Webinar: June 24

2 mins 18/05/21
Author name: Dee Harper

Webinar: Potent Product Manufacture in a Multi-Product Facility

Thursday, June 24, 2021 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central) 60 min

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?

Speakers:

  • Thomas B. “Brad” Gold, PhD, VP Pharmaceutical Development, Metrics Contract Services
  • Dwight Lewis, Vice President Quality, Metrics Contract Services
  • Jay Brown, Director of Environmental Health & Safety, Metrics Contract Services

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.


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