Key challenges revolve around ensuring that workers and the environment are protected along with demonstrable and adequate controls to mitigate cross-contamination risks.
TORONTO (PRWEB)
June 08, 2021
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.
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?
Join expert speakers from Metrics Contract Services, Thomas B. “Brad” Gold, PhD, VP Pharmaceutical Development; Dwight Lewis, Vice President Quality; and Jay Brown, Director of Environmental Health & Safety, in a live webinar on Thursday, June 24, 2021 at 11am EDT (4pm BST/UK) to hear the presenters explore these issues and provide examples and information from years of real-world experience in handling high potency products.
For more information, or to register for this event, visit Potent Product Manufacture in a Multi-Product Facility.
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