Course Description:
Requirements for aseptic manufacturing were raised at a time when there was no suitable sterilization method for heat-sensitive pharmaceutical products that could not be autoclaved in the container. By now, aseptic manufacturing for medicines has been specified and standardized. Pharmaceutical and Biopharmaceutical companies have invested to improve aseptic processing technology. Continued growth in the marketplace and high demand with contract manufacturing organizations (CMOs) for aseptic manufacturing is spurring adoption of specific aseptic processing technology.
What key quality considerations, practices, control techniques should drug sponsors and their partner CMOs devote their energy and attention to today?
1 - Evolving regulations and practices
The roots of regulatory requirements for aseptic processing of human medicines trace back to the introduction of sterility requirements in the 1920s. Like many other aspects of manufacturing quality medicines, requirements and best practices continue to evolve--most often in response to new and emerging technologies. We will discuss which, and how.
2- Ongoing challenges and pain points
Aseptic processing is not easy to do. If it were, everyone would do it. So how can you be successful where others have not? We will discuss what makes manufacturing using aseptic processing more challenging than low bio-burden or terminal sterilization methodologies, and explore how to adopt this technology.
3- Emerging trends – best practices
No-one would argue that the invention of the laminar flow cleanroom 50 years ago revolutionized aseptic processing for pharma and biopharma. But the evolution hasn’t stopped there. We see single-use systems and isolation technologies used to reduce risks linked to this manufacturing approach. As new products emerge—such as cell and gene therapies—aseptic practices evolve to meet new manufacturing challenges.
Who should participate:
- Drug manufacturing
- Pharmaceutical manufacturing
- Biologics organizations
- Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Though this course is being made available on USP’s Education site, the course content was developed by Pharmatech Associates, a USP company. USP has not independently reviewed or verified the accuracy of the course content.