Newsletter | August 8, 2025

08.08.25 -- Accelerating Gene Therapy Development For NEDAMSS

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Be the catalyst for change at BioProcess International (BPI) 2025, September 15–18 in Boston. Join 3,200+ leaders for 100+ sessions across 5+ tracks on analytics, cell culture, manufacturing strategy, and more. Network at receptions, explore the exhibit hall, and celebrate at the Museum of Science party. Register with code VERT10 to save 10%.

FOCUS ON PROCESS ENGINEERING

Here's What Limits AI's Outlook For Replacing Knowledge Workers

Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.

Accelerating Gene Therapy Development For NEDAMSS

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Protein Manufacturing Utilizing A Titerless Baculovirus Platform

Explore how an innovative titerless baculovirus platform accelerates protein manufacturing with enhanced scalability, reproducibility, and long-term virus stability for cutting-edge biologics production.

Enhancing Viral Clearance Prediction And Process Optimization

Learn about a technology that enables early, in-house viral clearance assessment, helping biopharma developers reduce costs and enhance safety before GMP manufacturing begins.

Enhancing Process Development With Viral Clearance

Streamline mAb purification with confidence. Learn practical considerations for developing processes with advanced mixed-mode chromatography, ensuring superior impurity and viral clearance from the start.

How Process Intensification Supports A Sustainable Future

Discover how process intensification is revolutionizing bioprocessing by boosting efficiency and reducing waste. Hear from experts on how these innovations are driving a more sustainable future.

Using Next Generation Sequencing To Test Raw Materials

Explore the use of NGS to proactively screen raw materials in biopharmaceutical manufacturing, which aims to reduce viral contamination risks from animal-derived reagents.

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time

As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

Digital Enhancements For Operational Excellence

Unlock operational excellence with digital enhancements. Discover practical strategies to reduce errors, streamline processes, and drive continuous improvement across industries.

Improving The Sensitivity Of Multicolor Microscopy Techniques

Single molecule fluorescence (or Förstner) resonance energy transfer (smFRET) is used to measure distances at the 1-10 nanometer scale in single molecules, typically biomolecules.

Predicting Viral Clearance In Downstream Process Development

Optimize purification steps and determine with confidence whether process steps and parameters are effective before investing resources in regulatory supporting validation studies using live virus.

Mitigating Early Development Risks

Discover how the efficient screening of biologic candidates accelerates the discovery process, reduces costs, and improves the likelihood of commercializing safe and effective drugs.

Engaging Early In Process Development To Bring mRNA Sequences To Life

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

PROCESS ENGINEERING SOLUTIONS

A Study On At-Line Titer Analysis In Biopharmaceutical Applications - RedShiftBio

High Efficiency Cell Engineering From Concept To Clinic - MaxCyte, Inc.

Process Development Services - RoosterBio

FOCUS ON SUPPLY CHAIN

Deep Interpretation Of GMP Product Quality

Explore key aspects of GMP-grade raw materials in CGT manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Four Common Types Of Cryogenic Studies For Advanced Therapies

Examine why cryopreservation studies are so critical and how biopharmaceutical manufacturers can more easily navigate the complexities of this process.

New Container Protects Bulk Frozen Biopharmaceuticals

Learn more about a flexible freeze container that maintains package integrity after freezing at -86 °C. (-123 °F) through its durable design, minimizing product loss due to package failure.

SUPPLY CHAIN SOLUTIONS

The Connectors Solution For Cryogenic Freezing Applications - CPC

Single-Use Flexible Freeze Containers For Bulk Drug Substance - W.L. Gore & Associates

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