With 30 years of expertise, Marin Bio’s stability services focus on the delivery of quality bioactivity stability data to support every stage of the product development lifecycle from  development, qualification/validation, through IND and NDA/BLA stages and for commercial pharmaceuticals.

Marin Bio provides a controlled and documented course for all our stability studies, with precise record keeping and reporting.

  • Unmatched quality
  • Prompt timeliness
  • Cost-effective solutions
  • Exceptional communication

We interact directly with the FDA, ensuring regulatory compliance and supporting our clients at every step.

 Stability studies ensure that drugs remain safe, effective, and high-quality throughout their shelf life. 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) under a variety of storage and environmental conditions resulting in recommended storage conditions, retest intervals and expiration dates. The drug physical, chemical, biological activity, among other characteristics are assessed. 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. This information is crucial for regulatory compliance, formulation and packaging, and maintaining patient safety as well as support supply chain logistics.

Need Help or Have Questions on GLP/GMP Services?

Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study,  lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services

We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.

Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.

MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.

Need help or have questions on cell based assays?

Give us a call at 415-883-8000

What Are Stability Studies?

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.

MarinBio Platforms for Stability Studies

The experimental methods performed at MarinBio test the bioactivity of manufactured drug lots over time under various conditions, such as temperature (-80oC, -20oC, Room Temp, or accelerated studies at 45oC) and at high humidity. For preclinical or clinical samples, such as serum or plasma, stability must be determined for shipping conditions and for multiple freeze/thaws or other storage.

The storage vessel, whether polypropylene, polycarbonate, syringe composition, also impacts the stability. Additional treatment of the pharmaceutical, such as selection of the matrix impacts the stability. MarinBio performs different assays (see links below) depending upon the drug and client request.

Case Study

Potency of a Drug Substance (DS) Stability Sample by a Potency Assay: Cell Proliferation Assay

Assay method: This assay is used for the release and stability testing of a Drug Substance (DS) and Drug Product (DP). It evaluates the effect of drug material on the proliferation of GMP-banked test cells. In each assay, the test sample is compared to the DS Reference Standard (RS).  Factor dependent CTLL-2 cells are maintained in Interleukin 2 (IL-2) growth factor. On day 0, cells are washed and cultured overnight without growth factor.  On day 1, cells are cultured with serial dilutions of Reference Standard and test sample, all conditions are analyzed in triplicate.  Proliferation at day 4 is measured by CellTiter Glo (Promega), a measure of intracellular ATP, with a readout of relative luminescence, see graph below. The results are analyzed by a Four Parameter curve (4P) fit. This results in the effective concentration of the maximum response,  (EC50), values for each sample found on the x-axis. The relative potency (RP) of the test sample relative to the reference standard on the same plate is calculated, RP = [EC50 RS] / [EC50 Test]. A test sample with a weaker potency than RS requires a higher concentration to reach its EC50. 

A graph comparing the relative luminescence units of a stability sample and a reference standard over a range of log ng/mL values.

Contact Us about Our Stability Testing Services

For More Information about our cell based assay services, please use the following informational form