Newsletter | November 21, 2025

11.21.25 -- It's Not Just You, Everyone's Talking About OPV

SPONSOR

Webinar: The mRNA Journey: From Design to LNP-Ready Molecules for Research

Discover a validated, end-to-end workflow for producing high-quality IVT mRNA for preclinical research. This Agilent webinar covers every step—from sequence design and PCR-based DNA template preparation to transcription, lipid nanoparticle formulation, and QC testing with Agilent TapeStation and Fragment Analyzer—enabling fast, reliable, small-scale mRNA production for vaccines, protein expression, and gene or cell therapy. Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

It's Not Just You, Everyone's Talking About OPV

Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

Maximize Your Laboratory Efficiency

Gain insight into how labs can boost productivity by reducing downtime, minimizing errors, and increasing walk-away time through real-time insights and analytics.

Determining The Linear Range For Quantitative Western Blot Detection

Discover how to determine the linear range for western blot quantification using total protein stains or housekeeping proteins to ensure accurate normalization and avoid saturation effects.

Automated Active Microbial Collection In Aseptic Filling Lines

Learn how automated environmental monitoring strengthens contamination control strategies, reduces risk, and supports intervention planning in aseptic filling lines.

Purification And Solubilization Of Membrane Proteins For Cryo-EM Studies

See how Cube Biotech and MIT researchers used dynamic light scattering (DLS) and nano differential scanning fluorimetry (nanoDSF) to find the best nanodisc conditions for three membrane proteins.

How Digital Procedures And E-Logbooks Are Transforming Manufacturing

Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Discover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.

Tackling High Costs Of Developing AAV-Based Therapeutics

Resolve monomers from dimers across AAV serotypes with a breakthrough solution that cuts sample use by up to 90%, accelerates development, and reduces costs—transforming gene therapy workflows.

Principles And Practice Using SEC For Reliable Peptides Analyses

Discover new SEC columns that enable reliable separation of biotherapeutic peptides to enhance CQA measurements for improved safety, efficacy, and quality across LC platforms.

Best Practices In HCP Assay Development

Learn the best practices in HCP immunoassay development, common mistakes and misconceptions , and advanced orthogonal methods of immunoaffinity chromatography and mass spectrometry.

Don't Let Seals Break Your Batch: Inside Risk-Based Column Maintenance

Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

Scientific Insights Into VHP Biodecontamination And BI Quality Management

VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.

Pushing Boundaries In Protein Structure-Function Analysis

Discover the advantages of MMS over CD spectroscopy for analyzing protein higher-order structures. See how MMS accurately identifies subtle changes crucial for understanding protein function.

Optimizing DSP Development: Faster Timelines And High-Quality Processes

The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

Electroporation Enables Efficient Antibody Discovery By Mammalian Display

Achieve greater sequence diversity and library coverage in antibody discovery. Learn about an approach enables reproducible and scalable transfections, leading to the identification of better antibody candidates.

A Dilute-And-Shoot Method For Monitoring mAb PQAs From Spent Media

Learn more about an assay that innovatively measures monoclonal antibody PQAs directly from cell culture media and offers comprehensive insights into charge and glycoform heterogeneity to simplify upstream bioprocessing.

Simplified Workflow Using Automated Instrument Setup And Compensation

Examine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis.

Evaluating A Xeno-Free Serum Replacement Media Supplementation

This study compares the impact of a specific Human Growth Factor Concentrate (hGFC) and fetal bovine serum (FBS) on the growth, expansion, and viability of MSCs.

Microbial Air Sampling: Physical And Biological Collection Efficiencies

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

Operational Readiness In Pharma

Operational Readiness bridges project delivery and GMP manufacturing to ensure systems and teams are prepared for execution. Discover how a digital validation platform streamlines this transition.

Clean, New, Bioenergy Sources: One Molecule At A Time

Conversion of cellulose to bioethanol has huge potential to positively impact the global energy crisis, helping enable a shift away from fossil fuel dependency.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Accelerate Discovery In 2D And 3D Cell Imaging - LICORbio

Accelerate Batch Releases With Right-First-Time Execution - Tulip

Streamline Your Lab Workflow Through Flexibility And Automation - BD Biosciences

Frequently Asked Questions About Stability Profiling Experiments - NanoTemper Technologies, Inc.

Ensuring The Safety Of Cell Therapy Manufacturing Through Quality Control Solutions - ACROBiosystems

FOCUS ON REGULATORY

Addressing The PAT Developability Gap

In this segment from the Bioprocess Online Live event, “Aligning CMC And MSAT To Move PATs Out Of Pilot Mode,” our panelists discuss how organizations can develop a PAT continuum or program that aligns development teams and manufacturing teams in PAT adoption and use.

Why The Latest E2500-25 Standard Revision Demands Immediate Action

The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

Laying Supply Chain Foundations That Bring Confidence To Compliance

Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

Measuring Cleanliness

Cleanliness can be detected to varying degrees or levels. Learn about methods of detecting and measuring cleanliness in relation to soil quantities.

Test Kit Management: The Weak Point In Your Visual Inspection Program

A proper test kit management program is no longer a “nice-to-have”—it’s a compliance necessity. Without a structured system, you risk inspector drift, failed audits, and errors in batch release.

REGULATORY SOLUTIONS

Innovating Unmet Needs For Next-Generation Cellular Immunotherapies - Femtobiomed Inc.

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