04.17.25 -- What If The Trump Tariff Strategy Works?

Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

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, identifying CDMOs that might be impacted by key events affecting their clients.

The design of bispecific antibodies requires a comprehensive assessment that takes the following aspects into account: half-life, mechanism of action, and manufacturing challenges.

Formulation scientist Dr. Shehaab Savliwala transforms complex pharmaceutical challenges into breakthroughs, leveraging expertise in nanoparticle formulations and innovative drug delivery.

Uncover a comprehensive framework for conducting robust comparability studies that ensure biosimilars meet stringent standards for safety, efficacy, and quality.

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

For emerging biotechs looking to refine their development processes and boost their chances of commercial success, exploring these partnership opportunities could prove invaluable.

Early collaboration with a clinical supply manager can help proactively negotiate potential pitfalls. Learn efficient resupply practices and execute successful supply chain strategies.

We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why we're bringing together 31 CDMOs for our Outsourced Pharma Capacity Update Partners Week — a chance to explore their latest capabilities and available capacity, all from the convenience of your screen. Learn more about our sessions grouped by modality to join us to find the right partner for your project.

With our high-productivity and single-use technology, we provide you with a continuous manufacturing approach with easy-to-modulate capacity and efficient end-to-end sustainable processes.

Consider our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.

Over the past 20 years, we have completed more than 175 successful projects around the globe, showcasing our commitment to quality and customer satisfaction.

Learning from decades in the CDMO sector, INCOG has been purpose-built to provide better solutions for the global injectable drug product sector.

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches.