The Tech Group

With the prevalence of Non-alcoholic Steatohepatitis (NASH) rapidly increasing globally, West is working with its pharmaceutical partners to support their development of new injectable treatments for this serious liver condition. However, there are many challenges associated with trying to bring new treatments to market.

As noted previously, certain drugs require cold storage in order to maintain efficacy for delivery to patients.  A well-monitored cold chain can help to ensure that drugs are properly handled throughout storage and transportation. But how can a manufacturer prove that the drugs are maintained and controlled adequately in a cold environment?

Temperature sensitive drug products, such as biologics or insulin, often require cold storage. But what, exactly is “cold”?  We know it when we feel it, but often when one person is shivering, another is quite comfortable. Like humans, drug products may have specific tolerances to cold that depend upon the product.

The rise in type 2 diabetes has sparked a variety of treatment options, including glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1s are a class of injected drugs (additional oral options are currently in development) that “mimic the action of GLP-1 and increase the incretin effect in patients with type 2 diabetes, stimulating the release of insulin.”¹ Commonly used when oral treatment alone is not enough, the benefits of GLP-1s include a reduction of glucagon and glycosylated haemoglobin (HbA1c), weight loss and a low risk of hypoglycemia.²

When left untreated, diabetes eventually can lead to a variety of issues for patients, including complications such as stroke, blindness and heart and/or kidney disease. In addition, adherence to painful or inconvenient injection treatments can be difficult for patients, with as many at 57% of Type 1 and Type 2 diabetes patients admitting to intentionally skipping injections.¹