It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past.
“We’ve had improved measurement systems, including light-induced fluorescent spectroscopy (LIFS), near infrared (NIR) and Raman, for years, and have used them to guarantee mixing,” noted Ciurczak, “but now there are automated systems that operate continuously that will allow us to speed up pre-pilot-scale work in design of experiments (DOE), technology transfer and the determination of the design space.” He pointed out that these systems eliminate some of the problems observed with conventional methods when moving from laboratory scale to small manufacturing scale. DOE can now be done in a matter of days with the newer systems instead of weeks or months. Such improved tools lower the costs of manufacturing and enable branded players to get more value out of their products while still under patent. According to Ciurczak, there will be less complains in the future about DOE and quality by design (QbD) costing too much or tying up equipment.
Ciurczak also believes that in the next 10 to 15 years, it will be hard to differentiate between a generics and branded pharmaceutical facility especially with FDA’s plans to use question-based review (QBR) for both generics and name brand applications. “Currently, QbR is putting pressure on generics manufacturers to know more about their products,” Ciurczak said. He also anticipates that most generic companies will merge and there will be a smaller number of larger generics and “for regulators, this will mean fewer facilities to inspect,” said Ciurczak. He added that he expects to see more collaboration between FDA and EMA and a move to establish a “United Nations of Regulatory Agencies.”
Another interesting point, highlighted by Girish Malhotra, president of EPCOT International, is that Big Pharma won’t be able to survive on expensive drugs alone and companies will need to invest in developing low-cost drugs that reach a larger customer base. This change in business model is driven by a diminishing pharmaceutical pipeline accompanied by low success rates in launching new products. While branded players may turn to biotech drugs or combinations as an alternative, such effort, however, takes more than five years to commercialize, said Malhotra. Moreover, generic drug-makers will continue to be a threat to Big Pharma’s revenue stream.
Malhotra also noted that both branded and generic players are increasingly targeting the African market. “Prices will have to be lowered to serve the continent,” he said. “If the patients in Africa are not able to afford the drugs at prices offered, compulsory licensing might be adopted by the respective governments and that might not be what the brand pharma are looking for.”
When asked about the impact of regulations on APIs and manufacturing, Malhotra said that such stringent requirements could result in drug shortages. “Branded companies will not have much impact of the regulatory wrath as they have limited sites and mechanism in place to comply with regulations,” he said, but developed countries, on the other hand, do not have sufficient manpower for the oversight and are at risk of failing to meet such regulatory requirements.
Regarding pharma’s adoption of process analytical technology (PAT) and QbD, Malhotra stated that minimizing process inefficiencies with PAT and QbD could potentially save companies as much as 20% – 25% of their global revenue. “We have multiple opportunities to lower the costs if we become process centric,” he said. “Costs to incorporate PAT and QbD are significantly lower if done from the process development stage rather than after the fact.”
Companies tend to rationalize based on economics rather than prevalent practices. In addition, regulations often grab the spotlight with companies making every effort to deliver the quality products to meet regulatory standards instead of taking advantage of the best technology that will deliver quality. “This approach and methodology does not work in any other industry,” Malhotra noted. “In pharma, this works because the industry has been able to pass the inefficiency costs to its customers. Customers want to extend their life at all costs. Survival and life extension over the lowest price have driven pricing.” Governments are now stepping in to control drug prices, and the industry has been fighting such cost-containment policies ever since by arguing that they need to recoup R&D costs for new drugs. However, the problem, according to Malhotra, is that pharma is hardly putting in any effort to minimize or eliminate inefficient practices in the current business model.