04.19.24 -- Developing & Implementing A Continuous Bioprocess Control Strategy

Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this love match between long oligos and CRISPR works.

Once a company has demonstrated proof of concept, it is critical to consider process elements like scalability, sourcing raw materials, and GMP adherence.

Learn about stereo microscopes that combine high resolution and depth of field to provide a superior 3D perception of samples.

Explore key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.

The key to navigating the biologic development journey lies in CMC. By analyzing and characterizing the drug's properties, CMC teams ensure a smooth path from bench to patient care.

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Improve your downstream purification process and utilize design of experiments (DOE) to help in selecting appropriate chromatographic techniques and account for variation among mAbs.

Explore a description of research grade and process development productions of rAAV6, both based on transient transfection of serum-free cells grown in suspension.

Develop and use QC assays that facilitate both product and process understanding and control.

Late-stage clinical trial failures usually result in exposure with regard to capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment?

Companies aiming to accelerate biomanufacturing operations and use resources efficiently need access to technologies that can safely and efficiently complete their workflow from idea to injection.

Current advances in cell, gene, and tissue therapies require a rethinking of how — and where — cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems.

Prior to making critical capacity decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best strategy for its manufacturing.