Highly potent drugs are becoming increasingly prevalent in the drug development pipeline. The focus on oncology, rare diseases and highly targeted therapies is growing. While highly potent compounds have benefits in treating certain medical conditions, companies with promising high potency active pharmaceutical ingredients (HPAPIs) can face significant challenges in developing and bringing these innovative medicines to market. Key challenges revolve around containment systems that ensure workers and the environment are protective along with demonstrable and adequate controls to mitigate cross-contamination risks in a multi-purpose environment.
Some drug sponsors/developers do not always understand what potency implies or what it means to their proposed processes at a selected CDMO site. They may not know how much or what type of containment is needed and its impact to the development, scale-up, and/or commercial manufacturing processes.
This webinar will examine:
- Different levels of containment for HPAPIs
- Scale specific containment of OSD manufacturing processes
- Containment challenges for common OSD unit processes
- Misconceptions about containment systems for potent products
- Advantages and disadvantages of hard-sided vs. flexible single-use containment systems at a CDMO site
- Impacts of using containment for product development activities
- Regulatory requirements for contained equipment and facilities in a multi-purpose environment
Metrics Contract Services has developed and implemented a robust new product introduction (NPI) process that utilizes a broad cross-functional approach that brings together EHS, QA, Product Development and Operations to drive consistency and thoroughness in choosing the optimum containment systems that protect people and prevent cross contamination when introducing an HPAPI onsite.
Do you have a containment challenge involving HPAPIs? Are you wondering how your potent compound will be contained at a contractor site and its impacts on your project moving forward?
Join this engaging webinar as presenters explore containment issues and provide examples and information from years of real-world experience in handling high potency products.
Key Learning Objectives
- Levels of containment for HPAPIs and common misconceptions about containment for potent products.
- Scale specific containment approaches.
- Advantages and disadvantages of certain containment systems at a CDMO site
- Impacts of containment in product development
- Regulatory requirements for containment in a multi-purpose facility
Target Audience
- Pharmaceutical Development Groups,
- Operations Personnel,
- Facility Personnel,
- Quality Engineering,
- Quality Assurance Teams,
- Environmental/Safety/Health Teams,
- Senior Management.
