Newsletter | October 29, 2024

10.29.24 -- Keys To Successful CMC Source Document Preparation For Cell & Gene Therapies

FEATURED EDITORIAL

Keys To Successful CMC Source Document Preparation For Cell & Gene Therapies

Chemistry, manufacturing, and controls (CMC) source documents are the foundation for module 3 of a cell/gene therapy FDA regulatory submission.

INDUSTRY INSIGHTS

Design Of Experiments Approach To Enabling Studies For Process Validation

A recent project applied process improvement methodology to the process validation step that ultimately provided not only an optimized, robust process but also an economic advantage.

Considerations In Depth Filter Scale-Up

Explore study findings aiming to assist process development scientists and engineers in understanding the structure of depth filter capsules, identifying key parameters for development, and more.

Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up

Process data are used in many ways throughout the process development and production phases. Here, we outline how connectivity and comprehensive automation ease tech transfer and scale-up.

Recent Innovations And Enhancements To Pharmaceutical Spray Drying

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

Accelerated API Manufacturing: Combining All Process Development Stages

During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

MOST POPULAR NEWS

Tevogen Bio's Effort In Artificial Intelligence, Tevogen AI, Joins Microsoft For Startups

UCSF Receives Major Award To Speed Drug Development With AI

New Method For Producing Innovative 3D Molecules

Dundee 'Cut And Sew' Process Can Accelerate Drug Design

Sanofi And Orano Join Forces To Develop Next-Generation Radioligand Medicines

Nido Bio Announces ODD For Lead Clinical Candidate To Treat Spinal & Bulbar Muscular Atrophy

Recursion & Google Cloud Announce Expansion Of Partnership

Avacta And Tempus Enter Strategic Collaboration To Advance AI-Driven Drug Development In Oncology

Amneal Receives U.S. FDA Approval Of NDA For Pyridostigmine Bromide Extended-Release Tablets

Bioptimus & Proscia Collaborate To Accelerate AI Innovation

FDA Accepts NDA & Grants Priority Review For TLX101-CDx (Pixclara®)

SOLUTIONS

PBPK Predictive Modeling Services

An Unparalleled Window Into IBD Immune Response

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