Rahway, New Jersey, United States
Merck & Co. B880 Formulation Center
Lendlease is providing EPCM Design/Build services to Merck Research Laboratories (MRL) for their new Formulation and Laboratory Experimentation (FLEx) Facility, a multi-product facility.
Project outcome
The formulation research center is designed to support product development and clinical supply execution for both human health (sterile and oral solid dosage) and animal health (non-sterile) products. This, paired with new laboratories, will provide a state-of-the-art research and development center that will transform drug product and analytical development to the client, allowing them to continue to develop their complex and evolving pipeline.
The key capabilities and aspects of the facility are as follows:
- Drug product development capability to utilize next generation Process Development including small scale, single use, traditional and continuous manufacturing platforms
- Sterile formulation and filling for BSL 2 and small molecule products including all OEB 1 through 5 compounds
- Sterile Lyospheres formulation, bead freezing and dispensing including LVVs, BSL 2 and OEB1- 3 compounds
- HH Oral Solid Dosage unit operations including blending, milling, granulation (wet and dry), tableting, coating, encapsulation and solvent spray drying. All areas will be able to process OEB 1-3 compounds with some areas handling compounds up to OEB 5
- AH facility capable of producing topicals, liquids, soft chews and tableting capability to handle OEB 1-4 compounds. The facility will be OEB 5 capable
- Accommodate variable batch sizes up to 100 KG for OSD and 50 L for sterile to support development and clinical scale production
- Solvent processing in designated areas for each modality
- Flexible, expandable and portable/transportable areas to support the future introduction of new process technologies and the emerging complexities associated with global clinical supply chains