• OSD Express, a defined solution designed to increase predictability and advance oral solid dose development more efficiently
• Steriles Express Solutions, a“ defined approach for early development and late-stage technology transfer” in sterile drugs that can provide Phase I or II clinical trial material in 20 weeks and a Phase III GMP batch in 26
Roger Viney, chief commercial officer at ICE Pharma, describes bile acids as“ nature’ s answer to solubility”. The company sources bile acids from meat processors in over 80 countries and supplies about 70 different finished products as excipients and intermediates via a fully integrated chain.
“ We have independent lines so if we lost a factory, it would not be a problem,” Viney said.“ We were also completely independent of China before having a‘ China-free’ supply chain was ever in demand, while some of our competitors are struggling to source intermediates from outside China.”
Business is growing at mid-singledigit rates, driven essentially by the ageing population and rising demand for generics, he added. Over the last three years, ICE has also developed a range of its own products and invested in new capacity as a CDMO for finished dosage forms.
Advantage India?
One person who would not agree with Hovione’ s Gil about what customers are seeking is Siddarth Mittal, CEO and managing director at India’ s Syngene International. Syngene, he said, is one of very few CDMOs integrated all the way from drug discovery to manufacturing in small and large molecules, ADCs and more. He sees customers, particularly biotechs, increasingly seeking to work with fewer‘ one-stop shops’, often just one.
Syngene is also capitalising on the demand for US-based supply. It is seeking to get the facility in Maryland, which it acquired from Emergent
Biosolutions and is converting it from vaccines to multi-purpose manufacturing, qualified and open by the end of the year.
“ Of course no one can be best at everything, but we have 30 years of experience in biology and chemistry and many customers see us as the best in biology,” said chief commercial officer Abhjit Zutshi.“ We are now looking at biological manufacturing at scale.”
ADCs, peptides, oligonucleotides and fill-finish have been the main driver of growth and will be the focus of further investment. Syngene can make all four of the components of ADCs and will decide shortly on building a conjugation facility in the US. A commercial peptides facility will be commissioned next year to complement pilot-scale manufacture.
An integrated offer from key starting materials( KSMs) to APIs is also integral to the philosophy of Shilpa CDMO, a new company that was launched at CPHI Milan. According to CEO Keshav Bhutada the company is enjoying a CAGR of 20 %, driven by being a one-stop shop and the demand for service levels and integration that come with it.
Shilpa is known for supplying HPAPIs for oncology at Occupational Exposure Bands( OEBs) 1-6 and has made cytotoxic drugs, including peptides, down from batch sizes of 5g to hundreds of kgs. This also ties in with the ADC capabilities of its sister company, Shilpa Biologicals. A unique capacity is a DM1 payload based on ansamitocin.
Analytical laboratory at Jubilant Ingrevia
Bhutada revealed that Shilpa will invest about $ 50 million over the next five years in peptides and payload linkers for ADCs. Manufacturing is currently in India but Shilpa has partnerships in the US and Europe for those seeking local supply of APIs.“ Most of our clients want China-free raw materials and registered starting materials( RSMs) and we have a network of 500 Indian suppliers we can outsource to at any point,” he said.
Powerful stuff
Similarly, Aragen Life Sciences, which claims to be one of India’ s top three CRDMOs, has just begun operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad, with 500-600 kg / year of API capacity. This also adds capabilities for cytotoxic payloads used in oncology, the company said. Another Indian firm investing in HPAPIs is Acutaas Chemicals, the former Ami Organics, which has just inaugurated a pilot plant at its Unit 1 facility at Surat. This includes a dedicated area for OEB 4 containment, enabling the company to undertake the development and scale-up of intermediates for HPAPIs.
Jubilant Ingrevia, a diversified Indian chemical company, has also been adding new capabilities in the past year, building on a base in pyridine and acetyl intermediates. Based on this, said CEO Deepak Jain, it is scaling up its pharma CDMO with the brand name Ingrevia CDMO. This will offer GMP and non-GMP KSMs
18 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981