In a pharmaceutical industry constantly striving for innovation, one category of substances is gaining prominence: HPAPIs (Highly Potent Active Pharmaceutical Ingredients). Primarily used in the treatment of serious illnesses such as cancer and autoimmune diseases, these compounds are redefining manufacturing and analytical standards.
But what truly characterizes an HPAPI, and what challenges are associated with their handling? FILAB Laboratory offers insights into these molecules with high therapeutic value.
What is HPAPI? Understanding the challenges of highly potent active ingredients
Definition: what is an HPAPI?
A HPAPI is a pharmaceutical active ingredient capable of producing a biological effect at very low doses. In practice, these molecules often have a very low occupational exposure limit, generally less than or equal to 10 µg/m³, meaning that even minimal exposure can pose a health risk.
These substances include, in particular, cytotoxic agents (oncology), hormones, certain narcotics, and newer antibody-drug conjugates (ADCs).
The rise of HPAPI in modern medicine
Pharmaceutical companies are increasingly turning to these molecules for several reasons:
- high therapeutic efficacy at very low doses
- potential reduction of side effects for patients
- development of targeted therapies, particularly in oncology
Today, a significant proportion of new drugs rely on this type of compound, especially for treating cancers or certain complex diseases.
The challenges of handling HPAPIs: containment and security
The potency of these molecules is a double-edged sword. While they are beneficial to the patient, they represent a major risk to operators and the production environment in the event of even minimal exposure.
Security (OEB)
To manage these risks, the industry uses containment levels called OEB (Occupational Exposure Banding). The higher the level (OEB 4 or 5), the more drastic the protective measures must be: isolators, closed transfer systems, specific personal protective equipment (PPE) and rigorous cleaning protocols.
Preventing cross-contamination
In a multi-product plant, the risk of cross-contamination is significant. Trace analysis and cleaning validation become essential steps to ensure that no HPAPI particles end up in another batch of medication.
FILAB laboratory's expertise in the analysis of active ingredients
The handling and analysis of HPAPIs requires not only state-of-the-art equipment but also a rigorous methodology. At the FILAB laboratory, we support pharmaceutical companies in the characterization and control of their APIs:
- Development and validation of analytical methods (according to ICH Q2) to accurately quantify these substances at very low thresholds.
- Detection of impurities according to ICH Q3D and of degradation products to guarantee the stability and purity of your most sensitive compounds.
- Surface and powder analysis (morphology, particle size) to optimize the formulation of highly potent drugs.
- Extractable and leachable studies to ensure that the final packaging does not react with the potency of the active ingredient.
What analytical techniques are used for HPAPI analysis?
The analysis of HPAPIs requires methods capable of detecting and quantifying substances at extremely low levels while ensuring the reliability of the results.
In practice, several complementary techniques are used in the laboratory:
LC-MS / LC-MS/MS: reference method for identifying and quantifying traces of active ingredients or impurities.
HPLC / UHPLC: a method widely used for quantification, impurity profiling and stability studies.
GC-MS: a method suitable for the detection of residual solvents and volatile compounds.
ICP-MS: method used to detect elemental impurities in trace amounts.
To conclude
The future of pharmaceuticals lies in HPAPIs (Highly Phytosanitary Products for Individuals). While their therapeutic potential is immense, their complexity demands flawless analytical expertise. As an independent laboratory specializing in chemical analysis and materials testing, FILAB puts its know-how at the service of the safety and compliance of your most demanding projects.
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