Newsletter | July 23, 2020

07.23.20 -- Advancements Of Biologics Development And Manufacturing, Including PDNA

Manufacture pDNA Without Sacrificing Quality Or Budget

If plasmid DNA (pDNA) is integral to your biopharmaceutical production process, are you integrating it as effectively as possible? Find out how Cytograde™ pDNA helps manufacturers realize cost-efficacy — as well as manage risk.

3 Key Considerations For Phase-Appropriate GMPs

Because regulatory requirements and GMP expectations increase as product development proceeds, many biopharmaceutical manufacturers wait until late stages to make Good Manufacturing Practices (GMP) a priority. Find out how a new approach to phase-appropriate GMPs can help manufacturers navigate today's regulatory landscape with confidence.

Strategic Partnership Delivers Innovation, Efficiency In Biotech Training

Biotechnology manufacturing training represents a large, often challenging investment. Developing and implementing an effective training curriculum takes months or years, diverting valuable time and resources away from other projects. Learn how a CDMO partnered with an academic institution to develop a methodology that created a fully-functional biotech floor team in under 3 months.

Phase-Appropriate GMPs: A Regulatory Roadmap

This webinar focuses on current best practices for mapping the regulatory framework during R&D, investigational phases, and commercial manufacturing. Taking a proactive approach to exploring what control strategies are expected, and subsequently required, provides a streamlined development approach ensuring the safety and quality of the product.

R&D Quality As The Foundation For Product Quality

This webinar discusses control of quality during the various stages of R&D while still maintaining the flexibility necessary for research. There must be dynamic balancing of expectations for quality with the needs of the scientists to understand and characterize the material being produced particularly in R&D.