As pharma shows robust global growth of 2.48%, the strength of the industry is reflected in its continued innovation and breaking technologies that enhance manufacturing efficiencies and broaden the scope for potential therapeutic targets. Sarah Harding, PhD, reports from CPhI Worldwide.
CPhI Worldwide – the world’s largest pharma event – saw 45,000 visitors gather in Frankfurt, Germany, on 5–7 November 2019. Visitors came from over 160 countries for unbeatable insights into pharma’s latest trends and developments. Simultaneous with the event, CPhI launched this year’s Annual Report, including an evaluation of the pharma industry that suggested global growth of 2.48% in 2019. This healthy growth was interpreted as indicating increased confidence in the global marketplace, supported by broad innovation, breaking technologies and digitalization of the industry.
Demand for enhanced productivity, cost efficiency and sustainability are driving many of the disruptive technologies in pharma manufacturing. This is especially pertinent in light of the emerging model of personalized medicine, which is creating significant changes in the market, advised Peter Solkner, Managing Director of Vetter Pharma International. As many new drugs are developed for targeted population cohorts, the market sizes for those drugs are likely to shrink. As a result, explained Stuart Needleman, Chief Commercial Officer at Piramal Pharma Solutions, patient centricity is increasingly a focus of the pharma industry.
“There is still a lot of room for big volume products,” commented Dago Caceres, Global Marketing Leader at DuPont. “But the market for personalized medicine is growing – often for orphan indications, for which there are about 7,000 products in the pipeline worldwide. For these more focussed therapies, we need to make sure we maintain efficiencies while addressing smaller volumes.”
There can be no doubt that new models of healthcare, and the shift towards smaller volume therapies for targeted cohorts, are likely to have profound effects on the pharma supply chain. The future is likely to require more flexible manufacturing that must be as efficient as possible, as solutions for enhancing production help the industry to maintain its growth and ensure affordable, accessible healthcare for patients across the world.
A common solution is the implementation of ‘green chemistry’. Although the term was popularized in the 1990s due to an emerging awareness of chemical pollution and resource depletion, the basic principles of green chemistry – ensuring that chemical manufacturing is as efficient and economical as possible – have always been the basis of good chemical production. In other words, employing a green chemistry approach could add not just to a company’s sustainability credentials – it could also save money and increase a company’s manufacturing efficiency.
CatSci, a global process research and development CRO headquartered in the UK, develops perfect-for-purpose chemical processes that are economically and environmentally sustainable, using innovative thinking and applying extensive experience to explore new reactions and routes.
Jenny Wallis, Business Development Manager at CatSci, commented that “In the fast-paced and evolving pharmaceutical industry, drug discovery and development is getting more and more complex while demanding shorter timelines. Using our consultative approach, we work closely with our customers to efficiently navigate this challenging landscape and become their preferred partner for process research and development of small molecule therapeutics. Our award-winning chemistry services ensure that our customers can deliver affordable, best-in-class small molecule therapeutics.”
, winners of this year’s CPhI Excellence in Pharma Award for Formulation
, are addressing several of the pharma industry’s issues with one innovative approach. The company’s technology increases the active surface area of API particles, enabling significant improvements in dissolution rates and bioavailability. This, explained Edward Haeggström, Nanoform’s
Chief Executive Officer, addresses numerous challenges facing the pharma industry right now.
- ‘Failed’ drugs might be rescued if low bioavailability was the barrier to efficacy, potentially increasing the number of drugs entering the market and lowering overall development costs (which currently include to costs of 9/10 ‘failed’ drugs).
- Increased bioavailability means that lower doses – by up to ten-fold – might achieve equivalent efficacy to ‘normal’ formulations, potentially reducing the overall drug load and minimizing side effects.
- As APIs become more potent (due to higher bioavailability), the lower loads required could result in smaller drug manufacturing volumes, reduced environmental impact and a smaller footprint.
“Instead of using a cubic ton of CO2, manufacturers will need just a cubic litre,” said Haeggström. “Instead of needing a big plant for drug production, they will just need a room.”
Other novel solutions for enhancing efficiency include DuPont’s new METHOCEL cellulose ethers (hydroxypropyl methylcellulose; HPMC), which enable formulators to create reliable formulas for tablet coatings, granulation, controlled release, extrusion, moulding and for controlled viscosity in liquid formulations. These cellulose ethers make the manufacturing of tablets more efficient, eliminating the need for water and making them 60% faster to produce, explained Dago Caceres, Global Marketing Leader at DuPont.
Johnson Matthey (JM), in the meantime, has expanded its portfolio of homogeneous ester hydrogenation catalysts with the addition of another ‘Gusev’ catalyst. Compared with other agents used for these core reactions, said Kevin Gwilliam, Marketing Manager at JM, Gusev technology offers milder reaction conditions (temperature and pressure), which allow for a broader substrate scope and compatibility with a diverse range of functional groups.
“The Gusev catalysts produce less [often hazardous] waste than heterogenous alternatives,” said Gwilliam. ”They are more cost effective, and more sustainable.”
For the second time in three years, Cambrex won the CPhI Excellence in API Development Award, for its Crystallisation Screening and Process Development Service. The service has bridged the gap between the bench and manufacturing platform, providing controlled, robust and scalable crystallization processes.
Go with the flow
Another frequently cited solution to current efficiency and flexibility challenges in pharma manufacturing is the use of flow chemistry. Continuous processing, it is widely acclaimed, offers ‘process intensification’.
“It uses less water and less solvents, and produces less waste,” said Pierre Giuliano, Managing Director of La Mesta, a custom manufacturing company located in France. “Continuous pathways can provide better safety and productivity. It also gives us the ability to make compounds that simply could not be made with batch processing.”
“Flow chemistry certainly is a big focus,” agreed Stephen Drake, Manager of Marketing and Development at Kaneka, a Japanese international CDMO based in Osaka. “It allows us to deliver more projects in less time,” added Alan Walker, the company’s Vice President – Marketing and Development. In fact, Drake and Walker explained, Kaneka has won two flow chemistry awards in Japan in recent years, and has just inaugurated a GMP-certified metric ton scale continuous processing facility in Singapore.