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 ensuring that workers and the environment are protected along with demonstrable and adequate controls to mitigate cross-contamination risks.
These challenges are fueling a need to outsource HPAPI processing to a qualified CDMO with the necessary facilities, equipment and skilled personnel to scale-up manufacturing to commercial production. The potent drug pipeline is driven by a mix of traditional big pharma players that may lack the in-house capabilities for handling HPAPIs and smaller start-up virtual companies without proper resources and infrastructure to support their selected drug molecules.
This webinar will examine:
- The definition of HPAPI and how it varies depending on the literature reviewed
- Various steps taken when considering the introduction of a new HPAPI into a facility – such as assessing and properly categorizing the toxicity and potency
- Key containment considerations for handling HPAPIs, including segregation and separation of the HPAPI from other products currently in production
- The appropriate balance between worker safety and cross contamination risk
Metrics 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 evaluating the risks of an HPAPI prior to introducing it onsite.
Do you have a challenge involving HPAPIs? Are you wondering how your potent compound can be assessed to determine what constraints may exist and whether a solution can be achieved to move your project forward?
Register for this engaging webinar as the presenters explore these issues and provide examples and information from years of real-world experience in handling high potency products.
Thomas B. “Brad” Gold, PhD, VP Pharmaceutical Development, Metrics Contract Services
As vice president of pharmaceutical development at Metrics Contract Services, Brad is responsible for overseeing all personnel, facilities and services related to formulation development, potent and cytotoxic products, fast-track development and clinical program support through to commercialization. In addition, Brad is responsible for implementing new technology platforms that include advanced drug delivery methods. He holds a doctorate in pharmaceutics/medicinal chemistry from the University of Kentucky, from which he earned master’s and bachelor’s degrees in chemistry.Message Presenter
Dwight Lewis, Vice President Quality, Metrics Contract Services
As vice president of quality for Metrics Contract Services, Mr. Lewis is responsible for managing all quality-related functions to ensure the success of Metrics’ pharmaceutical operations. Mr. Lewis brings more than 30 years of pharmaceutical industry experience to his role. Before joining Metrics, he was senior director of quality for Teva Pharmaceuticals, where he managed quality assurance and quality control functions for a large solid dose manufacturing site. Having joined Mayne Pharma in 2014, Mr. Lewis holds a bachelor’s degree in chemistry from the University of North Carolina – Chapel Hill.Message Presenter
Jay Brown, Director of Environmental Health & Safety, Metrics Contract Services
As director of environmental health & safety for Metrics Contract Services, Jay oversees the designing, evaluating, and installing of novel containment solutions for HPAPIs during laboratory, development, clinical and commercial scale operations. Jay has over 33 years of global EHS experience with a Master of Science degree in Occupational Health and Safety. He is also a Certified Industrial Hygienist (CIH) and Certified Pharmaceutical Industry Professional (CPIP). Prior to Mayne Pharma, he was a Senior EHSS Specialist with Alkermes, a manufacturer of highly potent oral solid dose, long acting sterile injectables, and biological drug substances.Message Presenter
Who Should Attend?
- Pharmaceutical Development Groups
- Operations and Facility Personnel
- Quality Engineering and Quality Assurance Teams
- Environmental, Safety and Health Groups
What You Will Learn
In this webinar, participants will learn about:
- Proper assessment and categorization of experimental,development and commercial API’s in a manufacturing facility
- Addressing key cross contamination concerns by risk assessment and manufacturing and facility controls
- Assessing process flow and unit operations in the context of early phase development, small scale manufacture and scale-up/commercial manufacturing
Metrics Contract Services
Metrics Contract Services is a science-led contract development and manufacturing organization engineered around customers. We harness complexity and deliver confidence to companies developing novel oral solid dose products. With a 25-year track record, we support pharmaceutical companies from initial concept to global commercialization. Our skilled scientists and expert operators provide pharmaceutical development, analytical testing and commercial manufacturing to over 100 customers worldwide from our facility in Greenville, NC — all under a single FDA registration. We specialize in smaller batches, ideal for orphan drug development and niche patient populations. Our strong compliance record and best-in-class equipment make us the ideal partner for your novel oral solid dose product. We’re serious about science and sharply focused on novel drugs that make a difference. Metrics Contract Services is a division of Mayne Pharma Inc.