01.31.24 -- Building AAV Manufacturing Capacity For Large Patient Diseases

An alternative to traditional polyethylene bags is offering cell and gene therapy manufactures a solution to contamination concerns.

Examine these tips to help you build the right team, set a realistic timeline, and generate the right data to ensure you file correctly the first time.

Characterizing Fab and Fc-Fusion proteins and developing robust manufacturing processes can help usher them to market and provide new treatment options for diseases that are currently challenging to treat.

Explore a case study using a specific HCP immunoassay and advanced orthogonal antibody affinity extraction and mass spectrometry methods for assay qualification.

A great deal is known about how pH affects aqueous critical cleaning. The first step is for you to identify the residue that needs to be removed and then determine the optimal pH range that will remove it.

Learn how to navigate the wide range of "quality claims" and find a CDMO partner that is committed to a culture of quality, placing safety and product excellence at the core of their operations.

The future of conjugation and PEGylation in biologics is promising, and understanding the key focus areas for PEGylated proteins can help to enhance drug efficacy and reduce immunogenicity.

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.

Realizing the potential of mRNA requires focus on key areas and strategies that could help alleviate the bottlenecks in this growing market segment.

Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Demands for flexible, scalable, cost-effective manufacturing are prompting cell and gene therapy manufacturers and CDMOs to implement single-use technology for manufacturing their therapies.