We are at the forefront of highly potent active pharmaceutical ingredient (HPAPI) development and manufacturing, combining cutting-edge technology with an expertly integrated research and development (R&D) team.
Our specialized capabilities in handling cytotoxic and controlled substances, along with our advanced purification technologies, ensure the highest level of safety, efficiency, and innovation.
High-containment conditions
Handling HPAPIs requires a level of rigor and safety that only a highly specialized team can provide, such as Minakem’s, trained to work with the highly toxic materials that are routinely handled.
Our Highly potent facility allows us to develop and produce HPAPIs with occupational exposure limits (OEL) as low as 0.1 µg/m3.
We implement stringent containment measures, including state-of-the-art engineering controls, to protect both our workforce and product integrity.
From the laboratory studies to commercial production, our 20+ years of expertise ensures the secure and compliant handling of highly potent APIs.
Cytotoxic and Controlled Substances
Minakem is fully authorized to handle and commercialize controlled substances, including narcotics and steroids. Our strict regulatory adherence guarantees compliance with the guidelines and product quality, ensuring safe and reliable manufacturing for the pharmaceutical industry.
R&D for Seamless Development
Our Highly potent site in Belgium is home to a dedicated branch of Minakem’s global R&D team, providing real-time support for the development, transfer, and scale-up of HPAPIs.
This smooth integration fosters close collaborations between scientists, process engineers, and manufacturing specialists, accelerating the development cycle from laboratory scale to commercial production.
Cross-Site Collaboration
Our global R&D network works in synergy across multiple locations, particularly in the areas of solid form studies, process safety, and process engineering. This close connectivity allows us to optimize processes and implement best practices efficiently, ensuring innovative and scalable solutions for HPAPI production.
Unmatched Expertise
in cGMP Preparative HPLC
One of Minakem’s standout capabilities is our specialization in High Pressure preparative Liquid Chromatography (HPLC), an essential purification technique for HPAPIs that cannot be purified by crystallization.
Our suite of LC50 to LC300 systems, as well as laboratory scale preparative HPLC systems, enables the purification of the most complex and potent compounds, under cGMP conditions, ensuring the highest purity levels for pharmaceutical applications.
By combining best-in-class HPAPI manufacturing expertise with cutting-edge purification technologies, Minakem offers a unique advantage.
Our commitment to safety, compliance, and innovation allows us to deliver high-quality solutions that meet the most demanding industry standards, supporting our partners in bringing life-saving therapies to market efficiently and safely.
