Newsletter | August 22, 2025

08.22.25 -- FDA Priority Voucher Program Submissions Window Opens On New Website

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FOCUS ON SUPPLY CHAIN

FDA Priority Voucher Program Submissions Window Opens On New Website

The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

Resolving Common Single-Use Concerns

Demand for single-use tools, components, expertise, and capabilities continues to grow as innovative cell therapies evolve. However, concerns and misconceptions abound regarding single-use solutions.

4 Ways To Prepare For A Fetal Bovine Serum (FBS) Shortage

To prepare for an FBS shortage, secure reliable suppliers, validate backups, stock reserves, and consider alternative sourcing. Corning offers high-quality FBS and expert supply planning support.

Flexible Freeze Containers In Gene Therapy Manufacturing

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.

Boost Your Lab's Performance: 3 Ways To Increase Efficiency

Maximize your research potential by overcoming workflow bottlenecks. Explore flexible strategies for increasing throughput and integrating automation seamlessly into your laboratory operations.

SUPPLY CHAIN SOLUTIONS

Cryopreservation Media: NB-KUL 10 - Nucleus Biologics

FOCUS ON PROCESS ENGINEERING

Advancements In Gene Therapy Development

Advancements in gene therapy require robust analytical methods. A roundtable with experts highlights how digital PCR can assess AAV genome integrity for safe and effective therapies.

 

Bringing CRISPR Into The CAR-T Process

CAR-T cell therapy has been limited by high costs and lengthy manufacturing. Novel methods are bringing exciting advancements in CRISPR-based gene editing that hold promise for overcoming hurdles.

Process Intensification: Key Considerations And Expert Insights

Experts share their experiences implementing process intensification to provide a holistic perspective and the top considerations for your internal calculations, deliberations, and decision-making.

Accelerating The Development And Production Of High-Quality bsAbs

Bispecific antibodies (bsAbs) are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn about an innovative platform offering excellent pairing and enhanced productivity.

Securing A Treatment Through Grit And Collaboration

Discover how one family defied the odds—bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Achieving Cell Therapy Success: Reducing Costs To Improve Patient Access

To ensure the commercial success of cell therapies, developers must adopt innovative manufacturing and QC technologies that reduce COGS while enhancing scalability, quality, and clinical outcomes.

Improving Safety And Efficacy With Charged Variant Characterization

Find out how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

Scaling Up Your E. Coli pDNA Process From Screening To Pilot Scale

Learn how a systematic approach to scalable plasmid DNA production using E. coli OneShot Top10, which features DOE-driven optimization and key insights for efficient biomanufacturing success.

Scientific Poster: Development Of Relative Potency Assay For ADC

Discover how this integrated, multi-parameter assay strategy can enhance the accuracy, sensitivity, and efficiency of your ADC potency evaluations.

Reducing Device Downtime: IO-Link Enabled cGMP Biopharma Washer

Ensure precise, validated cleaning processes for your pharmaceutical projects, minimizing downtime and mitigating drug shortages that stem from manufacturing interruptions.

High Yield Protein Production System For Suspension CHO Cells

Reduced the risk of contamination caused by repeated handling of the culture during transient protein production in suspension CHO cells.

Streamline Your Pathway To IND With A Rapid Tox Approach

With tox material in hand as soon as possible, antibody-derived drug developers can conduct their tox studies earlier, facilitating a timely IND submission and speeding up pathways to patients.

PROCESS ENGINEERING SOLUTIONS

Nanopositioner Focusing Elements: Nano-F Series - Mad City Labs, Inc.

The Future Of Biomanufacturing: Innovating Process Intensification Together - Sartorius

PharmaLok ZerO Sanitary Clamps - Nordson MEDICAL

Interactive Learning For Excipients And Equipment - Federal Equipment Company

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