Case Study

Achieving Shorter Production Time For A Pancreatic Cancer Drug

Source: Syngene International Ltd.
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Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. The company’s initial product candidate, SBP-101, is for the treatment of patients with metastatic pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. Panbela Therapeutics, Inc. is dedicated to treating patients with pancreatic cancer and is exploring SBP-101's potential when used in combination with other agents for additional cancer indications.

The Challenge

Panbela, partnered with Syngene for the synthesis of SBP-101, a polyamine metabolic inhibitor used for the treatment of patients with metastatic pancreatic ductal adenocarcinoma.

Earlier, Panbela research team had explored a 15-step process to develop the small molecule using a literature preparation originally developed at the University of Florida. Later, Panbela partnered with Syngene for the chemical development of the same molecule (SBP-101).

Syngene’s chemical development team recommended conducting a chiral purity check of the product post-synthesis to ensure compliance with FDA guidelines.

The SBP-101 structure lacks a UV absorption signal as it consists of an aliphatic chain with two chiral centers. This makes the HPLC method development for determining chiral purity all the more challenging.

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