Investment in continuous manufacturing vital for CDMOs

Contract development and manufacturing organisations (CDMOs) will need to invest in continuous manufacturing sooner rather than later if they are to stay competitive, a report from CPhI Worldwide has concluded.

Emil W. Ciurczak, of Doramaxx Consulting, and Fiona Barry, editor at PharmSource, a GlobalData product, analysed the effects of continuous manufacturing and contract manufacturing in response to recent quota changes for controlled substances by the Drug Enforcement Administration.

Ciurczak predicts that over the next five years, exponential growth of continuous manufacturing will be driven by competitive and financial pressures, alongside better equipment and a larger pool of trained scientists. Within the next 10 years, Ciurczak predicts that all generic manufacturers and CMOs will need to convert to continuous manufacturing.

“The companies who have begun using CM have enjoyed (overall) success, making products faster and with virtually no rejects. The movement from development to full-scale production, skipping the scale-up step (as much as six months) brings the products to market faster. The question is no longer, “Will Continuous Manufacturing work?”, but “When will everyone be doing it?”, Ciurczak said.

Whilst pharmaceutical companies might not feel the need to convert to continuous manufacturing yet, industry-wide changes are putting production costs under new scrutiny. Ciurczak explains that competition between countries, pricing restrictions and the cost of R&D means that raising prices to consumers is no longer a viable option. Manufacturers that fail to invest in continuous manufacturing will be left behind within the next 10 years, the report predicts.

Recent changes in US regulations have created opportunities and threats to CMOs, Fiona Barry examined in the report. Barry predicts that many CMOs will be hit hard by the proposed production cut of opioid compounds by the DEA. She also predicts that the development of non-opioid painkillers could become a profitable opportunity for non-CMOs and drug companies in the future.

“Out of the 30 CMOs involved in commercial drug manufacture using controlled substances, 18 (60%) produce opioids. While contractors involved in controlled substance production constitute a minority of US CMO facilities, it is clear that they will be hit particularly hard by the reduced volumes of opioid manufacturing. The ever-growing number of opioid lawsuits—such as the US state lawsuits against Purdue Pharma—is likely to deter pharma companies from producing and outsourcing these products in the future.

“However, opportunities for CMOs and drug companies relating to non-opioid painkiller manufacture are likely to become more lucrative in the future, as alternatives to addictive opioids are sought,” Barry said.

New approvals of cannabis-derived drugs may be in the pipeline as regulatory attitudes towards the products change. Barry noted that the first FDA approval of a plant-derived cannabinoid drug, Epidiolex, highlighted the growing trend in the market.