Newsletter | April 1, 2025

04.01.25 -- How Biotech Academy In Rome Is Reshaping Workforce Readiness

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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.

FEATURED EDITORIAL

How Biotech Academy In Rome Is Reshaping Workforce Readiness

As the industry continues to evolve, a growing gap in workforce readiness has emerged, driven by insufficient training for both new graduates and experienced professionals. Biotech Academy in Rome's Leonardo Sibilio addresses this challenge.

Remind Me: Why Are We At Biotech War With China?

It’s hard to focus on the issues that precipitated the challenges and proscribed solutions to so much of our supply chain being in China. IP was (and should be) at the center of the discussion.

Counting The Steps To Decentralized Personalized Therapy Manufacturing

AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

INDUSTRY INSIGHTS

Deamidation Drives AAV9 Potency Loss

This study aims to identify the cause of AAV9 potency loss observed during short-term storage at elevated temperatures and long-term refrigeration.

Identifying The Right Analytical Strategy For AAV Production

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

Tech Transfer: 7 Unique Challenges For Advanced Therapeutics

Ensure the success of your tech transfer by addressing these key challenges and optimizing your processes for seamless scalability and compliance.

Supporting Compliance And Reducing Risk In Gene Therapy Logistics

Deliver gene therapies safely and seamlessly by leveraging advanced logistics solutions designed to meet stringent regulatory standards and mitigate risk at every stage.

The Question Of Quality: Digging Into Manufacturing Priorities For Viral Vectors

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Novel Plasmid DNA-Encoded Poly(A) Tails For mRNA Synthesis

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

Effectively Enabling Rare Diseases To Reach Patients

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Overcoming Challenges To The Commercialization Of Lentiviral-Based Therapies

Review the results obtained for our proprietary HEK293T 2G7 suspension cell line for LVV production by transient transfection in serum-free, chemically-defined and animal component-free media.

Achieving Faster Timelines And Cost Savings Through Digital Validation

Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

Our Analytical And Quality Control Strategy For Your Therapies

A comprehensive Quality Risk Analysis and Control Strategy is built on five key pillars, each playing a vital role in ensuring that every final product meets the highest safety and efficacy standards.

SOLUTIONS

Services For Advancing mRNA-LNPs From Bench To Clinic

Discover a one-stop-shop for LNP technologies that provides access to expertise in formulation and analytics for successful outcomes for payload and target applications.

Overcome CRISPR's Limitations With TARGATT™ Gene Knock-In Technology

Build the most relevant cell line for your studies with the ability to insert 20+ kb of DNA site specifically, in single copy, and at efficiencies approaching 100% after selection.

Accelerating Cell Therapy Innovations From Lab To Market

Cell therapies hold immense promise, but navigating the development process can be daunting. A strategic partner can bridge the gap between early-stage innovation and successful commercialization.

One Team, One Roof, One CDMO: RNA Therapies

Our expanded biologics services and technologies encompass the entire RNA development and manufacturing value chain, helping to deliver your innovation to patients seamlessly.

Forge Biologics Capacity Update January 2025: Cell & Gene Therapy

Witness how our 200,000 sq. ft. facility, proprietary technologies, and specialized services provide expert AAV manufacturing to empower developers from discovery to delivery and every step in between.

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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