The CDMO (Contract Development and Manufacturing Organization) business involves undertaking and conducting on behalf of clients the development of technologies for manufacturing and manufacturing processes of medicines that are essential for the prevention and treatment of diseases. As a global CDMO, AGC develops cutting-edge medicines and consistently explores future growth areas.
As a globally leading CDMO, we will continue developing drugs for the people who need them
Characteristics and breadth of AGC’s CDMO business
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AGC is one of the very few global CDMOs based principally in Japan. Operated in a tripolar fashion by Japanese, U.S. and European offices, AGC controls the entire process from a clinical trial to commercialization under a production system following cGMP (current Good Manufacturing Practice) quality standards. We also seamlessly transfer technologies among different business sites. Proposing places and timing for manufacturing to suit specific needs, we engage in extensive services encompassing development and manufacturing of microbials and mammalian products, plasmid DNA (pDNA) and cell and gene therapies.
InterviewAndrea Celia Porchia
AGC Biologics(Denmark) General Manager & Site Head CPH Site
Applying our accumulated technologies to start clinical trials and commercial production of a medicine
As a globally leading CDMO company, AGC develops and manufactures active pharmaceutical ingredients and intermediates from which to produce a medicine. As a partner of pharmaceutical and bio-venture companies, we undertake to develop and manufacture for the clinical trials and commercial and play an important role in ensuring that medicine is delivered to users without fail.
Since AGC’s core business is glass and chemistry, you may question why we have expanded our business operations into life science. Around the world, the sophistication of healthcare is increasingly diversifying needs for medicine. AGC’s strength in technological development, which we have accumulated as part of our growth strategy, may work in the field of medicine. The idea led us to start applying AGC’s technology in fluorination and to our expansion into and focus on the life science industry.
Subsequently, we expanded into biopharmaceuticals and cell and gene therapies. Currently, we also develop and manufacture mammalian- and microbial-based proteins for treatment, plasmid DNA, virus vectors and genetically modified cells. AGC’s CDMO business network spans Europe, the United States and Asia. Today, around 2,500 people are involved in the business worldwide.
Development of a new manufacturing process compatible with new modalities takes on increasing importance
In developing medicine, CDMOs play important roles in undertaking the entire process from the development to manufacturing. In particular, AGC has strength in its technologies for producing proteins from both mammalian and microbial cells. With the acquisitions and other means, we have introduced the most advanced technologies and built a biopharmaceuticals development and manufacturing capabilities within AGC.
The pharmaceutical industry continues to produce new modalities such as cell therapy, gene therapy and mRNA therapeutics. New manufacturing processes geared to these purposes are always in demand and expectations are increasing. AGC seeks to become a leader in innovation by covering a broader area of the pharmaceutical business.
AGC Biologics office in Copenhagen, Denmark
Also contributing to development of COVID vaccines
AGC has supported vaccine and therapeutic drugs development and manufacturing to help fight the COVID-19 pandemic. For example, we undertook production of adjuvant drugs which are ingredients used in enhancing the medicinal effects of NVX-CoV2373, a vaccine candidate developed by Novavax. And we manufactured plasmid DNA, a raw material for the Pfizer-BioNTech COVID-19 vaccine, from a German company BioNTech.
Quickly delivering vaccines around the world requires successful vaccine development and the design of a system for subsequent mass production. AGC has the facilities necessary for the mass production of vaccines around the world. Even though the pandemic impacted our supply chain system, we have greatly contributed in the battle against COVID because we have created a Global Continuity Committee to ensure materials for all planned API batches and secure safety stock of materials for commercial projects.
CDMOs are the next leaders in therapeutic innovation
CDMOs play central roles in developing and manufacturing medicine today. CDMOs undertaking outsourced projects support pharmaceutical companies in all stages of the process, including development, manufacturing, formulation and finishing. AGC is contributing in development and manufacturing of active pharmaceutical ingredients with medicinal properties.
We believe CDMOs can and should be leaders in developing the next treatment innovations in the orphan drug space. With extensive scientific experience in developing and scaling up to trial and commercial stages, contract development and manufacturing organizations are positioned to help create more innovations to treat rare diseases.
Developers and pharmaceutical companies that want to be successful in the orphan drug space should look for CDMOs like AGC Biologics that have the historical expertise and can offer end-to-end clinical and commercial manufacturing services, as well as the latest materials needed (pDNA, mRNA) to bring innovative orphan drugs to the market.
Streamlining commercialization processes is key to CDMO growth
Predominantly there is a need for greater agility and speed in commercial process manufacturing and execution. And Digitalization of any manufacture industry is a key step in any progress of the production process allowing to improve efficiency and productivity. CDMOs have a special digitalization challenge as there is a high complexity due to the high process variety so maintaining flexibility during implementation of processes digitalization is a specific challenge of a CDMO. Having the expertise necessary to deal with these challenges is crucial for a CDMO.
In addition, CDMOs that success must deliver product where needed and when needed on a sustainable basis. They need to meet or exceed regulatory requirements of the markets served and the customers’ expectations and this needs to be done at a fair price. To survive, CDMOs must become competitive with the lowest-cost by significantly increase productivity and efficiency and reducing the pharmaceutical company's cost of goods while making a fair profit.
CDMOs must implement best-in-class practices to significantly increase productivity and efficiency such as Lean Six Sigma to eliminate waste and reducing variability, utilization of cost-effective technology which will also drive efficiency and productivity and capacity utilization which will also generate major efficiency and productivity improvements.
