Pharma CDMOs in multiple deals
4th May 2021
Lonza its to expand its two-year collaboration with Moderna to manufacture the drug substance for Moderna’ COVID-19 vaccine. It will install three additional manufacturing lines at Visp, Switzerland, alongside three existing ones.
The new lines expected to have the same capacity as the existing lines, thus doubling capacity, and to be operational in early 2022. Lonza and Moderna had agreed a ten-year strategic collaboration in May 2020 and Lonza had since added another line at Portsmouth, New Hampshire.
Shortly before this, Lonza had announced that it was to build a new, CHF 200 million small molecule complex at Visp, focusing on high potency treatments for cancer. This will cover about 2,000 m2, with six levels of manufacturing space. On completion, it will employ about 200 people and the firm is already recruiting.
The first build-out will be a dedicated line for antibody-drug conjugate (ADC) payload molecules for an unnamed, global biopharmaceutical firm, which has made a major capital contribution to it. This should start operations in Q3 2023. Further expansion possibilities are envisaged in drug substance and product, and particle engineering technologies.
Carbogen Amcis is to build an extension at its main Bubendorf site, also in Switzerland, to make a complex, highly potent intermediate for a commercial ADC API for long standing Japan-based customer, who is contributing to the cost. The planning phase is under way and operations should commence in autumn 2022.
The expansion will incorporate a new production line, comprising two 850 L reactors and one agitated filter dryer. The facility is designed for manufacturing up to Category 4 (OEL <1 µg/m3). Four other Carbogen Amcis sites – two in Switzerland, one in the UK and one in China – are also involved in manufacturing this intermediate.
AMRI has invested in terms of scale and compound handling capabilities and new personnel to address orphan and rare disease products. Defined as those affecting fewer than 200,000 people in the US and fewer than one in 2,000 people in the EU, rare and orphan diseases accounted for the 31 of the 53 novel drug approvals by the FDA in 2020. They have been projected to grow at 12%/year in prescription sales to 2026.
At its headquarters site in Albany, New York, AMRI has added additional suites for 10-15 kg batch sizes. At Grafton, Wisconsin, it has expanded its hydrogenation, filtering and drying and analytical capabilities, the latter including LC-MS and GC-MS instruments, as well as new experts. The company has also expanded at its site at Glasgow, UK.
In India, Piramal Pharma Solutions (PPS) has acquired Hemmo Pharmaceuticals for about $106 million and earn-outs linked to milestones. Hemmo is one of India’s largest manufacturers of synthetic peptides and one of the few pure-play companies in this field in the world, with R&D capabilities and a GMP-compliant manufacturing facility. This will take PPS into peptide APIs for the first time.
Also in peptides, CordenPharma has signed a Master Service Agreement to produce Revolo Biotherapeutics Revolo Bio’s first-in-class peptide and immune system resetting drug product, ‘1104, to cGMP for Phase II clinical trials at its facility in Colorado. It also has capacity for commercial production of the API, which is targeted at aeosinophilic aesophagitis and allergic disease.
Finally, following on from a strategic investment in December, Sterling Pharma Solutions has wholly acquired ADC Biotechnology, a UK specialist in bioconjugation for ADCs. A multi-million pound investment is planned in expanding the technical and analytical services team, particularly in cGMP and establishing cGMP bioconjugation and ADC manufacturing at the Deeside site in 2022.
For more information visit www.specchemonline.com/