03.06.24 -- How To Speed Up Time To Market With CMC Knowledge Management

Innovations in PAT are helping to provide comprehensive, earlier capabilities. Learn about an automated sampling system and its utilization in perfusion cell culture for upstream process development.

What are the key factors to consider when choosing the right microscope camera for your system and experimental needs?

Explore the factors considered when determining the endotoxin limit for each newly developed injectable drug product, how this affects pediatric patients, and the endotoxin tests that are performed.

The result of regulatory compliance with quality standards is binary, but the processes employed to get there do not need to be rigid, inefficient, or expensive. Learn how innovation drives efficiencies.

Recombinant adeno‐associated viruses (rAAV) are among the most promising vectors for long‐term gene transduction. In this study we explore chromatography workflow solutions to purify rAAV8.

Combine deep industry expertise with innovative solutions and technologies, comprehensive service offerings, and a uniquely customized, client-centered approach.

Explore the application of in vitro flux assays to nanoparticles, with data on how the in vitro permeability apparatus can characterize the membrane flux performance of an API formulated as a nanosuspension.

PMs must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of critical quality attributes (CQAs), and performing design verification testing.

Looking to improve the resilience of your supply chain? Who isn’t? According to a report by Bain & Company, improving supply chain resilience will require redundancy, adaptability, and predictability.

Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.

To find the plasmid manufacturer with the appropriate knowledge and experience to manufacture your plasmid with quality and efficiency, you’ll need to recognize the offerings of a seasoned supplier.

Polishing chromatography describes the removal of minute amounts of impurities in the final phase of biopharmaceutical manufacturing. Explore considerations in developing your polishing steps.

Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.