Newsletter | June 17, 2024

06.17.24 -- Medicinal Chemist, Meet Your CDMO

SPONSOR

Webinar: Key Elements of Process and Analytical Development to Support Biologics Tech Transfer

In this webinar our expert panel discusses the intricacies of technology transfer, drawing from real-life case studies. Investigate critical components for success, risk assessment, and effective mitigation strategies. Learn how to optimize your timeline and enhance efficiency in your transfer processes. Click here to learn more.

FEATURED EDITORIAL

Medicinal Chemist, Meet Your CDMO

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

7 Steps To Accelerate Biopharma Manufacturing Processes

Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.

INDUSTRY INSIGHTS

Characterizing Injection Factors And Their Impact On System Function

The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.

A Flexible Approach To CMC For Fab And Fc-Fusion Development Programs

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are challenging to treat.

Building A Fully Single-Use Process: Protein A Membrane Devices

Learn how a disposable upstream and downstream platform process in antibody production can increase timelines, enhance scalability, and reduce risk in biologics manufacturing.

How mRNA Technology Engineers Next-Generation Antibodies

Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery.

Putting The “Process” Into Process Characterization

Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Examine a platform approach to Process Characterization that has been proven effective in supporting the approval of several products.

Bulk Filling Of Drug Substance | Accurate Aliquoting

Bulk filling drug substances in traditional facilities is often a lengthy, manual process where operators are relied upon to achieve accurate filling. This method increases process risk through errors that can compromise accuracy.

SPONSOR

Webinar: CDMO Perspectives in Biotech Drug Development 

Join us on June 24th and learn characteristics of CDMOs that work best with early-stage, small biotech projects and a framework to manage them for success! Content in this webinar will explore this realm from the perspectives of the various stakeholders, history lessons, and future considerations. Click here to learn more.

SOLUTIONS

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

Learn how our parallel development service works seamlessly with our existing antibody capabilities, helping to accelerate your ADC program and reach market faster.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Conquer Complexities With Advanced Mass Spectrometry

Advanced analytical technologies offer insights into the structural characterization and quantitation of biotherapeutics, helping to advance projects to market on time.

Potency Assay Development - Creating Potential Together

It is necessary to achieve a well-designed and developed potency assay as it is the only analytical technique that can demonstrate the biological mechanism of action and the link to clinical efficacy.

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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