The main advantage of outsourcing highly potent API (HPAPIs) manufacturers has abolished the need to
fund expensive containment base which can also be multifaceted to engineer install and maintain.
However, unless the particular the pharmacy company has a broad portfolio of HPAPIs in its pipeline for
instance infrastructure may not be fully utilized. Some of the highly potent API manufacturing benefits
Safe synthesis of HPAPIs requires considerable expertise in chemistry and a careful, rigorous approach to
Environmental Health and Safety (EHS). In API manufacturing, few CMO organizations offer the
services due to its high infrastructure costs the assets dedication to its high potency compounds.
Nevertheless, the GMP is required in the high amount to cross contamination within multi-product assets.
Currently, many biotech’s and emerging pharma companies and also CMOs rely broadly on the external
consultants to deliver pharmacological and toxicological guidance which eventually holds a grand final
categorization of an API. Having an in-house categorization expertise for APIs and upstream is very
critical, it ensures the expensive containment infrastructure is utilized where necessary and eventually
optimizes the economics of HPAPI manufacture in turn.
Cross contamination in API manufacturing
In API manufacturing, HPAPIs compliances with particular GMP aspects, this is also vital it helps to
prevent cross contamination between products which could bring severe harm to a patient. the GMP
necessitates the assessment of biological activities of the products produced to guarantee that proper
carry-over limits are set and followed accordingly while cleaning between the products. This has led the
development of cleaning protocols, analytical controls as well as maintenance of safe working practices
be the main elements of the HPAPI business. However, the entire APi manufacturing practices also
require particular expertise. The maximum allowed carryover limits are always severe since it requires the
development a very sensitive analytical methods to make sure all the limits are met.