Can you give an update on AFC’s activities and key milestones achieved in 2022?

2022 was a great year for AMPAC Fine Chemicals (AFC) and SK pharmteco. The company expanded both geographically and in terms of capabilities – specifically in the US, with significant investment at all our manufacturing sites as well as AMPAC Analytical. We are proud to have successfully activated and qualified our new large-scale commercial production facility in Virginia.

Additionally, we proactively invested in our technologies, equipment, and personnel to launch a “Complex Molecule Chemistry & Engineering Center” in California, supporting the rising demands for therapies with complex chemistry, synthesis, and purifications. Together, these facilities further cement AFC as a leader in solving complex chemistry challenges as it relates to impurities in chromatography.

Are there any technological areas that currently prompt more demand from customers?

AFC’s core technology differentiators include energetic chemistry, high potency manufacturing, and extensive chromatographic separation capabilities. These technologies support many new therapies with higher purity standards and challenging impurity and synthesis. AFC has decades of experience in continuous processing technology as it relates to energetic chemistry. While continuous processing is well known at the large-scale commercial stage, AFC also has the unique capability to provide validated GMP synthesis at small to medium scales. This helps bridge the gap for customers rather than having to make that big jump between small-scale clinical to commercial.

Traditionally, AFC has focused on late-stage clinical and commercial development projects; however, we are now supporting projects in earlier stages, especially those that utilize our core technologies. Our key differentiator is the speed and flexibility at which we deliver solutions – which is critical to support the increasing clinical demands following the pandemic.

Can you speak to AFC’s sustainability initiatives?

AFC and SK pharmteco have been committed to sustainability for many years and have been recognized for our advancements in green chemistry.

We are also focused on the social side. Some of our recent initiatives include STEM education programs at schools and collaborating with universities to develop core talent for the industry.

How are new technologies helping improve services in the life sciences industry?

We believe we can better serve our customers through digital processes. Having an increased focus on data allows us to improve processes while maintaining speed and flexibility to deliver products on time and in full. Capitalizing upon SK pharmteco’s digitalization capabilities, we will continue to advance our processes for the small molecule side, as well as the cell and gene side with our sister companies. We have a strong commitment to cybersecurity to ensure that the data we generate is secure and that our customers have access to what they need so they can leverage it to continue to improve their processes.

What is your assessment of the supply-demand dynamics of high-potency APIs, and broader trends for CDMOs in the US in 2023?

High potency work is increasing in all therapeutic areas. It is important to continue to be at the forefront providing a reliable supply of material to the clinic and patients. AFC continues to invest in capabilities that can support the production of high potency materials. We ensure we have the proper engineering controls in place and the process chemistry technologies to support our customers from grams up to metric tons.

We expect to see a rise in clinical demand post-pandemic, as capital markets free up and customers again start to move their clinical candidates forward. However, there are still supply chain challenges resulting from the pandemic. Being agile and flexible to respond to changing dynamics is critical. Good CDMOs have developed alternative supply chains and redundancy. Companies and industries are also starting to look at onshoring production to Western supply chains. Together AFC’s sites in California, Virginia, and Texas, along with SK pharmteco’s global network, allow us to develop customized supply chain solutions that best fit customer needs.

What are AFC’s growth strategy and objectives for 2023 and beyond?

AFC’s ambition is to continue to expand and grow to support our customers at all scales and locations with speed and agility. We will continue to strengthen our core competencies, while also expanding into new focus areas, such as in oligonucleotides and lipids.