From Bench To Batch: Strategies For Scaling HPAPI Production

While the small molecule market has grown at a CAGR of ca. 5.7% in the last 10 years, we are seeing even higher interest and demand specifically for HPAPIs, with growth figures around 10.5% per year. HPAPIs have become increasingly popular, as they tend to be very specific and cause fewer side effects due to their low dosage, which can be a major benefit compared to some older drugs. However, the scaling and manufacture of these highly potent compounds come with specific challenges at each step of the upscaling process, from lab experiments to commercial manufacturing, drying, milling, sampling, packaging, etc. The facilities require specific design guidelines; the unit operations need to be followed up with atmospheric monitoring programs, etc.

Ajinomoto Bio-Pharma Services has over 40 years of experience in API manufacturing and nearly two decades of HPAPI manufacturing. Karel Vervisch, who currently leads Ajinomoto Bio-Pharma Services’ R&D labs for scaling late-stage products and previously was the operational lead of one of our production units, will share our knowledge of scaling HPAPIs from lab to production. He will touch on various elements of the manufacturing process including design, critical unit operations, changeover, in-house toxicologist, and necessary risk assessments. This webinar will draw information from the learnings of our industrial hygienists and their structured atmospheric monitoring program.