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29 Sep 2017

Preparing for the high potency boom

Cambrex's new HP API facility in Charles City, Iowa - one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale - to offer clients complete flexibility across scale.

As a global CDMO specialising in branded and generic small molecule APIs, Cambrex is well placed to understand client requirements and market trends. Having recently announced a $24 million investment in new HP API manufacturing capacity at its Charles City, Iowa facility, the company provides CPHI-Online with further insight into their latest development.

What prompted the company to invest in HP APIs? Why not just stick to APIs?

There is strong evidence of a booming market for highly potent APIs (HPAPIs), which has been largely fuelled by the dramatic rise in New Chemical Entities (NCEs) being approved for oncology indications. Prior to 2010, there were approximately 2-4 approvals per year for oncology products, but that increased to 6-14 per year during 2011-2016. Oncology now accounts for approximately one third of FDA approvals and 30% of the small molecule clinical pipeline. It should be noted, however, that potent compounds are not restricted to that therapeutic class, and not all oncology products require high containment.

Why did Cambrex choose to build the new facility in Charles City?

Our Charles City, Iowa facility is Cambrex’s largest facility, located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale.

How exactly will the money be spent?

The new 4,500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1 µg/m³ and have a total reactor capacity of 2,200 gallons, which will be made up from a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300 kg.

The project will also reconfigure the existing small-scale manufacturing area providing a single high-containment building to support early-stage development and manufacturing, providing flexibility across a broad range of scale. Construction and installation of all new equipment is expected to be completed by Q1 2019.

In your experience, what are the main issues currently facing clients?

Our clients always have to struggle and deal with uncertainty of demand and in the case of HP API there is the added uncertainty of just how highly potent is it. As in its regular production facilities Cambrex is aiming to offer complete flexibility across scale to cope with fluctuating demand and containment for changes in handling requirements as the toxicology and physical properties of the product become more defined during the development cycle.

What advice would you give companies looking to source an HP API manufacturing partner?

Managing the potential exposure in manufacturing is not prescriptive, as it is facility- and equipment-specific, and requires experienced engineers and safety people to implement correctly, to protect both employees, the facility, and the surrounding environment. So in choosing an HP API partner you need not only the expertise in process development, quality and manufacturing you would normally expect but a well-integrated and experienced team of engineers including health and safety and skilled toxicologists.

How will your clients benefit from the new facility?

This expansion is in line with Cambrex’s commitment to ongoing investment in small molecule manufacturing, as well as responding to the rising number of APIs that require specialized handling due to potency and toxicity. Cambrex has built a strong reputation in the clinical scale supply of potent, and extremely potent molecules, and the flexibility that this facility will give allows us to effectively handle projects throughout their development and commercial lifecycle.

What are your plans for future investments?

Cambrex continues to invest across its global sites to meet market demands and customer requirements, and will continue its strategic growth both organically and, where appropriate, through acquisition.

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