API outsourcing – A perspective from an integrated drug development solutions provider
The pharmaceutical industry is facing challenging times. Patent cliffs and weak internal candidate pipelines now seem to characterize many of the large companies and the turmoil of global recession continues to place additional stresses on the biotechnology sector. The traditional drug development challenges of speed to market, programme cost and drug candidate attrition remain and the necessity to add value for investors and shareholders alike creates further pressures. The contract research and manufacturing sector is changing to meet the new demands and opportunities that the marketplace presents. Quality, customer care and delivery are now baseline expectations and demonstration of additional added value at the right price is taking centre stage.
TECHNICAL KNOWLEDGE AND EXPERIENCE
First time scale up of an API has always been a complex challenge, more so now than ever. The complexity of new drug candidates is increasing as is the typical number of synthetic steps. Powerful technologies such as microwave chemistry, mass directed preparative HPLC and resin bound reagents have streamlined the working processes with medicinal chemistry laboratories, leading to ever more efficient strategies for the synthesis of families of drug candidates. However, when this chemistry reaches early development phase, these technologies are no longer of relevance. The more capable CROs have development chemists who are deeply experienced in first time scale up and technologies that can present new route options. An excellent example of such a technology is biocatalysis. Biocatalysis is a science whose time truly has come. When correctly applied, it delivers excellent stereocontrol, yield and scalability with superb green credentialsi. Unlike chemocatalysis, biocatalytic processes do not generate heavy metal waste, often require no protection, deprotection steps and can often be run in environmentally friendly solvents ...