09.03.24 -- What's In Your DMF?

Partner Week is back this October! From 10/21 through 10/25, hear from CDMOs across Fill/Finish, Large Molecule, Small Molecule, Cell & Gene, and our newest addition: ADC. Bring your questions and requirements, skip the small talk, and get right down to the business of finding the best-fit partner for your short- and longer-term drug development needs. Register for free at this link.

Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.

Delve into four articles that dissect the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.

Uncover guiding principles to ensure that your supply chain is future-proof and learn how an agile, flexible approach can help advance your project with reduced costs and delays.

Selecting a CDMO isn't just entering a transactional relationship. You are forming a long-term partnership that can impact the success of your current product and benefit the manufacturing of future products.

CAR T-cell therapies are becoming more precise in targeting cancer cells and overcoming production challenges, positioning them to revolutionize oncology.

Review a method for evaluating the length of poly(A) tails in mRNA which has been developed using RNase enzymes and capillary gel electrophoresis. Direct RNA sequencing is used to confirm the results.

Consider these strategies for meeting quality and regulatory requirements in CGTs that can also help to identify issues early, reduce risks, and prevent delays and rework.

Examine the challenges CGT innovators face and how adhering to GMP requirements from an early stage helps ensure successful downstream applications from early clinical development to commercial phase.

LVV manufacturing processes remain a significant hurdle for sponsors. Examine a cell line packaging and producing platform designed to enhance LVV manufacturing efficiency.

A CDMO that manufactures nucleases at research and cGMP grades can eliminate the need for custom manufacturing runs, simplify the transition to clinical application, and reduce regulatory paperwork.

Learn about a scalable, single-use platform with built-in automation that enables standardized manufacturing workflows for mRNA-LNP drug product production.

As CGTs continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves.

To address the challenges that accompany AAV manufacturing, we use a combination of reductionist and holistic approaches to perform end-to-end optimization for its platform.