From bench to batch: strategies for scaling HPAPI production

July 29, 2024

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Although the small molecule market has expanded at a CAGR of approximately 5.7% over the past decade, there is even greater interest and demand for HPAPIs, with growth rates around 10.5% annually. HPAPIs have gained popularity due to their specificity and reduced side effects, resulting from their low dosage, which offers significant advantages over some older drugs. However, scaling and manufacturing these highly potent compounds present specific challenges at each stage of the upscaling process, from lab experiments to commercial production, including drying, milling, sampling, and packaging. These processes require specialized facility design and rigorous atmospheric monitoring programs.

Ajinomoto Bio-Pharma Services is well-equipped to handle these challenges. Karel Vervisch, who currently leads the company’s R&D labs for scaling late-stage products and previously managed one of the production units, share his insights during this webinar on scaling HPAPIs from the lab to production. He will discuss various aspects of the manufacturing process, including design, critical unit operations, changeover procedures, the role of an in-house toxicologist, and essential risk assessments.