Are you looking for the right contract development and manufacturing organization (CDMO) to develop and manufacture your high potency active pharmaceutical ingredients (HPAPIs)? Or have you been unsure about the CDMO you’re currently working with?
In this free webinar, the featured speaker will explore the critical factors that should be considered when identifying and evaluating CDMOs for HPAPI for development and manufacturing. Other topics of discussion include the value of different types of containment technology, the significance of protocol during equipment changeovers and the advantages of certain cleaning strategies. Additionally, the speaker will review the important role of quality assurance in HPAPI manufacturing and delve into the questions you should ask a CDMO about their capabilities and corporate commitment to processing these complex APIs.
Attendees of this webinar will know what answers to look for and be prepared to spot the red flags that could add major risk to their critical projects.
Brian P. Haney, PhD, Director of Technical Operations, AMRI
Brian P. Haney received his Bachelor of Science in Chemistry from Allegheny College in Meadville, PA and then went on to receive a PhD in Chemistry from the University of Pittsburgh. His thesis work was done with Dr. Dennis Curran and centered on tandem radical cyclizations for the synthesis of complex natural products. Brian joined AMRI in 2000 as a process chemist and rose through the department to become a group leader. In 2008, he moved to the Rensselaer, NY facility as a manufacturing manager focusing on HPAPI programs. Brian spent eight years in manufacturing management as the director of manufacturing with responsibilities for commercial and clinical API manufacturing, production scheduling, HPAPI leadership, controlled substances, new business evaluation and SOP generation. In 2016, Brian joined AMRI’s global technical operations team with responsibility for project management, commercial technical support, new business evaluation and product rationalization across an API network of nine international sites. Brian is currently based at the API manufacturing facility in Rensselaer, NY and focuses on the API division for chemical process optimization, cost savings initiatives and project management.
Who Should Attend?
This webinar will appeal to senior-level professionals from pharmaceutical and biotechnology companies and research/academic institutions.
- Chemistry/Professional Chemistry/Medicinal Chemistry
- Analytical Chemistry
- API/HPAPI Development Scientists
- API/HPAPI Manufacturing
- Chemical Engineering
- Manufacturing Engineering
- EHS Specialists
- Processes Safety Scientists
- Analytical R&D
- Chief Scientific Officers
- Research Scientists
What You Will Learn
Attendees will learn about:
- Key considerations for identifying and evaluating CDMOs for HPAPI development and manufacturing
- Different types of containment technology
- Significance of protocol during equipment changeovers
- Advantage of certain cleaning strategies
- Role of quality assurance in HPAPI development and manufacturing
- Questions to ask a CDMO with regards to processing complex APIs
- Red flags that could add major risk to critical projects
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product.