Newsletter | September 26, 2024

09.26.24 -- Understanding Excipient-Influenced mAb Dynamics At The Atomic Level

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Mabion Capacity Update July 2024: Fill/Finish

Mabion, a biologics CDMO with end-to-end services focusing on recombinant proteins development and production, showcases new depyrogenation, fill finish vial capabilities, and CMC analytical proficiencies.

FEATURED EDITORIAL

NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level

Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.

Medicinal Chemist, Meet Your CDMO

Ben Stevens of GSK documents his career, and highlights a stage in outsourcing we often overlook   key interactions between med-chem scientists and research biologists, and contract development and manufacturing providers (CDMOs).

One-Stop-Shop Outsourcing Vs. Boutique CDMOs

Our moderator and panelists get into quite an open discussion about whether to select bigger, multi-service providers, or more focused external partners known as best-in-class in specific services he need.

INDUSTRY INSIGHTS

A Best Practice Guide For Laboratory Services In Oncology Trials

Discover how customizable laboratory services are revolutionizing oncology trials by enabling precision medicine and enhancing patient outcomes through flexible, innovative trial designs.

Downstream Strategies To Accelerate Preclinical Development Timelines

As recombinant protein-based products accelerate toward IND, reliable process development methods are critical to meet demand. Review case studies to learn how expedited timelines can be achieved.

Orphan Drug Aseptic Fill Finish, Clinical Trials, And The Impact Of Advocacy

Orphan drug development is a journey marked by challenges at every step. From patient recruitment to aseptic fill finish, overcoming hurdles is critical for bringing life-saving treatments to market.

Creating Accurate, Efficient, And Effective CDMO Project Proposals

To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

Mastering Complexity: Strategies For CMC Development And Optimization

Implementing a strategic approach to optimize your platform can establish a solid foundation for the efficient, reliable, and successful manufacturing of biopharmaceutical products.

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.

mRNA: How To Build A Custom Program Using CDMO Services

Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas.

Applying Automation To The Manufacture Of Drug Delivery Devices

Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

Master Cell Banks: Laying The Foundation To Final Product Success

By investing in the establishment and maintenance of a high-quality master cell bank, developers can set themselves up for long-term success and ensure supply chain sustainability.

Innovative Analytical Strategies To Address Common Development Challenges

Discover strategies to address challenges occurring during the development of molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Overcoming Inventory Challenges For A Complex, Global Study

Explore how the optimization of Interactive Response Technologies (IRT) settings relieved the burden of managing global supply needs for a CRO customer and clinical sponsor.

Advancing Your API To First Human Dose Trials More Efficiently

Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

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Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

SOLUTIONS

Biomarker Development And Assessment

Whether used for primary or secondary endpoints or in exploratory research, our seasoned scientists provide rigorous and scientifically robust support to ensure the successful application of biomarker assays.

Affinity Chromatography Resin For Purifying Recombinant Proteins

An affinity chromatography resin for purifying recombinant proteins using the self-cleaving Cytiva™ Protein Select™ tag.

Capacity Update July 2024: Large Molecule Development

Review our capabilities in tech transfer, clinical drug substance, and commercial drug substance manufacturing across our manufacturing network in Singapore, Europe, and the US.

Handle Your Drug Product With The Highest Quality And Safety

Explore our fill line capabilities, including vial and syringe handling. Schedule a tour of our DP filling facility in Denmark. Our experienced team is available to discuss your needs.

Parenteral Drug Formulation Development Process

Scaling your drug product from concept to commercial supply requires having the expertise to ask the right questions about your end goals, from the start.

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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