Newsletter | October 24, 2025

10.24.25 -- What You Should Know About USP's Bioassay Updates

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 QUALITY/ANALYTICAL METHODS

Using PATs For Real-Time Process Monitoring

In this segment from the Bioprocess Online Live event, “Aligning CMC And MSAT To Move PATs Out Of Pilot Mode,” our panelists respond to results from an audience poll. Audience members indicated they use PATs for real-time process monitoring more in upstream than in downstream.

Analytical Techniques For Characterization, Release, And Stability Testing

Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.

Real-Time Viable Particle Monitoring: How Does It Work? How Can It Help?

In aseptic manufacturing, laser induced fluorescence shows great potential to replace growth-based methods in certain manufacturing paradigms — highly automated, near-continuous processes.

How Particle Counting Efficiency Affects Distribution Data

Counting efficiency and resolution are key to accurate particle data in optical particle counters. Examine how counting efficiency impacts data interpretation in critical environments like cleanrooms.

Multicolor Flow Cytometry Panel Design

Watch a series on multicolor flow cytometry panel design to gain a comprehensive understanding of the fundamentals of panel design as well as various strategies to streamline panel design.

Enhanced Structural Characterization Of Thermal Unfolding With MMS

Explore the power of Microfluidic Modulation Spectroscopy (MMS) in resolving distinct melting behaviors and domain-specific unfolding events for biologics, providing crucial structural insights.

Manual CQV vs. AI-Powered CQV

Still validating the manual way? With AI-powered CQV, you can reclaim hours lost to protocols and audit prep. What used to take weeks is now done in minutes.

Protecting CAPEX Budgets Through Digital Validation

Streamline your CAPEX validation to accelerate growth, reduce costs, and bring your product to market faster. Discover how futureproof digital validation can protect your budget and maximize value.

Vision Inspection Software: The Missing Link In Digital Transformation

AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

Unlocking miRNA Biomarkers With NGS And Digital PCR

Discover how next-gen sequencing and digital PCR enable miRNA biomarker discovery and validation. Learn best practices for sample prep, data analysis, and assay design to advance RNA research.

Enhancing Throughput And Reproducibility In Proteomic Analysis

Streamline proteomic workflows with consistent sample preparation. Learn how simplifying LC-MS processes can eliminate bottlenecks, improve reproducibility, and accelerate drug discovery research.

5 Ways To Drive Lab Sustainability

Laboratories drive innovation, but their environmental impact is growing. Discover five practical tips to make your lab more sustainable to reduce waste, and support global climate goals.

Excipient GMP: Elevating Standards In Cell Culture Solutions

The quality of non-active ingredients, or excipients, directly impacts product safety and efficacy. Learn why Excipient GMP is vital for cell culture solutions and how it elevates manufacturing standards.

Comparing Microfluidic Mixing With A Turbulent Jet Approach For LNPs

A comparative study examines how two mixing technologies, microfluidic and turbulent jet, influence the attributes of lipid nanoparticles and their suitability for different stages of drug development.

Antibody Coverage Analysis Of E. coli HCPs In The BL21(DE3) Strain

Review a study conducted to determine the suitability and similarity of Cygnus E. coli HCP ELISA Kits to quantify BL21(DE3) Host Cell Proteins (HCPs).

Real-Time Monitoring Of Key Bioprocess Parameters

The success of this experiment shows how the integration of Process Analytical Technology probes into bioreactors can enhance process understanding and enable precise bioprocess monitoring and control.

Optimization Of Membrane Proteins For Cryo EM

Discover how to optimize membrane proteins for cryo-EM. Experts reveal a data-driven workflow using NativeMP Copolymer Technology and a multi-parameter tool for detergent-free stabilization.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Transform GMP Data Into Actionable Intelligence - Blue Mountain

Understand Your Stability Programs - MilliporeSigma

Microcalorimetry: ITC & DSC - TA Instruments

A Tool For Rapid Quantification Of Nanoparticles - Corning Life Sciences

SPONSOR

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.

FOCUS ON REGULATORY

What You Should Know About USP's Bioassay Updates

The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

Safeguarding Quality In Parenteral Drug Manufacturing

Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

EU GMP Annex 1 Compliance: Global Requirements And PIC/S Alignment

The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.

Next-Gen AOC, RDC Programs From Lead Candidate Design To Manufacture

AOCs and radionuclide-drug conjugates (RDCs) rely on very different components, design strategies, and development paths. To move these modalities forward, science, strategy, and structure need to align.

Risk Assessment Aligns With FDA Guidance For Gene-Edited Products

Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.

Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It

Learn how thorough cleaning and process optimization prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.

SPONSOR

Webinar: Developing your risk-based approach to single-use system integrity

This session explores best practices and evolving regulatory expectations for single-use system (SUS) integrity. Attendees will learn how to apply a holistic, lifecycle-based approach to compliance, define clear user requirements, and build robust contamination control strategies. By the end, participants will be prepared to safeguard efficiency and product quality while meeting regulatory and industry standards. Click here to learn more.

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