The increasing demand for process analytical technologies in biopharma is a result of pressure from the market and regulatory agencies to reduce development times, improve yield and transition to lights-out manufacturing - while maintaining product quality. Waters Technologies offers a complementary set of advanced PAT tools that address these needs in upstream and downstream processing for biopharmaceuticals and gene therapies: BioAccord™ at-line, walk-up LC-MS, PATrol™ online UPLC with automated process sampling, and ultraDAWN™ real-time MALS & DLS for inline and online monitoring of biophysical attributes. This webinar will provide an overview of these three instruments and how they are used to accelerate process development and improve process control.

Key Learning Objectives:

• How Waters’ PAT solutions integrate with upstream and downstream unit operations and digital infrastructure
• How this suite of PAT technologies positions Waters as a strategic partner in advancing biopharmaceutical and gene therapy manufacturing.
• How Waters’ PAT solutions differ from its analytical lab instrumentation

Speakers:

Dan Some
Sr. Principal Product Manager
Waters

Caitlyn Da Costa
Principal Product Manager
Waters Corporation

Rana Sader
Principal Product Manager
Waters Corporation

Customer case study on how the right Data Platform delivers end‑to‑end bioprocess data integration, unifying upstream and lab instruments into a contextualized, searchable data layer for high‑fidelity analytics. Standardized real‑time dashboards and automated experiment run summaries reduce manual effort and error, enabling faster insights, cross‑site comparability, and accelerated tech transfer.

Speaker:

Darshak Shah
Principal Digital, Data & Analytics Engineer
Zaether

We will quickly address the specificity of ADCs and how it combines the need for high quality targeting antibody and careful cytotoxic payload selection and conjugation technology to achieve clinical efficacy and safety. The manufacturing, formulation, supply strategy, vendor selection and quality attributes of each component will be discussed from a CMC, cost and timelines standpoint considering stage appropriate development and late stage readiness..

Speaker:

Olivier Marcq
Senior Vice President - CMC
Tubulis

In this two-part session, Demeetra will showcase how Cas-CLOVER—the “clean alternative to CRISPR/Cas9”—is more than just a precise gene editing tool; it is a strategic business advantage. Jack Crawford, CEO, will cover how Cas-CLOVER addresses the dual challenge of securing robust commercial freedom to operate (FTO), compared to Cas-based editors, while also delivering scalable performance beyond slower, less reliable technologies such as Zinc Finger Nucleases (ZFNs). With straightforward licensing processes, free from milestones or royalties, Cas-CLOVER not only improves ROI but also positions biopharma companies to build and expand future-ready bioproduction pipelines.

Next, Corey Brizze, Ph.D., Director of Gene Editing, will present the scientific foundation of Cas-CLOVER’s transformative impact on host cell optimization. This session will feature case studies and performance data illustrating Cas-CLOVER’s knockout and targeted integration efficiency, as well as multiplexing for host cell protein (HCP) removal. Attendees will gain a clear roadmap for seamlessly implementing Cas-CLOVER—from discovery through commercial therapeutic development—empowering them to build the industry-leading bioproduction platforms of the future.

Speakers:

Jack Crawford
CEO
Demeetra

Corey Brizzee, Ph.D.
Director of Gene Editing
Demeetra

In our webcast, we will explore the evolving landscape of technology transfer (TT) in biologics manufacturing, highlighting the vital role of CDMOs, best practices for successful outcomes, the impact of digital transformation, and regulatory compliance.

Key topics include:

• Strategic Importance of CDMOs: CDMOs now account for half of global biopharma manufacturing, with 65% of pre-clinical biotech companies relying on them due to limited GMP facilities.
• Best Practices for Tech Transfer: Success relies on comprehensive planning, risk management, science-driven process transfer, and adherence to regulatory guidelines.
• Digital Transformation: The use of digital platforms, real-time monitoring, and automation fosters a “single source of truth” for effective collaboration and troubleshooting.
• Regulatory Focus: Aligning the tech transfer process with ICH Q10 and FDA guidelines is essential for ensuring product quality and regulatory compliance.

Speaker:

Miguel Carrion
Vice President, Process Development and MSAT
Bora Biologics

Dual payload Antibody Drug Conjugates have emerged as a promising modality to combat resistance mechanisms in patients, but novel conjugation strategies are required to enable production of this exciting therapeutic class.

• Payload selection criteria for dual-payload Conjugates
• Evaluation of conjugation strategies for use in dual-payload Conjugates
• Introduction of the CysTyr platform for production of Multi-Payload Conjugates and review of differentiated activity in resistance models

Speaker:

Marco Lobba
CEO
CatenaBio