Newsletter | April 4, 2024

04.04.24 -- Beyond (And Better Than) mRNA: T Cell Vaccines

SPONSOR

Four Steps To Identifying The CDMO Proposal Worth Signing

Transparency and communication are essential to the success of a manufacturing partnership. If a CDMO is unwilling to have frank conversations during the proposal phase, that’s likely a red flag. The right partner’s team will help you make educated choices while ensuring quality, reasonable costs, and timeline efficiency.

FEATURED EDITORIAL

Beyond (And Better Than) mRNA: T Cell Vaccines

During an extraordinary discussion with a historic biotech entrepreneur, he matter-of-factly interjects, “We’re leaving mRNA vaccines in the dust and moving onto a different approach to vaccines.” That ‘dust-generating’ approach is a proprietary T cell-based platform. And it has COVID and many other implications.

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate. This article shares how science-based criticality levels were derived, the meaning of each level, and how they can be used.

INDUSTRY INSIGHTS

Microbial Expression System For Efficient Production Of Therapeutic Proteins

The combination of unique and proven plasmids, fast process development, and automated downstream analysis ensures rapid progression from gene to optimized, high-titer fermentation process.

Selecting The Right pDNA Supplier: 10 Key Factors To Consider

Selecting the right pDNA supplier is a critical decision that can significantly impact the success of your project or research. Consider these 10 key factors to help you make an informed choice.

Clearing MRSA Infections At Low Doses With Potent Rifampicin Derivatives

Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.

ICH Q14 101: Applying AQbD To CMC For Regulatory Success

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

Protein L Affinity Resin Is Ready To Move To Manufacturing

Discover a protein L affinity chromatography resin that is well suited for use in biomanufacturing and offers increased binding capacities compared to other resins.

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

Drug developers must successfully navigate the path to market under the growing pressure of regulation and competition and while carefully managing technical and financial risk.

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Qualification’s reduced set of testing requirements aims to demonstrate a method is suitable for its intended purpose, but it typically is not as robust as method validation.

NEW PODCAST EPISODE

Funding Alzheimer's Tx Dev with ADDF's Karen Harris

We've really been looking forward to dropping this episode with Karen Harris, CFO and Head of Mission-Related Investing at the Alzheimer's Drug Discovery Foundation. While the markets have warmed a bit since we recorded this episode of the Business of Biotech, Karen's thoughtful perspective on the sometimes tumultuous Alzheimer's therapeutics space is valuable to any drug developer working in the cognitive medicines arena. Tune in!

SOLUTIONS

Analytical Assay Development & Qualification

By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis or downstream purification by analyzing protein products.

Live Biotherapeutics And Next Gen Manufacturing

With services to develop and scale up Probiotics, Postbiotics, and Microbial Therapeutics, explore how Sacco System’s capabilities can help take your drug product to market safely and efficiently.

Trusted End-To-End CDMO Partner For Your Journey

Working with the right CDMO is vital for successful drug lifecycle management. We now serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access to life-saving biologics.

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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