Building strength in APIs
Contract API manufacturers and fine-chemical producers also are partnering to expand their collaboration. For example, in
2012, DSM and Almac formed an alliance in biocatalysis. The agreement grants both parties access to their enzyme platform
technologies, services, and expertise for the manufacturing of APIs. Almac brings to the table capabilities in enzyme identification,
scale-up, and implementation into early-phase projects, and DSM brings capabilities in commercial-scale bioprocesses to enable
production from preclinical to commercial-scale manufacturing. This collaboration will also enable Almac to offer its customers
a preferred partner for large-scale production.
In 2012, Carbogen Amcis and ADC Biotechnology formed an alliance to provide customers with development and manufacturing services
for antibody drug conjugates (ADCs). ADC Biotechnology is developing a "lock and release" solid-phase immobilization technology
for production of ADCs. The alliance will offer services for the development, scale-up, manufacturing, and formulation of
protein-based drug conjugates. ADC Biotechnology will provide access to proprietary solid-phase immobilization technologies
for conjugation and long-term storage of ADCs, and Carbogen Amcis will focus on focus on small- to large-scale GMP supply
and on the formulation of ADCs.
Onyx Scientific and Molecular Profiles partnered in 2012 to deliver end-to-end services from initial drug discovery to early-
and late-phase manufacturing. The complementary alliance involves Onyx Scientific's specialty in API production and initial
solid-state screening and Molecular Profiles' expertise in formulation and analytical development and early-phase clinical-trial-material
manufacturing. Onyx Scientific also has sites in India, at which it provides late-stage clinical-trial and commercial manufacturing
Alliances with academia also provide an opportunity for a CDMO or CMO to enhance its capabilities. For example, in January
2012, Almac completed its Knowledge Transfer Partnership (KTP) with Queens University, Belfast, to develop, improve, and embed
bioprocesses to facilitate the delivery of novel products for its biocatalysis business. The overall aim of the partnership
was to allow technology transfer of fermentation and molecular/microbiology expertise from Queens University to Almac. Almac
met the specific partnership objectives by sharing a program of work with academics at Queens and by attending training courses
organized through University College London, which allowed Almac to embed key learning back into the company. Since completion
of the KTP, Almac has successfully scaled fermentation and bio-oxidation reactions to thousands of liters.
Aesica formed a partnership with the Center for Pharmaceutical Engineering Science at the University of Bradford in the United
Kingdom to enable the team at the University of Bradford to use the GMP capabilities and assets held at Aesica while Aesica
will benefit from the center's research facilities. The partnership builds upon the relationship between the two parties.
The center offers several processing technologies, including HME, but relies on the GMP expertise of the formulation development
team at Aesica to manufacture GMP clinical-trial supplies.
The goal to offer integrated and more seamless delivery of services is also achieved through individual company strategy and
focus. For example, in 2012, AMRI launched SMARTSOURCING, an approach that further focuses its research and contract manufacturing
services to the various needs of the life-sciences and other industries. It is designed as a series of strategic sourcing
options for customers.
The rationale for the SMARTSOURCING arose in response to changing industry fundamentals, namely increased pressure on pharmaceutical
companies to deliver accelerated and increased drug-discovery success with reduced budgets and resources. Moreover, due to
downsizing in the United States and Europe, many large pharmaceutical companies have lost experienced scientists with drug-discovery
and development expertise, and as a result, may rely more on their contract service providers to fill knowledge gaps. This
provides further opportunity for CROs and CMOs to reconsider their current service strategies to find more appropriate ways
to meet the market's changing needs. SMARTSOURCING is an approach that seeks to address that by offering insourcing or outsourcing,
or a hybrid model of both, to deliver scientific expertise, according to an Apr. 30, 2012, AMRI press release.