Newsletter | April 15, 2024

04.15.24 -- Shocking! Biotech Facilities Don't Maintain Themselves

SPONSOR

Introducing the inaugural Cell & Gene Therapy Pricing & Reimbursement Summit. Biotech, pharma, physicians, healthcare providers, and regulatory and government agencies will unite to address key issues such as the impact of regulatory acts, implementing pricing models, and collaborating on enhanced reimbursement strategies, aiming to expedite the availability of these advanced therapies to patients. Register now

FEATURED EDITORIAL

Shocking! Biotech Facilities Don't Maintain Themselves

Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.

Understanding Critical Quality Attributes (CQA) Impact On Variability

There is a need to understand the target product profile and what the product is. What do you expect it to be? What is your proposed mechanism of action and how do you intend to monitor it?

INDUSTRY INSIGHTS

FDA Recommendations For Gene Therapy For Primary Mitochondrial Diseases

Review this collection of strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

Create The Correct Checklist To Land The Best CDMO

Discover how to construct an agreement between partners that favors fluid communication and alignment of business objectives — crucial for a fruitful CDMO relationship to diminish risk for both.

A Robust, Scalable Platform Process For AAV6 Production And Purification

Explore a description of research grade and process development productions of rAAV6, both based on transient transfection of serum-free cells grown in suspension.

Optimizing Scale-Up Of AAV Gene Therapy In Upstream Processing

Uncover more details on how to achieve a 2000L scale-up and studies that have been optimized through process characterization and experimental approaches to better understand key process steps.

Prefillable Syringe Plungers: A Solution For Low Temperature Storage

Examine the impact of 1 mL long glass and polymer-based syringes, as well as 2.25 mL glass syringes, on plunger movement, container closure integrity, and break loose and extrusion force.

SOLUTIONS

Capacity Update Feb. 2024: Cell And Gene

Capacity Update Feb. 2024: Cell And Gene

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