The advantages of outsourcing highly potent API production

Posted by admin on September 22, 2016 in Uncategorized |

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


API synthesis

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.

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