Newsletter | October 10, 2025

10.10.25 -- Derisking AI Means First Asking: Who Does It Serve?

SPONSOR

Webinar: Faster Tech Transfers Through Seamless Digital Transformation

Accelerating time to market requires moving beyond manual, document-centric methods. Join Emerson’s webinar to explore how digital platforms, standardized modular libraries, and direct connectivity to execution systems streamline process specification and enable rapid flexibility. Learn from real-world examples at a clinical supply center on how digital transfers reduce errors, improve efficiency, and support faster biopharma innovation. Click here to learn more.

FOCUS ON REGULATORY

Derisking AI Means First Asking: Who Does It Serve?

Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

The Rising Cost Of Product Recalls In Life Sciences

Product recalls are becoming a major concern in life sciences. Learn why your company must act now to strengthen quality systems and reduce risk across pharmaceuticals, devices, and biologics.

Pathway Towards Regulatory Approval: Chemistry, Challenges Behind AOCs

Explore the fundamental science behind antibody-oligonucleotide conjugates (AOCs), including oligonucleotide synthesis, bioconjugation strategies, and the challenges that arise from their properties.

Understanding FDA Calibration Requirements And Best Practices

Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.

Contamination Control Strategy With QRM Principles

Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

Building Excellence In Pharma Manufacturing Through Rigor

A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.

REGULATORY SOLUTIONS

Visual Inspection Of Advanced Therapy Medicinal Products - InQuest Science

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Webinar: Enabling Continuous Process Intelligence: In-Line PAT Solutions for cGMP Environments

Boost efficiency and compliance in bioprocessing with Repligen’s upcoming webinar on process analytical technology (PAT). Explore real-world applications of the FlowVPX® and MAVERICK® systems for real-time monitoring of critical parameters, smarter decision-making, and reduced costs. See how PAT streamlines upstream and downstream workflows, accelerates production, and supports GMP compliance—all while cutting deviations and saving valuable time. Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

Validation In Transition: 2025's Top Trends, Tools, And Takeaways

Join top validation experts for a dynamic panel discussion on the 2025 State of Validation Report—uncovering key trends, challenges, and innovations shaping pharmaceutical validation practices today.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Mastering Modern Recall Management: A 6-Part Journey To Excellence

Explore the rising challenges of recall management in life sciences. This six-part series offers expert insights and unveils a groundbreaking solution set to transform how companies manage recalls.

GMP Calibration Management

Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.

Plan And Optimize Your Western Blot Experiments

Western blotting identifies specific proteins in complex samples, using gel electrophoresis and antibody probing. Find out how it reveals protein presence, abundance, and size.

Gene Therapy In-Use And Device Compatibility Studies

Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

Overcoming The Challenges Of Modern Lab Equipment Maintenance

Modern lab equipment is essential to scientific research, but maintaining it is increasingly complex. Discover key challenges and strategies to futureproof your maintenance approach.

Detect Ultra-Rare Variants In cfDNA From Liquid Biopsy Samples

Liquid biopsy, powered by next-generation sequencing, is transforming precision oncology to offer real-time, non-invasive insights into tumor genetics, which revolutionizes how we monitor and manage cancer.

ISO Cleanroom Standards

Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Investigations into viable air excursions are difficult to perform using traditional methods. Discover why a real-time viable particle counter is key to providing process improvement.

Overcoming The Challenges Of Product Concentration Monitoring At A CDMO

See how simplified, in-line analytics are changing the way CDMOs manage product concentration in fed-batch and perfusion processes.

Five Habits For Reliable Biomanufacturing

Implement strategies to reduce unplanned downtime and keep your biomanufacturing on track with a checklist and planning to enhance reliability and resilience.

A Toolkit For Unraveling Protein Expression Patterns

Learn about a method that utilizes monoclonal antibodies and flow cytometry to analyze the metabolic state of individual immune cells, advancing immune research and immunotherapy.

Assessing A Targeted Molecular Method For Adventitious Virus Detection

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

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Webinar: Optimizing DNA clearance in high-salt, GMP-grade purification processes

Join Qiagen’s webinar to explore advanced endonuclease technology for viral vector and biologics manufacturing. Learn how Saltonase® GMP-grade enables robust digestion in high-salt environments, breaking DNA down to 3–5 nucleotides. Discover how this next-generation approach overcomes limitations of conventional nucleases, ensures ≤10 ng residual DNA compliance, enhances purity, and drives more efficient, cost-effective cell and gene therapy processes. Click here to learn more.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Make Traceability A Seamless Part Of Your Operations - Tulip

Liquid Biopsy: Accelerate Your Circulating Biomarker Research - QIAGEN

Delivering Best-In-Class Nanoparticles - DIANT Pharma

Validation And Quality Management Software Platform - CAI

How It Works: Vericheck ddPCR Empty-Full Capsid Kit - Bio-Rad Laboratories, Inc.

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Join us for November’s Bio-Expo Live, a three-day virtual event designed to empower biopharma professionals with the chance to conveniently explore the newest equipment and offerings in Upstream Bioprocessing, Downstream Bioprocessing and Bioprocess Quality, Data, and Analytical Solutions. Registration is free, reserve your spot today!

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