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December, 23 2024

cGMP to GLP-1: Compounding Pharmaceuticals

With the new year arriving fast and resolutions being made, many around the world – and their physicians – are looking to add “weight loss” to the top of the list. Fortunately, recent developments in pharmaceutical weight loss have led to new discoveries regarding a naturally developed hormone that could be the key to unlocking everything from accelerated weight loss to insulin management: Glucagon-like peptide-1 (or GLP-1). These discoveries have resulted in the explosion of new popular drugs such as Ozempic and Wegovy, but the science behind these new semaglutide drugs is proving to be much more than a fad.

The Complexity of Compounding Pharmacies

The science behind GLP-1 is complex with potentially groundbreaking implications in pharmaceutical manufacturing. Simply put, GLP-1 as a hormone is created by enteroendocrine L-cells, the pancreas, and the central nervous system to specifically interact with receptors, labeled GLP-1R. These interactions stimulate the pancreas to release insulin, triggering insulin receptors in the body, which determine the amount of glucose to absorb from the bloodstream. This can affect blood sugar levels and maintain appetites. However, the issue of weight loss is layered, and ultimately unique on an individual basis.

The Demand for Compounding Pharmacies

What is the best way to address such an individualized issue? Compounding pharmacies and manufacturing. While compounding pharmacies are faster to respond to provided results, there is still a lengthy process to endure compared to traditional manufacturing. After thorough testing, results are sent in the form of a unique prescription, which is then processed using sourced materials and bespoke quantities before being sent back to the patient. All of this is performed in highly regulated, sterile environments.

The rising popularity of GLP-1 medication is also leading to increased demand worldwide, and manufacturers are struggling to keep pace. With GLP-1 solutions garnering more acceptance, its viability as a solution for those with diabetes must be considered. According to a study observing the growth of diabetes over time, the number of youths affected by Type 1 and 2 diabetes will skyrocket by 20601. If true, manufactured GLP-1 solutions are as critical as they are timely, with up to 44 million potentially benefitting from the drugs2.

With the U.S. market for weight loss research and development reaching a potential $41 billion by 20333, compounding pharmaceutical facilities will likely multiply globally. Whether the facility is classified as a 503A (Pharmacy) or a 503B (Outsourcing Facility), each must adhere to either strict state regulations or strict(er) cGMP/FDA processing guidelines to ensure a tightly controlled sterile environment. As such, the potential for an industry-standard EPA-registered decontamination is limitless.

As the potential for GLP-1 medication grows, pharmacies will follow suit, attempting to meet the demand. With an established history in existing pharmacies, SteraMist ionized Hydrogen Peroxide (iHP) is uniquely qualified to deliver the speed and control for sterile environments at every step of the process – from material storage and equipment decontamination to upstream and downstream processes. Natural science and six-log and greater kill using the sole active ingredient of hydrogen peroxide and cold plasma technology introduce a versatile solution at up to four times the speed of competitors – with no surface damage. Partnering with multiple compounding pharmacies, SteraMist meets the increasing demand for quick, premium decontamination. Is your compounding pharmacy up to code? Adhering to decontamination is crucial for safety, compliance, and meeting regulations. If you need assistance, contact us today. If you are a patient exploring GLP-1 medication, do not skip the research. Find out where your medication is made and what decontamination standards are in place. It’s your health – be informed.

References:

  1. https://diabetesjournals.org/care/article/46/2/313/148151/Projections-of-Type-1-and-Type-2-Diabetes-Burden
  2. https://www.techtarget.com/pharmalifesciences/feature/Are-compounded-GLP-1-drugs-safe
  3. https://www.custommarketinsights.com/report/us-weight-loss-market/