Newsletter | November 12, 2024

11.12.24 -- How Cidara Got Its Molecule Back

FOCUS ON OUTSOURCING

How Cidara Got Its Molecule Back

In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.

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.

Advancements In Microbial Manufacturing Of Biopharmaceuticals

Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

The Right Scale At The Right Time To Accelerate Your Market Supply

Explore challenges in today’s changing market and solutions to help successfully develop and manufacture lifesaving products.

Expanding The OSD Toolbox

This session is designed to provide practical solutions for enhancing bioavailability and scalability in pharmaceutical formulations.

Considerations For Functional Viral Vector Titration By Flow Chemistry

Accurately quantifying viral titers is a challenge in the manufacturing of viral vectors. Gain valuable insights into improving the robustness and reproducibility of viral vector functional titers.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Explore the 3 phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

End-To-End Analytical Solutions For Biologic Development

Partner with Mabion for comprehensive, state-of-the-art analytical services that ensure quality, safety, and regulatory compliance throughout every stage of your biologic drug’s lifecycle.

From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

Successfully Producing Insoluble Proteins Using Inclusion Bodies

Review the pros and cons of soluble and insoluble processes, experiences with isolating, solubilizing, and properly re-folding, and strategies and innovation to improve insoluble processes.

Regulatory Considerations For First-Time Drug Developers

Navigate the path from concept to clinical reality by partnering with a CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward.

Robust Off-Gas Analyzers For High-Throughput Bioreactor Facilities

Learn about an off-gas analysis system for bioreactors that can provide slightly faster response times than commercially available analyzers.

Identify The Production Strategy Best Suited For Your Protein Or Peptide

Depending on the protein or peptide of interest for your therapeutic and your manufacturing goals, there are a number of different manufacturing approaches, each of which can be advantageous.

Why Your Biotech CMO Is Expanding In Combination Product And Fill/Finish

Argonaut Manufacturing Services is doubling down on growth, expanding its capabilities in combination product and drug-fill/finish manufacturing to meet the evolving needs of the biotech industry.

The Journey From Initial Method Transfer To Successful Lot Release

View the webinar and learn how efficient project management and optimized communication are cornerstones of a successful transfer process.

OUTSOURCING SOLUTIONS

Biologics Analytical Services - Catalent

Level Up Your Nucleic Acid-Based Therapy - Resilience US, Inc.

The Advantages Of Raw Material eData Exchange - MilliporeSigma

SUREmAb - Monoclonal Antibody Development, The Way It's Meant To Be - KBI Biopharma

ATON Bio Capacity Update July 2024: Large Molecule Development - Aton Biotech

Ramp Up Your AAV Production With The Xcite AAV Platform Technology - Lonza

Gene Editing - ElevateBio

Our Approach: Viral Vectors Made Accessible - VintaBio

NanoImprove Your Small And Large Molecule Formulations - Nanoform

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