11.25.25 -- Considerations In Sterility Testing And Assurance

Tailored drug release is evolving from formulation tactic to precision therapy strategy, optimizing timing, site, and rate of delivery for improved patient outcomes.

Examine the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.

Headspace analysis offers a non-destructive way to assess CCI by detecting gas ingress. It’s versatile across product types and formulations, with proven effectiveness in identifying leak defects.

Compliance with EU GMP Annex 1 requires a strategic CCS. Review how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.

Medical and pharmaceutical products are often packaged in fluid-filled containers. Read about CCIT using high voltage leak detection (HVLD), how HVLD technology works, and more.

Learn how to identify a reliable CDMO partner with services suited for your project’s needs and the capability to help you efficiently navigate the path to market.

Gain insight into a disposable autoinjector for Tirzepatide that supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.

See how digital twins revolutionize pharma manufacturing by enhancing bioprocess efficiency, ensuring compliance, leveraging AI and IoT, and safeguarding product quality.

Optimizing pDNA production in E. coli requires strategic media selection and scale-up planning. Explore a study that identifies ideal conditions for high-yield manufacturing.

The peptide manufacturing industry is evolving to meet the demands of efficiency, scalability, and sustainability. See how the latest innovations are addressing these challenges.

Discover how Liquid Phase Peptide Synthesis (LPPS) uses traditional reactors to create more efficient and sustainable peptide manufacturing. Learn about key analytical and quality control considerations.

Industry 4.0 is revolutionizing CDMOs and CMOs. Find out how AI, IIoT, and automation are driving smarter, faster, and more compliant manufacturing to ensure agility, precision, and innovation.

Here, we demonstrate how adding small amounts of mesoporous silica to Cholesterol before jet milling can enhance processing efficiency, boost yield, and improve micronization performance.

While clinical efficacy is the critical benchmark for any drug program, ensuring manufacturability is also vital. An experienced CDMO can help you establish efficient and cost-effective production strategies.