Newsletter | August 12, 2024

08.12.24 -- You Want Success With CDMOs? Think In Threes

SPONSOR

Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon

As the U.S. government works to pass the BIOSECURE Act, which aims to the protect the IP of U.S. pharma companies, the EU is simultaneously seeking to increase innovation across the European biomanufacturing industry. Amid these cultural shifts, sponsors are considering the best global partnerships for their goals.

FEATURED EDITORIAL

You Want Success With CDMOs? Think In Threes

Twenty-eight years at Gilead, but Reza Oliyai’s new pursuit is no mere second act. He establish Oliyai Consulting Corporation, focused on Chemistry and Manufacturing Controls (CMC), to teach others his series of guiding "triads" to apply to all activities related to drug development and manufacturing outsourcing.

More Case Studies: Managing Change In Vaccine Production

Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.

INDUSTRY INSIGHTS

Accelerating Biologics Development: Flexible And Fast DNA-To-IND Programs

Gain expert insights on how tailored approaches and innovative technologies enable fast and flexible workflows, ultimately supporting rapid therapeutic breakthroughs.

In Vitro Assessment Of Fc Functional Activity

By employing a comprehensive panel of assays to characterize the Fc-mediated activity of antibodies, Fc fusion proteins, or ADCs, researchers can streamline development and expedite the path to clinic.

Understanding Process Development Of ADCs In Early Phase Clinical Trials

Examine a platform process that is emerging as a simplified solution for ADC manufacturing, offering efficient process development, purification techniques, and optimization strategies.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the findings of a new wearable injector trial, including its positive impact on patient experience and the benefits of wearable injectors for chronic disease management.

The Critical Role Of Comparative Analytical Assessments

Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

Precision Volume Accounting In Fed-Batch Cultures

Are you searching for a better way to calculate growth rate? Explore a new approach that performs the rate calculations using a simple method to correct for volume changes.

SOLUTIONS

Laboratory Services

Singota Solutions has a variety of equipment and instrumentation available for formulation, product development, microbiology, testing and analytical activities. Select equipment, methods and instrumentation are validated and/or GMP compliant.

Drug Characterization And Release Testing Services

Leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.

European Center Of Excellence For Clinical Biologics

Explore how our proven expertise and simplified execution with development, filling, and analytical under one roof ensure safe, efficacious products reach patients in need.

Samsung Biologics Capacity Update May 2024: Large Molecule Development

The therapeutic promise of biologicals has fundamentally changed health care. Samsung Biologics is committed to helping drug developers bring these promising new therapeutics to patients.

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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