Newsletter | March 18, 2025

03.18.25 -- Stop Hiring Now! Stay Virtual

SPONSOR

Webinar: Keeping Hope Alive: Transforming Rare Disease Drug Development for a Faster Cure

Join us on April 15th to explore how the rapid development of COVID vaccines sets a precedent for curative therapies for rare diseases. Learn how CDMOs expedite workflows, streamline manufacturing, and ensure reliable, scalable processes. Discover how supporting analytics and robust strategies accelerate the development, commercialization, and timely delivery of life-changing gene therapies. Click here to learn more.

INDUSTRY INSIGHTS

The High Cost Of Going Cheap

Developers often aim to cut expenses during development. Discover the long-term outcomes of cost-effective measures like using RUO leukopaks compared to investing in high-quality GMP-grade vectors.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

In Vitro Potency Assay Development For AAV SHANK3 Gene Therapy

Uncover how JAG201, an innovative AAV9-based gene therapy, leverages SHANK3's mechanism of action to transform the treatment landscape for patients.

The Benefits Of Cas9 mRNA: Precision, Control, Cost Efficiency

Unlock the full potential of CRISPR-Cas9 gene editing with high-purity Cas9 mRNA, the emerging choice for safer and more efficient genome engineering.

Tackling Cell & Gene Therapy Manufacturing Challenges

Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path from discovery to commercialization.

Mapping The Future: Mark Sawicki, Ph.D., On 2025 Trends In CGT

Learn how you can stay ahead of the evolving cell and gene therapy landscape by leveraging innovative solutions to support the continued growth and success of therapies in 2025 and beyond.

Setting The Standard For Plasmid DNA Production

This innovative approach expands the possibilities of personalized medicine, transforming lives for generations by providing innovative medicines to those in need.

Biotechnology: The Key To America's Next Manufacturing Revolution

See how a recent expansion into Western Pennsylvania is aiming to enable more biopharmaceutical firms to translate cutting-edge science and research into practical applications.

Beyond CRISPR: Next-Gen Gene Editing with TARGATT, Mad7, Base Editing

Consider several groundbreaking gene editing technologies and gain insights into their transformative applications in genetic engineering and therapeutic development.

From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

Ready-To-Use Nested Vial In Tub: New Design And Packaging Configuration

With the increasing demand for cell and gene therapies, CZ nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

4 Things To Consider In Pharmaceutical Labeling

Pharmaceutical labeling demands precision. Ensure accuracy and efficiency in your process, from robust control systems to diverse printing options and comprehensive qualifications.

FEATURED EDITORIAL

Stop Hiring Now! Stay Virtual

Robert Discordia, Co-Founder, President and CEO, EQUULUS Therapeutics, knows that to advance early-stage development assets most economically, biotechs should (a) stay within their virtual model, and (b) base that outsourcing strategy on initial business objectives. Here are his dos and don'ts.

Distributed Cell Therapy Manufacturing Trade-Offs You Should Know About

For all its patient-centered benefits, producing personalized medicine at the point of care has pitfalls that are worth careful consideration.

SPONSOR

Explore how shifting demand for oligos and peptides is driving outsourcing relationships and innovation in CDMO partnerships. Join our next Outsourced Pharma Live as we cover best practices for outsourcing these specialized therapeutics, focusing on capacity, regulatory challenges, and technology transfer. Register today to learn about the unique challenges and opportunities in scaling production for these complex molecules.

SOLUTIONS

Our Platform Optimized For Scale-Up And Transfer

Accelerate your journey from R&D to cGMP-grade LVV production with POSTmark, reaching scalable, high-quality outcomes in just 6–9 months with greater efficiency and reduced risk.

How Do We Help Your Team Overcome Challenges?

By outsourcing our flexible, scalable AAV platform — yon can leverage DoE methodology, regulatory expertise, and an experienced CMC team for cost-effective, high-quality results.

mAb/Recombinant Protein Lot Release Package

Our comprehensive testing package includes assays to detect adventitious agents, assess general characteristics, and ensure compliance with cGMP regulations.

Advancing CRISPR-Based Therapeutic Development

A CDMO that manufactures nucleases at research and cGMP grades can eliminate the need for custom manufacturing runs, simplify the transition to clinical application, and reduce regulatory paperwork.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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