“We find that the closer a company is to commercialization, the more agnostic they are to location. However, if a molecule is in the early stages of clinical trials, interaction between ourselves and the client is essential and so proximity becomes a more significant factor.”
AGC Biologics was created following AGC Asahi Glass’ acquisition of Biomeva and CMC Biologics. Could you provide an overview of how the three organizations have been integrated?
Following the acquisitions of CMC Biologics and Biomeva, we began to identify how to integrate all entities under the single AGC Biologics brand. There are a number of challenges that come with rebranding because all stakeholders need to be accounted for. Thus, we carried out a thorough integration period across nine different streams, including operations, quality, I.T. and supply chain. We also developed a strategic plan to grow the business. We had an ambitious capital investment approach, which included expansion at our Denmark facility in order to support the demands from current and potential new customers. This included additional bioreactor capacity to support customers that are developing orphan drugs and niche products. Moreover, we are now the largest microbial CMO in Japan. The Japanese market needed a CMO to carry out mammalian manufacturing to both E.U. and U.S. standards, and we are currently building the first facility of its kind in Japan, which should be ready by Q3 2019. Even at this early stage, we already have a lot of client interest. Moving forward, we also plan to expand our microbial commercial capacity in the United States.
AGC Biologics has successfully manufactured more than 200 biological projects, from pre-clinical studies through commercial approvals. With the acquisitions, we now have manufacturing facilities at a variety of scales for mammalian cell culture and microbial fermentation in Berkeley, California and Seattle, Washington as well as in Heidelberg, Germany, Copenhagen, Denmark plus Yokohama and Chiba, Japan.
What differentiates AGC Biologics’ service offering from the rest of the market?
We are one of the best CMOs working with orphan drugs and smaller products in the biologics space. Getting these types of products approved in mammalian manufacturing systems is challenging, but we support our customers by finding the best solutions for them as they prepare to launch their products. We see ourselves as more than just a manufacturer; we are partners to guide our customers through regulatory issues and FDA/EMA concerns, as well as assisting with product launch and managing inventories. Companies need a lot of support, whether they are small or large, and that is what we do well. We have 12 late-phase products within our portfolio that we are working to get to market within the next three years. Very few contract service companies in this space have commercialization capabilities and can take a client all the way to market.
What sort of biopharmaceutical companies are you serving and where are they geographically situated?
Smaller companies have always been a significant part of our business strategy and we have seen this increase during the past year. The market is favorable for smaller biotechs and they have been receiving significant financial support from investors and the larger biopharmaceutical companies. With respect to a company’s given geography, each facility serves customers from around the world. For the client, it is about the right fit for the product rather than proximity. We find that the closer a company is to commercialization, the more agnostic they are to location. However, if a molecule is in the early stages of clinical trials, interaction between ourselves and the client is essential and so proximity becomes a more significant factor.
Could you elaborate on your proprietary technology - CHEF1?
We have been working on CHEF1 for several years. It is an expression system that is flexible, stable and fast in developing cell lines. We can develop cell lines in a 12 to 14 week period, which is a key advantage for our customers. Moreover, the system is well recognized by regulatory authorities. There are currently four products that have been approved that used CHEF1, and many more in clinical trials. We ensure that cell lines are not a limitation for approval. Its yields and stability are what sets it apart.
How do you ensure quality standards are met across your multiple facilities?
We operate under a similar quality system and we have integrated this approach across all of our operations. However, it goes beyond that. We make sure all our team members in different offices share their best practices. We also encourage the exchange of personnel between sites so they can learn from each other and improve their own work environments.
What are your key objectives for 2019?
We want to continue our growth strategy, which will be propelled by the high level of interest in our manufacturing capabilities for commercial products. We will also have some exciting investment announcements for Q1 2019. With respect to inorganic growth, we have been actively looking at M&A opportunities in the cell and gene therapy space, which is a key growth area for AGC Biologics moving forward.
Do you have a final message to new potential U.S. clients?
We are looking for small or mid-size customers with a mammalian or microbial product to bring to market. We are able to support our clients through the launch phase, scale up and the delivery of the product to market in the best way possible. We are the right partner that will be able to assist them from the earliest to the final stage.