Unlock the Benefits of Outsourcing Your Formulation Development and Manufacturing

Why Outsource Formulation Development and Manufacturing?

Partnering with a Contract Development and Manufacturing Organisation can provide services from early-stage clinical development through to clinical and commercial manufacturing and packaging, including full technical and analytical support, launch capabilities and final distribution. Engaging in this service model from the early stages of drug development can provide many benefits.

Compressed Timelines

Outsourcing early development can accelerate candidate selection to clinical trial entry, and ultimately get to proof-of-concept as quickly and efficiently as possible. Some large pharmaceutical companies may pursue ‘reserved capacity models’ to guarantee access to formulation, analytical, and manufacturing capacity and resource ensuring they can move multiple assets in their portfolios forward quickly when the need arises.

Integrated Supply Chain

Availing of single source integration of development and commercial resources including Technical, Analytical, Quality and Project Management ensures scientific continuity and simplified effort, saving time and expense whilst reducing vendor management and mitigating risk to the overall project. This alleviates unnecessary concerns for the sponsor company, providing a cohesive and smooth transition from development to production.

Experience

Selecting an established, reliable CDMO with a high level of experience is key to a successful partnership. They should be able to provide a wealth of previous knowledge in early development and manufacture and be able to deliver quality data in pre-formulation and formulation of oral dosage forms. Collaboration throughout the product’s development and commercial lifecycle can provide the client with access to teams with specialist knowledge and experience as and when the product demands it, for example, in fields such as development and manufacture of paediatric formulations.

Technology

Engaging with a an experienced CDMO provides a company with the benefit of knowledge and proven track record, but also access to a wide range of capabilities, technologies, and development facilities for both non-GMP and GMP product batches. This ensures not only complementary equipment trains, but also integrated technical teams to facilitate a product’s increasing scale demands through the development lifecycle.

Regulatory Guidelines

Partnering with the right CDMO ensures that the strict regulatory guidelines surrounding pharmaceutical development and manufacturing will be adhered to. This alleviates the pressure from companies to stay up to date with recent guidelines and provides surety that their product will meet all its regulatory milestones on time, every time.

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