Complimentary technical assistance
Overcoming the COVID-19 pandemic will require rapid development of safe and effective treatments—in particular vaccine(s)—and ensuring their availability at sufficient scale.The development, approval and manufacturing of a new medicine or scaling up production of an approved therapeutic are complex. Quality-related hurdles encountered late in the development process can often slow down progress and even result in product failures. Recognizing and addressing quality challenges early in the research and development process is critical to accelerating any drug development program.
USP can offer guidance on a wide variety of therapeutics including development of vaccines, antibody therapies, antiviral therapies, immunoglobulins/convalescent plasma and scaling up production of approved therapeutics, such as secondary medications needed for patients on ventilators.
Our experts have years of experience evaluating a wide range of analytical problems and utilizing proven tests. These include tests for stability, sterility, extractables and leachables, dissolution, etc. that are required for regulatory approval. USP scientific staff can help troubleshoot on many quality-related challenges commonly encountered during development and scale-up ultimately supporting manufacturers as they advance their strategies to manage regulatory and compendial expectations.
Additionally, as scientists involved in the development, manufacture, or quality testing of COVID-19 treatments refine their drug development and quality testing, USP’s scientific expertise—combined with its breadth of quality standards, including tests, methods, and assays—can advise on:
- Regulatory expectations and analytical requirements for system suitability, control for contamination, validation
- Developing and validating analytical procedures for quality testing and detecting substandard and falsified medicines
- Qualifying raw materials to be used in manufacturing
- Safety and qualification of biologically derived/complex materials
- Supplier risk management including setting expectations based on raw material attributes and process impact
For scientific questions related to USP standards, please contact COVIDemail@example.com.
The United States Pharmacopeia–National Formulary (USP-NF) contains general chapters that provide requirements and best practices for manufacturers, regulators and laboratories that are developing, manufacturing, testing and releasing drug substances and products.
- General vaccine development and manufacturing
- Assays for vaccine validation
- Methods for nucleic acid-based vaccines
- Standards that relate to packaging and distribution of medicines