Faster progress towards an animal-free regulatory system

Over a decade ago, the European Commission committed to ultimately replace animal testing. Yet still today, the acceptance of existing non-animal testing remains low in Europe. With the imminent revision of REACH, the question remains: how can we develop an assessment framework that reflects scientific progress and incorporates New Approach Methodologies or ‘NAMs’ into the REACH process to the greatest extent possible?

To support transition to an animal-free regulatory system, ECHA recently organised a workshop which brought together key stakeholders to discuss critical needs to enable faster progress. Improving the safety assessment of chemicals is crucial for promoting innovation in safe and sustainable products. However, there are challenges to overcome: like it is important to recognise that NAMs are not a one-to-one replacement for current testing methods, and there is also a need to build confidence in the effectiveness of NAMs-based safety assessments compared to animal testing. The ECHA workshop aimed to build a common understanding of what NAMs can achieve in the short and long term.

“We don’t believe that the protection

Olon enters in ADC market

Olon Group, a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and general markets, announces the start of construction of a new facility at its Rodano site (Milan, Italy) which will be entirely dedicated to managing and producing Ultra-Potent compounds, used for example as payloads and payload-linkers for antibody-drug conjugates (ADCs), one of the most promising emerging cancer therapies, which combines the ef-fective killing power of small molecule cytotoxins and the highly specific targeting ability of monoclonal antibodies (mAbs).

“Actually, about 80% of the ADCs either approved or under development contains this type of payload, such as Dolastatins or Maytansnoids” said Giorgio Bertolini, SVP R&D Olon Group, “and there are also other highly strategic classes of cytotoxic payloads, such as Anthracyclines, Camptothecin and Calicheamicin.” The Italian group, with years of expertise in

HPAPIs, has invested €22 million in a new facility dedicated to these ultra-potent compounds. The ultra-high-containment production line will produce high-potency and toxic products and will therefore reach containment level OEB6 (target OEL 10 ng/m3).

The new project foresees the complete construction of a new building, within which a second “shell” will be built, containing the production facility and the quality control and research and development areas, as well as all auxiliary facilities. This complete, closed-loop system will include all steps of the process: synthesis, isolation, drying and analysis; an ultra-high-containment plant.

The first phase of the construction, to build the payload research and development area, has already begun and completion is foreseen by H1, 2024. Once completed, the company will move on to the sec-ond stage of finalizing the production line by creating the QC and GMP Production areas, with the in-stallation of health and the environment versus no animal testing is an either / or situation. We think we can do both”, said Sharon McGuinness, Executive Director, ECHA Representing Cefic, Chantal Smulders, Global Head of Product Safety Science and Regulatory Advocacy at Shell shared industry views on how to achieve a modernised and accelerated chemical safety assessment. She presented a comprehensive fourpoint action plan to facilitate a responsible transition, increase acceptance, and foster confidence in the application of NAMs. industrial production equipment. For the Italian-based contract development and manufacturing organization (CDMO) which has worked with highly-potent APIs (HPAPIs) – including anti-cancer drugs and cytotoxic – for over half a century, the decline of the blockbuster, high-volume model in oncology and the rise of niche therapies based on precision medicine are creating new opportunities for continued growth.

“The future of regulatory testing is animal free. One day soon we can get there if we put in place the right regulatory framework and support ”, commented Tilly Metz, Member of the European Parliament.

Olon is one of few suppliers in the global API market able to integrate every level of containment from the initial API development to commercial manufacturing and from a few grams to hundreds of kilo-grams.