07.25.24 -- DMFs And CDMOs: Surprises At The Regulatory Intersection

Save the date for August 5th for Transforming Safety in CDMO Operations: A Customer Centric Model for Patients and Employees. This webinar will highlight the unique infrastructure FDB has built around safety operations and quality, with a focus on their new product introduction process with respect to risk assessment. Click here to learn more.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Discover how building a product development program with a long-term vision and adopting a holistic PPQ and CPV strategy from the outset are now crucial.

The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.

Liposome technology is an effective drug delivery tool but still presents difficulties. Learn about how developers are meeting these challenges and the opportunities for advancement to maximize liposome usefulness.

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

Depending on the protein or peptide of interest for your therapeutic and your manufacturing goals, there are a number of different manufacturing approaches, each of which can be advantageous.

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges that clients face.

Delve into the intricacies of creating robust cell lines for monoclonal antibody production, as well as process development principles key to achieving therapeutic success.

Learn how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.

Explore the benefits of the XS Pichia 2.0, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

Establish productive, robust, scalable, and efficient cGMP processes more quickly and easily with the XS Technologies platform which offers a toolbox of system components.

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.

With NxGen technology on the NanoAssemblr Blaze, important studies can be conducted efficiently with a process that mirrors a clinical-scale implementation.

Explore labeling and re-labeling, secondary packaging, and kitting support for Preclinical Studies, Clinical Trials, Merger & Acquisition Activities, and Blinded Studies.

Our globally integrated drug product and finished goods services offer agile and flexible solutions for clinical to commercial products.