Newsletter | April 18, 2024

04.18.24 -- Process Development: Stuck In The Middle With You

SPONSOR

The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility. Learn more about ICH Q14 and how proactive application can save time and cost over the method development life cycle.

FEATURED EDITORIAL

Process Development: Stuck In The Middle With You

There is pressure to accelerate programs out of research, and into development. Then, despite the complexity of new drugs, therapies and technologies, process development chemists are asked to quick-step to clinical grade, and commercial-ready material. For their part, CDMOs need to react to it all.

Navigating Grades And Sources Of Materials In Drug Manufacturing

From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.

INDUSTRY INSIGHTS

Overcoming Formulation Challenges For mRNA, High-Concentration Proteins

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

What Does The Future Have In Store For Nucleic Acid-Based Therapies?

While breakthroughs with mRNA vaccines have ignited renewed interest in nucleic acid medicines, the road to wide adoption will present many challenges. Learn more about the future of these therapeutics.

Considerations For Successful Upstream Manufacturing Process Scale-Up

A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process.

Ensure Speed And Success With Your Drug Delivery Project

Hear from experienced professionals in drug delivery on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Optimizing The Formulation For A Monoclonal Antibody

An emerging biotech company sought help developing a formulation for a monoclonal antibody. Review the solution that delivered an optimized formulation within an aggressive timeline and budget.

Managing Outsourcing For Complex Formulations

Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown.

SPONSOR

Latest Advances In Applied Nanotechnology For Formulating Better Amorphous Solid Dispersions and Monoclonal Antibodies 

Join us on May 1st to learn the latest in nanotechnology. Recent developments in leading nanotechnologies are enabling new formulation possibilities for more products, providing a better patient experience and stronger differentiation for biopharma innovators. Discover new data on nanotechnology and how to tackle drug loading and pill burden issues associated with amorphous solid dispersion formulations. Click here to learn more.

SOLUTIONS

Supply Chain Management

Discover how key partnerships can help provide clients insight into potential product degradation inflicted during the final product distribution process and provide transport validation support.

Providing A De-Risked And Streamlined Development Pathway

At Abzena, the leading CDMO + CRO for complex biologics and bioconjugates, our focus is on providing a de-risked and streamlined development pathway for our customers.

Biopharma Resilience: Bionova Scientific Talks Capacity, Speed, And Agility

Learn how a CDMO can offer biopharma companies the flexible capacity they need to meet the growing needs for medicines today and in the future.

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.

Connect With Outsourced Pharma: