Stability Studies

Stability studies occupy a critical niche within drug development. Scientists design stability studies to assess products' physical, chemical, and microbiological stability under various environmental conditions. By subjecting products to controlled stressors, such as temperature, humidity, light, and pH, Ascendia’s teams aim to predict how drugs will degrade and change over time. These tests allow pharma. biotech and biological companies make informed decisions about formulation, packaging, storage, and other commercial considerations.

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rigorous stability testing protocols

Ensuring the Safety of Pharmaceuticals and Biologics

Stability studies are particularly essential within the pharmaceutical industry. Pharmaceuticals must maintain their potency, efficacy, and safety throughout their shelf-life. Doing so is vital to ensure patient safety and regulatory compliance.

Stability studies help pharmaceutical companies determine optimal storage conditions, expiration dates, and product packaging materials. By monitoring factors such as degradation of active pharmaceutical ingredients (APIs), formation of impurities, and changes in physical characteristics, stability studies enable CDMOs and pharma manufacturers develop formulations that remain stable and effective over extended periods. These are hallmark attributes of robust product development and commercialization.

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Quality Assurance

Maintaining rigorous quality standards is paramount in pharmaceutical manufacturing. When outsourcing stability studies, ensuring that these entities adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) is essential. There's a risk of compromising quality if the CDMO fails to meet regulatory requirements or follow standardized protocols.

Regulatory Compliance

Outsourcing stability studies requires thorough vetting of the CDMO’s compliance with regulatory standards to ensure that the data generated will be acceptable for regulatory submissions.

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Communication and Collaboration

Effective communication and collaboration between the pharmaceutical company and CDMO are critical for successful stability studies. Clear communication channels, defined responsibilities, and regular updates are necessary to ensure project timelines are met and stakeholders address any issues or deviations.

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Risk Management

Outsourcing introduces inherent risks, including delays. Pharmaceutical companies must proactively identify and mitigate these risks through comprehensive risk management strategies. The process may involve conducting due diligence assessments and performing site audits. A CDMO should welcome these evaluations to prove their ability and value.

Determine the robustness of formulation prototypes during early development.

Ascertain the chemical and physical integrity of lead formulations before advancement into animal/toxicology studies.

Assure final formulations meet stability requirements for clinical trials and commercial products as companies transition formulations to human studies.

Reach Out Today

Partnering with Ascendia for your stability studies empowers you to confidently make informed decisions, mitigate risks, and bring high-quality pharmaceutical products to market.

Contact us today to learn more about how Ascendia can support your stability testing needs and drive the success of your pharmaceutical development programs. Let us be your trusted partner in ensuring the stability and safety of your products.