Learn more by reading: At-A-Glace Highly Potent API
Stay tuned for our next HPAPI post titled: 8 Characteristics of a State-of-the-Art HPAPI Facility
Given the risks highly potent active pharmaceutical ingredients (HPAPIs) present in cross-contamination and containment, it is important to consider manufacturing and handling approaches carefully. In fact, because of the demands of HPAPI manufacturing, many drug developers select a contract development and manufacturing organization (CDMO) partner to make the substance. The discussion below outlines some of the considerations for HPAPI manufacturing and, when appropriate, HPAPI CDMO selection.
HPAPI Manufacturing
With the significant infrastructure and capital investments required for effective HPAPI manufacturing, it is simply not feasible for many of the small and mid-size companies to make this extensive investment. In the suites alone, Alcami is investing approximately $7 million in 2017. Not to mention its investment in skilled personnel and procedural development. These levels of investment are not possible or prudent for many companies.
Some of the larger pharmaceutical companies have chosen to invest in high-potency manufacturing facilities, but even they often outsource manufacturing in the earlier stages of development before potentially transferring production to their own facilities in later stages or for commercial manufacturing. In this way, high-potency development and manufacturing for big pharma is not unlike other outsourcing models in the industry.
Selecting an HPAPI CDMO Partner
For companies that decide to outsource HPAPI manufacturing, it is critically important to understand what goes into highly potent manufacturing and to ask the right questions. The following is a list of questions to ask when selecting an HPAPI CDMO partner.
Warning Signs of an Ineffective HPAPI CDMO Partner
The Alcami Advantage– HPAPI Expertise
Alcami has built end-to-end service offerings that facilitate an integrated approach, from early-phase development through commercial manufacturing. This approach is embodied in our ProForm Select™ service offering, which integrates solid state chemistry, process chemistry, and formulation development to help ensure clinical milestones are achieved and processes are stable.
We have applied this approach to the development and manufacturing of HPAPIs. Our state-of-the-art manufacturing facilities meet global regulatory requirements and cGMP compliance standards. Our production, engineering, and development teams focus on developing and executing a robust process control strategy for right-first-time design and scale up of your API synthesis.
Learn more by reading: At-A-Glace Highly Potent API
Stay tuned for our next HPAPI post titled: 8 Characteristics of a State-of-the-Art HPAPI Facility
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In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and...
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The highly potent active pharmaceutical ingredient (HPAPI) market is growing rapidly with no signs of slowing down. But what is it, how is the market...
3 min read
In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and...