Challenges for Pharma Contract Manufacturer Organizations
Pharma companies are trying to outsource more and more manufacturing activities to contract manufactures so that they can focus on core activities of drug discovery and marketing. One estimate pegs the annual revenue from contract manufacturing and research activities to approximately 180 Billion USD for year 2010 with the annual growth rate of approximately 11%.There is a rapid rise in the pharma contract manufacturing organizations in India and China in recent years and this will further aid to the growth of the contract manufacturing industry. The blog explorers various challenges that CMOs are likely to face in medium to long term timeframe.
The Pharma Contract Manufacture Organizations (CMOs) needs to reinvent themselves for the challenges that lie ahead. From the traditional role of providing cost efficiencies, capacity, labor and machinery the CMOs have to get ready to the more complex process technology that would be required to manufacture new drugs. The challenges of stringent process control and increased automation will require further skills and new ways of working. Also, it is foreseen that specialty drug administration will have an element of information technology in it as controlled dosage would be required to be released at a targeted spot in patient's body. Though the technical know-how will be supplied by the pharma company but the CMOs have to invest both in technology and people to meet this challenge. To achieve efficiencies and to beat the competition, CMOs would have to invest in IT Application in areas of ERP, MES and Industrial Automation.
Adoption of GAMP (Good Automated Manufacturing Practice) will help CMOs to build in quality in every process step apart from having it in a batch of a pharma product. GAMP will ensure that quality is covered on all aspects of production for e.g. technical equipments, staff hygiene, raw materials etc. GAMP coupled with cGMP (current Good Manufacturing Practices) will yield better compliance of manufacturing installations, processes and related systems. Since the products are sold in global markets, it will be important for CMOs to have Quality system that meets the regulation of the various markets and of the pharma companies. Documentation compliance will be important as process is evolved and confirmed during trials.
CMOs will have to invest in project management skills as project scope would be exposed to scope changes owing to manufacturing complexity and various trial manufacturing runs and subsequent revisions during Lab to Plant Scale-up phases.
It will be interesting to know about other challenges as well. Please highlight any other
challenges that in your opinion will impact CMOs.