Pharma Stability: Insights, Guidelines, and Expertise
ICH Q1A(R2) outlines stability testing requirements for new drug substances and products. It provides standardized guidance on study design, storage conditions, test frequency, timepoints, and analytical expectations.
Click to read the full article.
Small molecule drugs are chemically synthesized, low-molecular-weight compounds with well-defined structures. Examples include paracetamol, metoprolol, and atorvastatin.
Click to read the full article.
In protocol planning, a risk-based approach means assessing potential risks to the quality and safety of the drug product during its shelf life — and tailoring your testing strategy accordingly.
Click to read the full article.
The molecule under discussion is a 150-kDa IgG1 monoclonal antibody expressed in CHO cells, purified using protein A chromatography. The final dosage form is a 1 mL pre-filled syringe with polysorbate 80 as stabilizer, stored at 2–8°C.
Click to read the full article.
The product was a glycosylated IgG1 mAb expressed in CHO cells and filled in 1 mL prefilled syringes with citrate-phosphate buffer and polysorbate 80. Its intended storage was 2–8°C, with excursions to room temperature anticipated during distribution. Several formulation-specific risks were identified:
Click to read the full article.
Unlike adults, pediatric populations — especially neonates and infants — have unique physiological and metabolic characteristics that influence how drugs are absorbed and tolerated. As a result, pharmaceutical companies often reformulate adult drugs into pediatric-friendly versions, such as:
Click to read the full article.
A Master Protocol Template (MPT) is a standardized document framework used to draft individual product-specific stability study protocols. It contains:
Click to read the full article.
Understanding the difference between an amendment and a deviation is the first step in maintaining documentation integrity:
Click to read the full article.
Stability protocols are legal documents that form part of regulatory submissions and product dossiers. Any mistake in sampling frequency, testing method, or specification range can impact the product’s shelf life or lead to a regulatory audit finding.
Click to read the full article.
ICH has divided the world into four climatic zones based on temperature and humidity, which impact the degradation rate of pharmaceuticals:
Click to read the full article.