Q&A: CARBOGEN AMCIS dedicates new site to sterile liquid drug manufacturing

by ,

As CARBOGEN AMCIS opens its doors to a new sterile liquid drug product manufacturing facility in Saint-Beauzire, France, EPM caught up with Pascal Villemagne, CEO of CARBOGEN AMCIS, to discuss what this will mean for CARBOGEN's capabilities in freeze-dried products.

The new site is dedicated to the custom development and production of sterile injectable drug products. Built on newly acquired land located 7km from an existing CARBOGEN AMCIS site in Riom, the new facility increases product development and manufacturing capacity for liquid and freeze-dried products for pre-clinical and clinical trials as well as small-scale commercial use.

The 9,500m2 facility will be home to approximately 100 highly-skilled employees and create 50 new jobs throughout 2023.

Q. What will the opening of the new injectable and sterile drug product manufacturing and development facility mean for CARBOGEN AMCIS capabilities?

CARBOGEN AMCIS provides specialist drug development and commercialisation services to the pharmaceutical and biopharmaceutical industries across all stages of drug development. For more than 40 years, we have supported the pharmaceutical industry to bring new drugs to market to improve human health.

In February 2023, we opened a new state-of-the-art facility in Saint-Beauzire, France dedicated to the custom development and production of sterile drug products. These products are subject to stringent regulation.

CARBOGEN AMCIS has over 15 years’ experience in this area and our new site will add two fully automated production lines for liquid and freeze-dried drug products. These have been designed to handle any type of liquid form, including the most potent compounds and antibody drug conjugates.

This unique set up enables the manufacturing process to be more streamlined and flexible. It will ultimately increase customer access to these products, helping the roll-out of new and better treatments, which help improve patients’ quality of life or treat otherwise terminal illness.

Q. What are the current/emerging trends in injectable drug products, and how will CARBOGEN AMCIS’ expansion meet the demand?

The global injectable drug delivery market size was valued at $483.45 billion in 2019 and is projected to reach $1,251.28 billion by 2027, fuelled by the unique ability of these injectables to deliver medication to the target site more efficiently and effectively.

This rising demand for effective and convenient systems of drug delivery poses a distinct opportunity for manufacturers to develop sophisticated, consumer-friendly methods of administering treatment.

Over the last six years, CARBOGEN AMCIS has expanded its facilities and increased productivity to meet the growing demand for sterile injectable drug products, particularly antibody drug conjugates.

The fully automated nature of the two production lines at our new site means that the company will be able to meet increased demand efficiently and effectively, and diversify its offering into new disease areas.

Q. What are some recent advancements in the field of liquid and freeze-dried drug products?

In recent years, the pharmaceutical industry has invested heavily in developing new treatments for cancer. Here at CARBOGEN AMCIS, we are supporting this investment by leveraging our world-class chemistry skills to provide seamless injectable drug product development and manufacturing. We have developed a range of cGMP (Current Good Manufacturing Practices) compliant liquid and freeze-dried drug products specifically for the oncology market.

By capitalising on the 15 years’ experience, we have in the development of safe injectables and liquid pharmaceutical forms for a wide range of indications, our new facility will be a key enabler in meeting the demand for injectable drugs.

Q. What do you think is driving the current trends of freeze-dried drug products?

Freeze-drying uses low temperatures and processes called sublimation and desorption to extract moisture. This doesn’t affect chemical or physical properties and preserves biological activity. For the pharmaceutical industry, where many products and specimens are fragile, unstable and heat-sensitive, this preservation technique is ideal.

After a product has been freeze-dried it’s suitable for storage and transport at room temperature for long periods of time. Adding water is all that’s needed to reconstitute the product. The capacity to stabilise products – which is particularly important for Active Pharmaceutical Ingredients – and increase the shelf life of drugs and medications makes freeze-drying one of the most widely used techniques in the pharmaceutical industry.

The process of freeze-drying is complex but here at CARBOGEN AMCIS we have the tools and the technical ability to do this. Our new facility will enable us to undertake large-scale production of freeze-drying cycles for our clients.

Q. What are the benefits of small-scale manufacturing and will this be something we see on the rise?

Pharmaceutical medicines are developed for specific patient groups, from large-scale vaccine programmes right down to rare diseases and medication for the individual. Small scale batch manufacturing defines batch sizes up to around 5,000 units and orphan drugs and personalised medicines require these ever-smaller production quantities. The new facility that CARBOGEN AMCIS has opened is uniquely set up to provide a flexible and compliant environment to produce smaller, targeted quantities.

Q. Anything else to add?

Securing fill finish capacity can be a challenge for many pharmaceutical companies but at CARBOGEN AMCIS we support customers at every stage of a product’s life cycle.

This impressive new facility will better enable us to respond to customer needs from the initial development of a drug substance to commercial fill and finish.

Watch construction videos of the New Drug Products Facility  and Teaser Riom 2.