Novel medicines. Vaccines to help prevent disease. The work we do in our labs has helped to save and improve countless lives. Thanks to our world-class researchers, state-of-the-art technologies and unrelenting focus on scientific excellence, MSD's global laboratories are at the forefront of discovering and developing new ways to treat and prevent disease.
Scientific discovery and development have always been the cornerstones of our company. Today, we conduct research in a broad range of therapeutic categories - including cardiovascular disease, diabetes, obesity, infectious diseases, vaccines, cancer, neurology and women's health. And, to help achieve our goal of saving and improving lives around the world, we are expanding our capabilities in new areas, such as biologics.
There has been significant investment in R&D at Hoddesdon over the last few years to establish a new European centre of excellence in preclinical development and clinical development.
The UK team based at Hoddesdon is a multi-disciplinary group, working closely with Merck Research Laboratories (MRL) scientists worldwide and with global medical, manufacturing and marketing teams. Its primary function is to develop potential drugs from the discovery stage into a marketable product. The major stages in the development phase are:
The Development Laboratories group comprises the following departments:
This group evaluates the physical and chemical properties of new chemical entities and formulations in development and provides analytical service to Process Chemistry and Formulation Sciences groups. The spectrum of activities includes raw material testing and approvals, method development, in-process and finished product testing for Process Chemistry, pharmaceutical evaluation of new drug candidates, preformulation, development and validation of methods for formulated products in Phase I/II, identification of degradates in bulk drugs and formulations, and stability testing.
This group designs and implements elegant, practical, efficient, environmentally benign and economically viable bulk chemical syntheses. The team is focussed on the definition and the large scale demonstration of synthetic processes to produce multi-kilogram quantities of high complexity, high priority Active Pharmaceutical Ingredients (API). The API produced, supports pre-clinical and clinical research.
This group is responsible for the development of optimal oral delivery systems for both clinical studies and for eventual marketing, in support of MRL's pipeline. The group is also responsible for the preparation of clinical supply materials.
GCS coordinates the delivery of clinical supplies for worldwide clinical studies. Materials are provided in a format that will enable studies to be undertaken in accordance with regulatory requirements. Each study can involve tens to many thousands of patients. The co-ordination of clinical study requirements and the planning of clinical supplies are the responsibility of this group. The group works closely with other similar Merck groups to provide a worldwide support service.
The quality assurance department ensures the systems and procedures used in Development Laboratories, Hoddesdon comply with both the internal and external requirements of current Good Manufacturing Practice and that the manufacturing equipment, services and facilities conform to all appropriate regulations. The Quality group is part of a global network of compliance units at our other Pharmaceutical Sciences and Clinical Supply sites worldwide and across the Merck Manufacturing Division (MMD).