Building Toolboxes through Cross-Functional Partnerships - Pharmaceutical Technology

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Building Toolboxes through Cross-Functional Partnerships
In the arena of pharmaceutical outsourcing, when speaking of partnerships, the discussion typically focuses on the relationship between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract-service provider.


Pharmaceutical Technology


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 services.

Academic–CDMO/CMO relationships

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.

Other models

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.


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