Speciality Chemicals Magazine JUL / AUG 2023 | Page 11


Olon to build ADC payloads facility

Italian CDMO Olon has announced the start of construction on a € 22 million facility for the production of ultra-potent compounds . These are aimed for use mainly as payloads and linkers for antibody-drug conjugates ( ADCs ) at its site at Rodano , near Milan . The facility will reach containment OEB Level 6 , with a target occupational exposure level ( OEL ) of 10 ng / m 3 .
“ About 80 % of the ADCs either approved or under development contain this type of payload , such as dolastatins or maytansnoids ,” commented Giorgio Bertolini , VR of R & D . “ There are also other highly strategic classes of cytotoxic payloads , such as anthracyclines , camptothecin and calicheamicin .”
The first phase , to build the payload R & D area , should be complete by 1H 2024 . The company will move onto the second stage of finalising the production line by creating the QC and GMP production areas , with the installation of industrial production equipment . Olon has over 50 years of experience in HPAPIs , including anti-cancer drugs and cytotoxics .
The company has also just announced a further milestone in its plan to expand and increase production capacity , particularly at the Mulazzano site near Lodi . It will install an
advanced mill for grinding finished APIs , which will operate in a fully closed-loop containment , up to OEB Level 4 . The overall expansion strategy is supported by a recently announced annual investment plan that will reach € 100 million in 2023 .
Olon subsequently revealed that it would install a new fermenter at its biotechnological production site in Mahad , India , which produces biotech APIs by microbial fermentation . Accompanied by further capacity in the downstream lines , this will increase Mahad ’ s capacity by 20 %.

Progress being made in non-animal testing : ECHA

ECHA has published its fifth triennial report on the use of alternatives to testing on animals for REACH . Based on data from 12,439 registered substances up until 31 July 2022 , it concluded that progress is being made and alternatives are widely used when assessing the safety of chemical substances .
As with previous report , the most common adaptation is read-across , where information from similar substances is used . This is followed by justifications for omitting data ( data waiving ), combining information from different sources ( weight of evidence ) and predicting properties from structurally
There has been a notable rise in animal tests in the past year similar substances using computer models ( QSAR ). Recent years have also seen a notable increase in the use of in vitro test methods , notably for skin corrosion and irritation , serious eye damage and irritation , and skin sensitisation . Of all new studies between 2019 and 2022 for skin and eye irritation , 90 % were performed in vitro compared to 50 % over the whole period between 1990 and 2022 .
Together with the European Federation of Pharmaceutical Industries and Associations , ECHA has also published an updated set of archived data from unpublished chemical tests available on the IUCLID website . This has added information about the hazard properties of 75 substances from 370 tests , bringing the respective totals to 94 from 517 .
This data can help , among other things , to develop predictive computational testing models , read-across and other non-animal test methods . Seven major pharmaceutical companies , including Bayer , GSK , Merck & Co . and Novartis , are participating in the initiative .