Three CDMOs in HPAPI advances

18. Mai 2021

Three CDMOs in HPAPI advances

Sterling Pharma Solutions, Novasep and Fareva have all made announcements in the high potency arena in the past week. Sterling has signed a manufacturing deal with oncology specialist OncoTex, while Novasep is expanding its main high potency API (HPAPI) site in France and Fareva has acquired a high potency drug product facility.

Sterling will produce clinical trial volumes of OncoTex’s novel oncology drug candidate, OxaliTex. This is a conjugate of oxaliplatin with a tumour-localising metallotexaphyrin for targeted drug delivery to cancerous tumours. It has been described as the first drug candidate to emerge from a new class of oncology drugs that are well-tolerated, overcome platinum resistance and are detectable by MRI.

Manufacture will take place at the cGMP facility Sterling acquired from Alcami late last year in Germantown, Wisconsin. This can handle HPAPIs in fully contained manufacturing suites. No financial details were disclosed about the agreement.

Meanwhile, Novasep said that it is investing more than €4 million and recruiting 30 additional employees at the site in Le Mans, where it develops HPAPIs and antibody-drug conjugates (ADCs), mainly for cancer treatment.

The company has been active in ADCs for 15 years and has offered integrated development and manufacturing services for both payloads and bioconjugation since 2017, when it opened its €12 million bioconjugation facility. This has recently had a successful inspection by ANSM, France’s pharmaceutical regulatory authority.

Novasep added that the Le Mans site “continues to exhibit strong growth as a result of longstanding collaborations with major pharmaceutical companies and new partnerships with biotechnology innovators”.

Finally, the Fareva Group has completed a five-year programme of investment in highly potent drug product manufacturing with the acquisition of a Novartis site at Unterach, Austria. This specialises in injectable, highly potent drug products, with packaging available in vials and pre-filled syringes.

In addition, Fareva Excella is currently investing €25 million in a new 2,850 m2 building that will make up to 500 million tablets or capsules/year, at up to OEB6 containment level, when it is complete in 2013. An additional suite for future demand is part of the programme.

Earlier, in 2015-6, Fareva had added further HPAPI capacity at Fareva La Vallée, France, with a pilot plant, a production building and additional R&D laboratories. In 2018-9 it expanded its analytical capabilities and added roller compaction for highly potent drug product at the Excella site in Feucht, Germany.

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