HPAPIs down to OEB class 6
Minakem has a brand new 130 m² laboratory designed with state-of-the-art high containment technologies, for the specific support of antibody-drug conjugate (ADC) payload development and manufacturing, capable of handling compounds with occupational exposure levels (OEL) below 0.1 µg/m³.8-hour shift (OEB Class 6) providing segregated areas for powder handling and chemistry in solution. The laboratory is equipped with vessels up to 10L which enables MINAKEM to support its customers in manufacturing from mg to 100s of grams of ADC payloads and HPAPIs under GMP & non-GMP conditions to support clinical phases trials.
R&D and manufacturing activities are supported by preparative-HPLC under containment, from lab scale to a 50 mm column for development and scale-up and a 300 mm column for commercial scale. This providing Minakem with the capability to purify and isolate target compounds (including impurities) from highly complex chemical mixtures as natural extracts and fermentation products.
The site is fully integrated within the global MINAKEM and MINAFIN chemical manufacturing network which provides access to a broad range of technologies, chemical expertise and production capacity, giving our customers the opportunity for supply chain consolidation within the same partner.