Stability studies are performed to ensure that pharmaceutical products will be at the acceptable level of quality throughout the period that they are available in the marketplace and fit for consumption by the consumer up to the expiry date.
ICH and FDA stability studies are essential for drug product development supporting IND/NDA/BLA submission activities. Stability programs evaluate the active pharmaceutical ingredient (API) and/or drug product (DP) (including drug packaging) under a variety of storage and environmental conditions resulting in recommended storage conditions, retest intervals and shelf lives. If the API or DP degrades or inactive products (matrices) leads to loss of efficacy, the ramifications are inappropriate activity of the drug, possible side effects or toxicities.
Stability testing varies with time under various physical, chemical or microbiological changes, temperature, pH, humidity, light and radiation. Stability programs typically include real-time stability storage and may include accelerated stress (relative high temperatures and/or humidity) and forced degradation studies. For example, usual practice for retained storage are analyzed typically at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months, if the API or DP has a 5-year shelf life. Testing containers and closures at different orientations, either upright or inverted, determines whether the drug product can extract chemicals from the closure components or the drug product adsorbs to the container.
Test methods are carried out using validated assays for specificity, accuracy, precision, linearity and range as well as limits of detection and quantification. Marin Bio offers stability testing services with comprehensive expertise in the areas of small molecule, large molecules, proteins, DNA, RNA, and viruses for the pharmaceutical and biopharmaceutical. Marin Bio’s stability services focus on the delivery of quality stability data to support every stage of the product development lifecycle from inception, development, qualification/validation, through IND and NDA/BLA stages. Furthermore, Marin Bio provides a coherent, controlled and clearly documented course for all our stability studies, with precise record keeping and reporting.
MarinBio has many years of experience in developing and validating potency assays for stability studies.
When you require an assay to prove your science and there is no commercial kit available, you need a custom assay. MarinBio’s extensive expertise enables rapid and methodical development of your assay for eventual validation. Typically, a custom assay can be developed from the inception to a completed bioassay in 5 or less experiments, while minimizing any effects of the matrix.
MarinBio expert at preparing and validating GMP/GLP or research level cell banks. The banks could include primary cells or cell lines for specific bioassays, as well as cell bank uses for production, isolation and characterization of genetically defined clonal cell populations and small-scale manufacturing of biologic products.
MarinBio professionals have vast experience with improving cell culture growth, freezing, serum-free culture, cloning for client bioassays, as well as transfection with DNA or RNA and/or liposomes (lipofection) for genetically variant cell lines as well as for gene or protein expression bioassays.
Our scientists have developed over 200 custom bioassays involving growth, toxicity, transfection, cell surface, cytokine or gene expression. We are your scientists; MarinBio will make your GMP potency lot release assay or drug screening assay.
Many companies planning an IND submission or in Phase I/II may only require a well-qualified assay, rather than a fully validated assay. You may or may not need GLP/GMP stringency and auditability. The expert MarinBio scientific team works with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy, with validation in mind for the future.
To validate an assay, the precision, linearity, accuracy, robustness, system suitability and repeatability is measured to meet acceptance criteria. We in-source your assay or fully develop and validate an assay to meet the FDA GLP or GMP requirements.
When patient samples or drug product samples need analysis, MarinBio will map out a timeline and follow through with sample receipts, meeting your regulatory needs at all points. We perform your assay as a developed, qualified or validated bioassay, and promptly communicate the results and/or provide a Certificate of Testing for any or all of your pre-clinical or clinical phases.
Knowing the importance to the FDA of lot release potency testing data, our professional scientific team tests every manufactured lot with your assay and provides Certificates of Testing.
In order to determine shelf-life for a particular drug substance, stability tests are performed at pre-determined calendar intervals. MarinBio’s expert project coordinators communicate closely with you to anticipate the arrival of samples in order to be prepared for timely analysis and the submittal of data and Certificates of Testing.