Newsletter | June 17, 2025

06.17.25 -- What Biotechs Learn From Takeda's Internal Manufacturing Competition

SPONSOR

Webinar: UpTempo℠ Plasmid Platform: Seamless Transitions from Bench to Cell and Gene Therapy Applications

Discover how Catalent’s UpTempo℠ Plasmid Platform is transforming plasmid DNA manufacturing for cell and gene therapies. Join this expert-led webinar to learn how this innovative solution accelerates development timelines, enhances yields, and simplifies supply chains. Gain valuable insights into overcoming common manufacturing challenges and the benefits of a streamlined, one-stop approach. Click here to learn more.

INDUSTRY INSIGHTS

Safeguarding Cell Therapy Cryopreservation: Primary Containers

Review different aspects of container selection from the perspective of cryopreservation that may be overlooked but are critical for the quality of cell therapy drug products.

Critical Supply Strategies For CROs

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

The Hidden Costs Of Cutting Corners

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.

FEATURED EDITORIAL

What Biotechs Learn From Takeda's Internal Manufacturing Competition

Biotechs can learn about outsourcing facility selection from a pharma company like Takeda, who evaluates both internal and external locations to place its development and manufacturing projects. This is part two of Chief Editor Louis Garguilo's discussion with Takeda Linz's Roland Fabris.

External Partners Are Relational And Technical

Jumai Abioye, Founder and CEO, Pan Access Innovations Inc. provides opening comments on CMC needs and gaining support from your CDMOs.

INDUSTRY INSIGHTS CONTINUED

Who's In Charge? How To Ensure Effective Trial Oversight, Leadership

Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

Label-Free Whole-Body Pharmacokinetics

This approach enables tissue-level analysis, delivering insights into efficacy at the site of action, uncovering potential safety concerns, and supporting smarter clinical candidate selection.

Super Short Activated CAR-T Process

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

Optimization Of rAAV Production Using An In-House Suspension

Boost rAAV yields and quality while reducing costs with the HEK293 cell line and scalable, optimized manufacturing platform for gene therapy.

Enabling The Future Of Gene Therapy With Decentralized Manufacturing

Learn how scalable innovation is transforming viral vector production and driving broader, more equitable access to advanced gene therapies.

Efficient Mammalian Cell Engineering For Difficult Protein Expression

By leveraging cells equipped with an existing landing pad, explore how inducible expression can be efficiently achieved within just four to six weeks after donor plasmid creation.

How BioServices Centers In France Enable Efficiency And Scalability

To support the growing demands of the ATMP industry, it's essential to leverage integrated biostorage, sample management, and regulatory solutions, and we are committed to enhancing these capabilities.

Spotlight On Excell-Ence: Quality Assurance Team

The QA team at a cell therapy CDMO ensures all aspects of development and manufacturing meet the highest standards of quality, safety, and regulatory compliance.

Wrap-Around Labeler In Personalized Medicine

Consider this reliable solution for labeling small batches of medical products, including vials, syringes, and cartridges, that fully automatic machines struggle to handle for your next project.

SPONSOR

We’re excited to announce that the 14th HPAPI: Highly Potent Drug Manufacturing Summit returns in August – this time free for drug developers! Join for: 80% Brand-New Speaker Faculty; 54% Big Pharma Representation; 7+ Hours of Networking with experts from Pfizer, Bristol Myers Squibb, Johnson & Johnson, Biogen, Teva Pharmaceuticals, Relay Therapeutics, and more! Don't miss this opportunity - learn more.

SOLUTIONS

Expediate Gene Editing For Patients

Investigate a powerful suite of proprietary gene editing technology to accelerate the development of life-changing and curative therapies.

Capacity Update April 2025: Cell & Gene Therapy

Witness how NYBCe and CCS are transforming cell and gene therapy development with end-to-end CDMO solutions, advanced logistics, and a growing innovation hub in Louisville.

Microbial Fermentation Services

With experience in microbial fermentation and a commitment to scientific precision, we have developed a solid foundation that supports effective results for our partners.

CDMO Capacity Update April 2025: CGT

Director of Commercial Development, Serat Ali, describes FDB's Advanced Therapy capabilities, discusses their global facilities network, and provides a capacity update.

AAV cGMP Manufacturing Located In San Sebastian, Spain

Manufacturing services are powered by the advanced Pro10™ platform, which has produced over 1000 successful batches of high-quality vectors crucial for gene therapy research.

Gene Therapy Innovation From Platform To Process

Our advanced, modular AAV manufacturing platform is continuously evolving to adapt to developer needs and the ever-changing regulatory landscape.

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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