Piramal Enterprises’ Pharma Solutions division, a world leader in contract development and manufacturing (CDMO), has set a target of becoming the market leader in ADCs contract commercialization during the next 5 years. This is based on its focused investments at its current site in Grangemouth, UK, and its recent acquisition of Coldstream – a specialized ADC fill/finish site, in Kentucky, USA.
The CDMO sees the market for commercial ADCs accelerating during the next few years and a steady increase in number of potential drug targets entering into the clinical phase. Piramal expects about eight drugs to move into its commercial production by 2020 which is a significant jump considering it only manufactures one commercial product today.
The CDMO suggests that despite the increase in development targets for ADCs, the global contract manufacturing sector still remains significantly under resourced with only a handful of players with experience and even less with the required regulatory accreditations.
Piramal is now in its fifth year of commercial production on the first ever commercial ADC in the market and is using this landmark to look ahead 5 years to cement its position as a leader in manufacturing of ADCs. During the last decade, Piramal has gradually expanded its internal teams and has nearly 150 ADCs specialists across its global sites.
There are currently two commercialized ADCs on the market and Vivek Sharma, CEO, Pharma Solutions, Piramal Enterprises, commented: “The situation with ADCs mirrors what happened when monoclonal antibodies (mAbs) first started to commercialize. At present, very few CMOs have the facilities or, just as crucially, the experience to develop them. At the moment there are only two CMOs, including ourselves, which are leading the charge in the commercial manufacturing of ADCs. Piramal is targeting winning at least one in every two commercial contracts coming to market during the next few years.”
Piramal views the acquisition of Coldstream’s fill finish site earlier this year as the final piece in the jigsaw puzzle and is now bullish about its prospects in the market.
Present bottlenecks begin with the small number of quality CMOs that can bring a product through clinical development. Second, the uneven spread of targets with most currently in very early stage research. Recognising this, Piramal has introduced a new ‘Proof of Concept’ service, designed to bring the most promising targets into clinical development more quickly.
Vivek Sharma adds: “For a pharma client, working with Piramal is an efficient and smart choice as we can take the product all the way from Proof of Concept to commercial manufacture. We have worked on more than 24 different products that include fill/finish and conjugation technologies, and have the track record and the experience of bringing a product to market. Our biotech and medium sized pharma clients understand the benefits of working with an experienced partner and prefer to leverage our expertise, instead of locking resources in developing the capabilities for ADC manufacturing in-house.”
Research on ADC targets shows that there will be at least a further 50 entering clinical work by 2020. During the next few years, it is likely there will be a wave of consolidations within the CDMO sector to acquire technology. Vivek Sharma comments: “We have been in the ADC market for more than 10 years, and it is an expertise we have built both organically and inorganically. We see the next 5 years as an exciting time for the ADC market and it will possibly have a sizeable contribution in the total biological CMO market.”