Speciality Chemicals Magazine SEP / OCT 2021 | Page 20

High potency was a key feature among the announcements companies made virtually in July . We report from DCAT Week 2021

More power to you

High potency was a key feature among the announcements companies made virtually in July . We report from DCAT Week 2021

Member company announcements remained a key part of the event at DCAT Week , which took place virtually this year . As ever , these were vetted for being genuinely new and most included substantial investments in capacities and capabilities . Some had not previously been in the public domain The biggest investments are still being made in API capacity by Chinese firms like PharmaBlock and WuXi STA , and in biologics by Boehringer Ingelheim , Catalent and Samsung Biologics , among others . However , investments into HPAPI manufacturing were a significant part of the news . Indeed , HPAPIs are a part , albeit an unspecified one , of WuXi STA ’ s huge new campus at Taixing . As often in the past , Swiss CDMOs led the way , often citing the same drivers behind their decisions . For instance , Christian Dowdeswell , head of commercial development for small molecules , said that Lonza ’ s investments this year in small molecules , biologics and cell and gene therapy alike , are all being driven by similar trends . Clinical development and final approvals are increasingly coming from and dominated by small and emerging companies . The innovation is coming from small companies , who are driven by speed to market and typically lack much of the internal expertise needed to get there . They thus need the help of the right CDMOs , Dowdeswell said . In small molecules in particular , the molecules themselves are growing in complexity – the average number of synthetic steps has roughly doubled in the past ten years – and bioavailability remains a thorny issue . With all this and oncology increasingly dominating the pipeline , high containment in specialised assets operated by experienced teams is needed more and more .

Lonza itself is now building a dedicated plant to supply the API voclosporin for Aurinia at its main site in Visp , Switzerland . It has already included a suite for the production of highly potent linker materials , expanding its capabilities in both the dedicated suite and a multipurpose suite . Both can now handle compounds with OELs down to 1 ng / m 3 . “ However , demand is so strong that we recently announced a further investment of $ 200 million to expand production of payload linkers for ADCs ,” Dowdeswell said . “ The high potency suite actually occupies 40 % of a very large building , so the investment includes the ability to expand rapidly into further areas and we are currently exploring the utilisation of that expansion space for API manufacture , commercial spraydrying and associated drug product .” Another Swiss-based CDMO , Carbogen-Amcis , had recently
20