Managing complexity to bring drugs to clinic faster

The pharmaceutical contracting sector is thriving, fuelled by ever-growing drug industry demand for outsourced development and manufacturing solutions. The first CDMOs focused on the provision of basic manufacturing services, primarily finished product formulation, fill/finish, and packaging.

Broad expertise

In recent decades, specialist contractors have emerged to cater to the increasing range of work being outsourced. However, while such firms provide the drug industry with access to expertise, managing the efforts of multiple specialist contractors is a challenge that potentially outweighs the benefits of outsourcing in the first place. Taking outsourcing one step further, Recipharm has added capabilities by acquiring specialists and investing in in-house capabilities to provide our customers with a full range of services. Our approach simplifies and accelerates drug development.

Managing complexity

The development of each drug is different, although there are common stages. All drugs start as compounds that show therapeutic potential in the laboratory which, if they continue to show promise in preclinical studies, are selected for clinical development. The path from laboratory to first-in-human (FIH) studies involves many different steps, each requiring expertise.
For example, producing a drug product for an FIH study requires both formulation expertise and a detailed understanding of the trial protocol. In addition, while drug stability and bioavailability are less critical in FIH studies, knowledge of such characteristics gained during early formulation development can accelerate development of dosage forms used in later phase studies.
It is possible for multiple contractors to support each stage of a drug candidate’s journey from laboratory to clinic separately while ensuring materials and data are transferred. However, it is far more cost and time efficient if a contractor with expertise in all stages carries out such projects in a fully integrated manner. Likewise, a full service contractor that can help with each step significantly reduces a customer’s oversight burden.
With this in mind, Recipharm’s Pathway to Clinic® service provides pharmaceutical industry customers with a comprehensive range of fully integrated development, manufacturing, and clinical trial planning and execution services.

CDMO success

Integration is core to Recipharm’s offering. From our early development through clinical and commercial manufacturing, including serialisation, we focus on providing co-ordinated expertise that reduces complexity for our customers and gets high quality products to market faster and more efficiently.