyond traditional 2–3 step platform processes, requiring expanded chromatography options and optimized buffer systems. In this webinar, we...

Technology transfer to a CDMO is rarely as simple as handing over a data package. From documentation gaps and equipment differences to method variability and global standards, many programs encounter avoidable risks that can derail timelines and increase cost. In this Outsourced Pharma Live session, industry experts share practical strategies to help sponsors better prepare...

In this webinar, Lonza experts share insights from 70+ bispecific programs, revealing the most common early‑stage risks across analytical development, downstream purification, and drug product formulation. You’ll learn where challenges typically emerge before IND, how early decisions shape CMC readiness, and when to rely on platform approaches versus molecule‑specific strategies to avoid costly delays. Key...

This webinar breaks down how evolving expectations under ICH Q5A(R2) are reshaping viral detection strategies, shifting the industry from targeted testing toward broader, more sensitive approaches. Through real‑world examples, you’ll learn where current methods fall short, how newer technologies expand visibility, and how teams can strengthen viral safety programs without disrupting development timelines or regulatory...

IND submission is a critical milestone in mAb development — but analytical methods established at this stage must ultimately support validation, tech transfer, and evolving regulatory expectations. Among these, residual host cell DNA quantitation assays play a central role in monitoring residual impurity levels, supporting process performance, and may help reduce downstream risks. This webinar...

Explore how advanced nanoparticle engineering is transforming formulation across both small and large molecule modalities. Dr. Chris Worrall highlights how Nanoform’s technologies enable higher drug‑loading oral tablets, ultra‑high‑concentration biologic formulations for SubQ delivery, and new possibilities for pulmonary administration. Through real case studies, you’ll see how nanoforming can reduce pill burden, unlock patient‑friendly alternatives to...

In this session, leading cell therapy CDMOs will break down how they support programs across development—from early process work through GMP manufacturing, scale-up, and commercial readiness—and where different approaches can reduce downstream risk or introduce it. This is a focused look at who does what, and where they fit—so you can evaluate partners with greater...

In this session, leading CDMO experts will break down the key decisions across host cell selection, vector design, and clone screening strategies, and explain how those choices impact expression, scalability, and long-term manufacturability. These presentations will highlight how different CDMO approaches can reduce downstream risk or introduce it, as programs move from early development into...

Clinical trials sit at a unique intersection of science, patients, and clinical care, and for decades, the “gold standard” has prioritized the rigor of the data, often at the expense of the patients providing it. This gap between rigid protocol requirements and the realities of patients' lives is a primary driver of participant hesitancy and...

Join us for this digital event designed for pharmaceutical and biopharmaceutical companies seeking reliable CDMO partnerships to accelerate their microbial programs from development through commercial manufacturing. By attending this digital event, you will learn how these capabilities come together to support efficient development, smooth scale-up, and consistent production. The presentations will also provide insight into...

In this Capabilities Update, CDMOs will share how they support ADC programs from early development through clinical and commercial manufacturing. By attending this digital event, you will gain insight into the technical expertise, scalability, and regulatory considerations required to advance ADCs efficiently. The presentations will also highlight key considerations when evaluating CDMO partners, including experience...

Given its inherent time and resource demands, variability in productivity, and the rising complexity of monoclonal antibody (mAb) modalities—including bispecific antibodies (bsAb) and fusion proteins—cell line development (CLD) has become a leading constraint on bioprocess development. Designed to address these constraints, the Gibo™ CHOvantage™ GS CLD kit is a transposon-based CHO-K1 CLD platform that offers...

As biomanufacturers face increasing pressure to boost productivity, reduce costs, and accelerate timelines, traditional scale-up approaches can introduce variability and performance drift. Intensified upstream processing offers a more scalable, efficient path forward—helping maintain product quality, process stability, and regulatory compliance from development through GMP manufacturing. In this webinar, Thermo Fisher Scientific experts share best practices...

Study build inefficiency is rarely caused by a single failure point. Instead, delays accumulate across fragmented protocol interpretation, manual configuration, iterative amendments, and validation cycles that often surface issues late—when they are more costly to resolve. For many sponsors and CROs, this has become the accepted baseline. The more important question is whether it needs...

Bioprocess Online's Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and...

Bioprocess Online's Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and...

As sterile pharmaceutical manufacturing evolves, isolators and Restricted Access Barrier Systems (RABS) have become central to contamination control strategies across global markets. Yet regulatory expectations from the FDA, EU GMP Annex 1, PIC/S, and WHO differ in meaningful ways, from legal enforceability to technical prescriptiveness, creating compliance complexity for manufacturers supplying multiple markets. This webinar...

Join this webinar to learn how leading cell therapy developers are tackling one of the field’s biggest challenges: scaling non-viral gene-edited cell therapies from research to manufacturing. Through real-world data in T, NK, and CD34+ cells, experts will demonstrate how electroporation can enable efficient CRISPR knock-out, knock-in, and transposon-based editing while preserving critical cell quality...

Bioprocess Online's Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and...

False rejects are more than a nuisance—they create unnecessary waste, disrupt production efficiency, and erode confidence in inspection systems. In this webinar, we will explore the top 10 causes of false rejects across system setup, environmental conditions, and product and operational variability. We will also demonstrate why false rejects are not inevitable, but instead indicators...

In this webinar, Revvity Signals will explore how Signals Clinical applies governed, fit-for-purpose AI within clinical data review workflows. The discussion will focus on practical ways to accelerate review while keeping clinical experts in control.