Newsletter | April 16, 2024

04.16.24 -- Why Are Cell-Therapy Outsourcers Unhappy? Investors Know

SPONSOR

Webinar: Safety At The Center – The Synergistic Role Of Drug Safety In Clinical Trial Operations

In drug safety and pharmacovigilance, collaboration isn’t just a buzzword — it’s an essential component that can impact patient safety and the success of your product. Join us in this webinar as we highlight the importance of effective interpersonal leadership in your drug safety program and reveal the operational and financial efficiencies that can result from a collaborative dynamic. Click here to learn more.

FEATURED EDITORIAL

Why Are Cell-Therapy Outsourcers Unhappy? Investors Know

By Louis Garguilo, Chief Editor, Outsourced Pharma

Some private research indicates cell-therapy sponsors aren't happy with outsourcing options. In this part two with a successful investor, we find out how that sentiment might change for the better.

FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions

By Brent Morse and Nate Manley, Dark Horse Consulting

On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

INDUSTRY INSIGHTS

Build A Foundation For Successful Clinical Manufacturing

Article | BioCentriq

Establishing both the QTPP and CQA for your drug at the beginning of the product lifecycle is crucial for a successful GMP manufacturing process.

Next Gen Plasmid Technology: Improve Performance, Safety, Manufacturing

White Paper | Aldevron

Nanoplasmids have paved the way for facilitating a wide range of cell and gene therapeutic applications. Gain an overview of a novel technology and specific benefits.

Optimization Of Nuclease Digestion Unit Operation In A LVV Process

Poster | By James Xin, Nhi Tran, Chyan-Jang Lee, Briana Orlando, Daniel Kennedy, Miranda Williams, Christine Beaudry, Lorenz Ponce, Chase Waxman, et al., ElevateBio

Discover the statistical analysis results based on several DoE studies for the reduction of hcDNA and pDNA levels in a lentiviral vector (LVV) platform process.

Plasmid Engineering To Improve AAV Productivity And Packaging Efficiency

Poster | Lonza

Review how you can significantly increase AAV productivity and packaging efficiency for various AAV serotypes and client-specific genes of interest (GOIs) at the upstream production stage through plasmid engineering approaches.

Accelerating Rare Disease Treatments From Concept To Cure

Webinar | FUJIFILM Diosynth Biotechnologies

Access a thorough investigation that delves into the critical aspects of expediting curative therapies, with a focus on the role that CDMOs can play in this transformative journey.

SOLUTIONS

Single-Use System For Clinical And Commercial Production Of LNPs

Precision NanoSystems

Learn about a scalable, single-use platform with built-in automation and regulatory compliance that enables standardized manufacturing workflows for mRNA-LNP drug product production.

Cell & Gene Therapies – Changing The Healthcare Landscape

Catalent

Experts discuss how cell & gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.

Allegro Ready Filter Sets

Cytiva

Allegro Ready filter sets can be used in wide range of applications, including mAbs, vaccines, plasma, cell, and gene therapies.

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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