Firelli Alonso-Caplen, Ph.D.
In this era of mergers and acquisitions, collaborative manufacturing partnerships, and increasing numbers of outsourcing deals, the biopharmaceutical industry faces the challenge of adopting the best externalization strategies that are financially sound, and that ensure adequate oversight without hindering a Contract Manufacturing Organization’s (CMO’s) operational efficiency. In pre-commercial outsourcing, quicker to clinic is critical, without sacrificing quality, and preferably, at lower costs!
Natalie Barger, Leu-Fen Lin, Ph.D., Sunil Potdar, MS, Paul Skultety, Balaji V. Kadri, M. Pharm., M.Sc., MBA, Harsh Chauhan, Ph.D., Kevin Koziatek, MBA,CPIM
The pharmaceutical development process is a complex and dynamic one, requiring detailed knowledge of API characterization, formulation, process, and analytical development, sound experimental design, and regulatory requirements.
Thomas M. Eckrich, Ph.D.
An active pharmaceutical ingredient (API) sourcing strategy is built upon a well-defined manufacturing process. The keys to the strategy involve using long-term suppliers early in the development process so that the control strategy for their manufactured material can be developed over time and included in all supporting registration studies. From a business perspective, a supplier’s performance during product development can also be used as a predictor of long-term supplier success. Therefore it is essential to engage in source development at all stages of the API’s development.
Mark McAllister, Ph.D.
Formulation science and technology have delivered a number of diverse approaches such as particle size reduction, solubilizing excipients or stabilized amorphous systems to overcome the twin obstacles of low solubility and dissolution rate limitations which would otherwise impede drug development. In preclinical development, API bulk availability is often a constraint for formulation activities and as a result, the use of bioenhanced drug delivery systems will only be assessed after simpler approaches such a coarse particle size reduction (e.g by mortar and pestle grinding), suspension preparation or salt formation have been eliminated as viable formulation options.
Mark Birse, Neil Raw
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the UK. The MHRA is responsible for the regulation of medicines and medical devices, equipment used in healthcare, and the investigation of harmful incidents. The MHRA is also the competent authority for blood and blood components. The principal aims of the Agency are to protect, promote and improve the public’s health.
Ken Phelps
First, smaller companies choose to outsource drug development services. Second, they make decisions quickly, which facilitates smaller service providers like Camargo.