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The scale-up is usually performed at a scale of 10-100 grams and is a vital step to determine whether the process developed in the laboratory can be successfully scaled up to larger production volumes without compromising product quality or consistency. Identification of any technical or operational challenges that may arise during full-scale production, as well as troubleshooting and optimization of the process, should be performed before large investments are made.
Most importantly, data generated from the scale-up/demo batch, including process parameters, yields, and impurity profiles, support the tech transfer to manufacture the product on scale and the regulatory submissions for pharmaceutical approvals.
We typically perform our scale-up and demo batch synthesis in our kilo-lab to prepare the required quantities of product using the developed manufacturing process. We also routinely ship samples of single-batch intermediates for analytical process research & development.
We provide robust science and peace of mind in demo batch execution, combined with thorough tech transfer documentation, allowing our clients to gain valuable insights, speed up familiarization, minimize risks, and improve overall manufacturing processes, ultimately bringing their portfolio to market faster.
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