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Akihiro Kadokura of AGC Pharma Chemicals: the CDMO's industry edge and sustainability commitments

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Akihiro Kadokura, CEO of AGC Pharma Chemicals, started his career in global project management of AGC including six years assignment in the US, and has since progressed to various management positions in global health care companies over the last 20 years. He returned to AGC Chemicals in 2018 and has been CEO of AGC Pharma Chemicals Europe since March 2019.

AGC Pharma Chemicals is an international contract development and manufacturing organization (CDMO) that makes small molecule active pharmaceutical ingredients (APIs) and intermediates across its production sites in Spain and Japan. 

With 40-plus years as a CDMO, 60-plus years as an API manufacturer and over 100 years as a chemical company, AGC Pharma Chemicals is a world leader in fluorinated compounds, providing pharmaceutical companies with reliable, high-quality products and agile, flexible development and manufacturing processes thanks to its team of chemical R&D experts and extensive technological equipment.

Here, Akihiro Kadokura shares his thoughts on the current challenges for the pharmaceutical industry and explains AGC's commitment to sustainability.

You are a leading CDMO with over 40 years’ experience, but what is your industry edge?

We are experts in developing and manufacturing APIs and intermediates and our roots as a chemical company also make us leaders in fluorinated compounds with our own source of raw material. This allows us to handle the entire supply chain from raw materials to final APIs.

One of our strengths is also our reliability and our track record speaks to it: we have had no FDA 483 observations for over 20 years and no critical or important findings from the EMA or Japan’s PMDA.

The agility and flexibility of our team, facilities and multi-purpose factory sets us apart from others. What makes us unique is a speedy decision making process because we have every function in one site in Spain. In addition, our quick turnaround in delivering high-quality molecules of any structural complexity using our innovative approaches and cost-efficient, sustainable solutions (e.g. digitalization).

Our expert chemists carefully devise and validate synthetic routes that are safe to be performed for scale-up, from grams to tons, in our R&D and kilo labs, pilot and multi-purpose plants, and micronizers to achieve the best drug performance.

Also, our continuous improvement by Lean/Six Sigma approach also contributes to future cost competitiveness. All our employees receive ongoing training in the Six Sigma model we have been following for 18 years.

On top of that, last April we announced an investment of €90M to expand the Barcelona plant. The new facilities will have reactors of between 1.5 and 7.5 cubic meters to step up the production of APIs, a market that is growing at 7% per year, and additional space for other group investments going forwards. Our HAPI assets will also be included in the new site. It will boost production capacity by 30%, with a new 7,500 sq meter facility, and create 100 new jobs. We have also recently invested in the R&D laboratory, GMP Kilo lab, and micronization capacity. Both Kilo lab and Micronizer can operate HAPIs (OEL band 1-10µg/m3).

Thanks to the financial stability of AGC Group, we are constantly expanding our capabilities and capacities.  

Industry requirements and demands are increasingly stringent. What other steps have you taken around compliance and security? What is your view on the state of the industry in this area?

As part of a highly regulated and competitive industry, it is essential for CDMOs to invest in continuous improvements to processes, facilities, and equipment to guarantee quality. The need for digital processes and methodologies is increasingly evident. It is critical for the industry to maintain data integrity across all production stages while also delivering on speed and flexibility in material and product manufacture. That is what all the improvements in our facilities are aimed at. For example, one core digitalization project in Barcelona involved the implementation of an electronic batch record (eBR) fully connected to and integrated with the Distributed Control System (DCS).

We overcame the concept of ‘paper on glass’ by automatically extracting process data and synchronizing it with the manufacturing guide. It provides real-time production information, with continuous monitoring and alerts for critical parameters. At the same time, it ensures compliance requirements and data integrity, by applying the ‘review by exception’ concept, which consists of reviewing only the alerts generated during manufacturing.

You have received the EcoVadis Platinum medal this year. Could you tell us more about the company’s commitment to sustainability?

We are committed to doing business sustainably. For this reason, we operate responsibly to reduce our footprint. We are constantly evaluating processes and identifying and reducing the impact of all our activities. I believe that having indicators and constantly monitoring performance are critical to controlling our environmental footprint. We have cut emissions in recent years to help reach the corporate target of a 30% reduction by 2030.

Our efforts were recognized by EcoVadis, the world's most trusted business sustainability rating, which indeed awarded us its Platinum medal in July 2022. This is a recognition that goes only to the highest one percent of the companies assessed, so we are proud of it.

Why did you choose Spain, and specifically Barcelona province, to set up your chemical plant in Europe?

Our manufacturing sites are in Spain and Japan, both developed countries with very strong pharmaceutical markets. This makes us conveniently located for local and global customers. The Barcelona facility is just 90 minutes from France and Catalonia is known as the chemical and pharma industry heartland of Spain. The region has excellent talent and the people who work here are highly experienced and customer-oriented. We are very proud to have these profiles in both countries.

What are the main challenges for the pharmaceutical industry in the short term?

After COVID-19 and because of the current international situation, one of the main concerns of the market is to ensure a safe and agile supply chain. Therefore, the trend – and the challenge – is to count on a source in Europe (not in a low-cost country), even if it is a starting material. Our process development and scale-up capability can contribute to this challenge. Our qualified R&D chemists can create and validate synthesis routes and implement innovative approaches to find cost-efficient solutions.

For the scale-up, thanks to our multi-purpose plant and equipment such as R&D Lab, Kilo Lab, Pilot and a micronizer, among many others, we can offer agile and flexible production ranging from grams in R&D to tons in the production plants. This capability also meets another market demand, as customers want to work with fewer suppliers and to outsource multiple services and/or products to a single CDMO.