Cambrex has recently announced several major investments across its global network of small molecule development and manufacturing sites to increase its capacity and capabilities to meet the growing demand from its customer base.
 

Like many Western contract manufacturing organizations, Cambrex is experiencing an increased demand, brought about by a healthy development pipeline of small molecule drugs and FDA approvals; alongside market trends that include the reshoring of projects from Asia.

The challenge for Cambrex, and other manufacturers looking to capitalize on this opportunity, is having the capacity to meet the demands of the market. Cambrex undertook a research exercise to evaluate the current state of the outsourcing market for small molecules, as well as looking at potential upcoming demand to ensure investments in capacity could be made in the most appropriate areas. As a result, since 2012 Cambrex has invested over $260 million around the globe in facility expansions, equipment, technology and EHS upgrades to ensure that these demands can be met whilst standards in quality, customer service, flexibility and reliability are not only maintained but enhanced.

At High Point, North Carolina, the company has made a series of investments since its acquisition through the purchase of PharmaCore in 2016. Most recently is the installation of multiple continuous flow reactor platforms to assist clients to rapidly and successfully develop synthetic processes to support clinical as well as commercial demand.
 

In 2017, Cambrex also introduced a dedicated commercial-scale continuous flow production unit at its Karlskoga, Sweden facility, which is capable of producing multiple metric tons of high purity intermediates per annum. The development capabilities in High Point will allow future projects to be transferred into Karlskoga as and when appropriate.
 

Additionally, at High Point, the GMP pilot plant has been expanded with two new 2,000 litre reactors, and a new 11,000 sq. ft. analytical laboratory has been constructed to support both analytical development and validation services, and the various manufacturing projects undertaken at the site. These include the synthesis of complex APIs and drug intermediates in batch sizes from milligrams to 100kg to support developmental and clinical phases. The site is also licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances.
 

At its Charles City, Iowa facility, work has begun on a $24 million, 4,500 sq. ft. new facility to manufacture highly potent APIs (HPAPIs) which is due to be completed early in 2019. When operational, the facility will be able to manufacture batches from 50 to 300kg. This investment is alongside increases to GMP pilot plant capacity, and the construction of an additional 2,000 sq .ft. of laboratory space for development projects and analytical work at the site. The total reactor capacity at the Charles City facility is now over 400,000 litres.
 

In Europe, Cambrex has also invested in the upgrade of its waste water processing facility at Karlskoga, to ensure it not only meets current environmental regulations, but also to allow for increased manufacturing capacity in the future as demand for manufacturing at the site increases. The $3.5 million upgrade is a three year project, with completion expected in 2019.
 

At Paullo, Milan, which is the hub of Cambrex’s manufacturing of generic APIs, expansion has been undertaken to increase the capability of the site to develop and manufacture HPAPIs, as well increasing the synthetic capabilities with the installation of a new 2,800 litre hydrogenator.
 

Small molecules continue to dominate in the pharmaceutical market, with the FDA approving 34 small molecule new molecular entities (NMEs) in 2017, which is the highest number in the last decade. There now exists the fastest growing small molecule clinical pipeline reported in the last 20 years, with more small molecules in phases I, II and III than ever before.
 

With these investments across its network, Cambrex is ensuring it is in a position to benefit from the opportunities as they occur, and is able to meet customer deadlines with available capacity, to advance projects as rapidly and efficiently as possible.