Minakem has announced that its Louvain-la-Neuve plant in Belgium has entered final qualification run to open a new closed controlled environment, high containment production facility in August.
A CDMO division of Minafin, Minakem specialise in custom development and manufacturing of building blocks, GMP intermediates and highly potent active pharmaceutical ingredients (HPAPI). The company said this high-class production facility is among only a dozen of its kind in the world; with roughly half of which located in Europe.
The new facility extends Minakem’s capacity to develop and manufacture HPAPI compounds, such as antibody drug conjugates (ADC) toxins, from small-scale development to full GMP batch releases. Unlike others in this category, Minakem’s facility will be equipped with a preparative chromatography system that allows the isolation and purification of target molecules at varying scales, from milligrams to hundreds of grams, geared to addressing a range of client needs from routine activity to analytics.
In addition, Minakem’s HPAPI production will be carried out with an Occupational Exposure Limit (OEL) below 0,1 µg/m3/8 h. This emphasis on environment, health and safety (EHS) reflects Minakem’s core business model, with experience of more than 20 years in continuously monitoring and controlling hazardous working environments.
Specialised training, adequacy of housekeeping measures and engineering controls are the pillars in the effectiveness of containment
“This new facility is a significant asset, strengthening Minakem’s position as a leader in developing and producing substantial quantities of highly potent compounds more robustly, safely and economically,” said Amadeo Ferreira, R&D manager at Minakem.
“The Louvain-la-Neuve site has handled highly potent molecules for decades. Specialised training, adequacy of housekeeping measures and engineering controls are the pillars in the effectiveness of containment. This new investment allows an increased capacity to integrate new projects as well as handle the most highly potent molecules on the market."
Ferreira continued: "These measures are requested by our customers for use in antibody drug conjugates at 10 ng/m3 levels. The entire team is proud to be part of the future generation of drugs aimed at treating cancers.”
The new facility has state-of-the-art equipment. It consists of nine fume hoods and a double-barrier of protection in the form of new generation glove boxes in room – dedicated to dry powder handling and weighing, air locks, HEPA air filters and cascading flow.
According to industry reports, the global HPAPIs market is expected to reach $26.84 billion (€22.8bn) by 2023 from $17.72 billion (€15bn) in 2018, at a CAGR 8.7%. Growth is driven in part by increased demand in oncology drugs, growing demand for antibody-drug conjugates and a growing focus on precision medicine. As a supplier to the HPAPI market, Minakem is anticipating the need for further expansion of its capacity in the next five years.
Minakem based the design of the laboratory on its own expertise and input from customers and equipment suppliers. It used a risk analysis approach to define a suitable way to work with these compounds while maintaining great flexibility.
The company anticipates that the high-performance equipment, including preparative chromatography, will increase its customers’ market competitiveness. It will start operations in the new high containment facility in September.