White Paper | March 31, 2014

Choosing The Right CMO For HPAPI Manufacturing

Source: AMRI
cmo for hpapi production

Over the past few years a steady stream of contract manufacturing organizations (CMO) have added  high potency active pharmaceutical ingredient (HPAPI) production capacity. The expansions give biopharma executives charged with selecting HPAPI production partners an unprecedented number of options, but all this choice creates a problem — which CMO should you pick when each is touting similar technical capabilities?

When looking at CMOs from a purely engineering perspective this is a very tricky question. As an  industry we now know what it takes to manufacture HPAPIs. The engineering controls, toxicity and potency evaluations, and containment strategies that make HPAPI production possible are well understood and in place at multiple CMOs.

Each manufacturer takes a slightly different approach to designing their plants and policies, but nonetheless their operations still address the same essential elements of HPAPI production. On one level this is a positive for anyone tasked with picking a CMO for HPAPI production. Yet even though multiple manufacturers have the same basic technical capabilities, the services they provide are
separated by far more than just timing, location and price. Sellers and sourcers of HPAPI services understandably focus their talks on production operations, but successful CMOs know manufacturing
these demanding ingredients is a test of more than just engineering expertise. Producing HPAPIs is a mission for the whole company.

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