NGT BioPharma Consultants employs a unique ‘collaborative ecosystem’ consulting approach to provide contemporary solutions for biopharmaceutical development and manufacturing’s complex technology process and platform challenges. Our technical experts and strategists work with an industry-leading network of equipment vendors, A&E firms, and innovative technology service providers to design, develop, and deploy transformative development & manufacturing technology processes, platforms, and facilities. NGT services include the following:
CASE STUDY – Acceleration Through Manufacturing Technology Innovation
A large pharmaceutical company sought to accelerate product launch timelines for several small molecule drugs in clinical development by transitioning from a batch to a powder-to-coated tablet continuous manufacturing platform. The company wished to accommodate smaller production volumes without compromising its ability to rapidly scale-up for anticipated variable supply demands.
Conceptual design of a modular, small footprint continuous tablet manufacturing platform inside of an autonomous shell that allowed for parallel workstreams at different locations was developed. Equipment platforms and factory shells were to be pre-fabricated and pre-qualified at different off-site locations concomitant to on-site facility preparation. A business case was prepared and presented to company governance bodies to align key stakeholders and secure project financing. Upon endorsement, we provided design and fabrication oversight in close collaboration with internal and external partners.
The new facility was fabricated according to plan and successfully deployed, commissioned, and validated in time for the commercial manufacture of a recently approved drug. The company planned to launch several small molecule drugs from this new facility.