Newsletter | October 16, 2026

10.16.26 -- Bringing Next-Gen Sequencing To GMP Scale

SPONSOR

Webinar: Accelerating CHO Manufacturing: From 14-Day Fed-Batch to 10-Day Intensified Fed-batch

What if you could shorten a 14-day fed-batch process to just 10 days without sacrificing product quality? This Thermo Fisher Scientific webinar explores how N-1 perfusion intensified CHO-K1 Herceptin production using standard equipment and the same medium, while scaling from Ambr 250 to 50 L. Discover practical strategies to increase throughput, flexibility, and manufacturing capacity without significant process changes. Click here to learn more.

FOCUS ON QUALITY/ANALYTICAL METHODS

Bringing Next-Gen Sequencing To GMP Scale

NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.

Active Air Sampler Comparison In Remote Settings

Discover how optimized air sampler geometry improves microbial collection efficiency and continuous environmental monitoring accuracy to safeguard critical cleanroom operations.

Cell And Gene Therapies: Insights For Faster Batch Release

Cell and gene therapies are reshaping life sciences. Learn how quality can transition from a compliance role to a strategic partner, enabling innovation and growth during this transformative period.

A Systematic Approach To Assess Biologics Developability

See how a systematic, data-driven developability workflow can accelerate biologic formulation development, identify risks earlier, and optimize stability and manufacturability.

Building Robust Potency Assays

Robust potency assays depend on reliable biological readouts. Watch how quantitative protein expression analysis can provide sensitive, reproducible measurements of cellular responses.

How Equipment Choices Can Help Determine The Pace Of Drug Development

The speed of drug development depends as much on equipment choices as scientific expertise. Uncover how flexible, integrated tools reduce delays, improve data quality, and enable faster decisions.

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.

A Practical Approach To Regulatory Compliance And Market Success

Regulatory and quality compliance are built into every stage of biologics development, helping ensure consistent manufacturing, faster approvals, and dependable global market access.

Using Client Centricity As Fuel For Innovative Biologics Development

Complex biologics require flexible development, advanced analytics, and quality by design. Delve into how collaborative bioprocessing reduces risk, enables efficient scale‑up, and supports clinical success.

How EPR Spectroscopy Reveals Membrane Protein Structure And Dynamics

Resolving dynamic states in membrane proteins is vital for drug discovery. EPR spectroscopy tracks conformational shifts in native environments, bypassing standard structural limits.

Biologics Tech Transfer And Validation At Scale: A Better Path To GMP

Take a look at where tech transfer and validation commonly falter, and how disciplined execution helps teams maintain control through PPQ and beyond.

Lab Equipment Monitoring For The Modern Lab

Ensuring the integrity of results and maintaining regulatory compliance are paramount. Cloud-based device management offers several advantages for laboratory equipment monitoring.

Decoding AAV: Navigating Critical Quality Attributes And Their Analytics

For groundbreaking genetic treatments, stringent quality control is non-negotiable. This exploration delves into defining essential attributes and the analytical tools that safeguard their consistent production.

Five Considerations For PUPSIT Implementation

Pre-use, post-sterilization integrity testing (PUPSIT) is vital for contamination control to ensure the integrity of sterilized equipment before use. Examine how PUPSIT can enhance safety and quality.

Analysis Of LNP Lipids With Evaporative Light Scattering Detection

Jump into this thorough analysis of lipids in LNP formulations using HPLC, a technique crucial for quality control in the production of mRNA vaccines and therapeutics.

QUALITY/ANALYTICAL METHODS SOLUTIONS

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Cleanroom Essentials - ILC Dover, An Ingersoll Rand Business

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DNA2.0 - Gene Optimization And Synthesis - ATUM

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Thermal Analyzers For The Most Demanding Biopharma Applications - TA Instruments

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Secure Scalable Supply Of Critical Assay Proteins For Diagnostic R&D - Future Fields

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Improve Bioanalysis Workflows With Integrated Technologies - Agilent Technologies

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Developing A mAb For A Small Biotech Developing Precision Medicines - Lonza

SPONSOR

Webinar: Advancing drug product manufacturing with a risk-based approach to single-use system integrity

Single-use systems are widely used in biopharmaceutical manufacturing, but expectations for system integrity continue to evolve. This session explores key control points across the SUS lifecycle and how a holistic approach can strengthen contamination control strategies. Learn how clear requirements, regulatory awareness, and effective integrity strategies can support compliance, operational efficiency, and product quality. Click here to learn more.

FOCUS ON REGULATORY

Safer Single-Use Materials To Enhance Advanced Therapy Manufacturing

Single-use technology suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain safety and efficacy.

REGULATORY SOLUTIONS

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Bio-Decontamination Validation Using Enzyme Indicators - Protak Scientific Ltd

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Ready To Bring GxP Training To The Next Level? - Veeva

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