Parenteral Product Development and Phase I and II Clinical Manufacturing

Element is at the forefront of pharmaceutical development and manufacturing of parenteral formulations, providing parenteral product development and Phase I and II Clinical Manufacturing services to the global pharmaceutical industry.

Parenteral solutions and emulsions are complex formulations both in how they release the drug into the body and how they are formulated to be effective for their intended use and remain stable over time.

Due to these products bypassing the body’s natural defenses, they must be exceptionally pure and free from contaminants, posing a continual challenge to pharmaceutical companies that manufacture such products.

Element offers parenteral Chemistry, Manufacturing, and Controls (CMC) product development and clinical manufacturing services that help you meet the stringent requirements and specifications that are enforced by the Food and Drug Administration (FDA). These services include:

• Pre-formulation and formulation development
• Clinical batch aseptic manufacturing (Phase-1 and Phase-2)
• Analytical development and validation
• Microbiological development and validation
• Filter validation bacterial retention studies
• Sterilization and depyrogenation development and validation
• Container/closure compatibility and integrity testing
• Lab-scale and clinical batch manufacture
• Batch release and ICH stability testing
• Environmental monitoring
• Media fills
• Master batch records
• Packaging and labeling
• Technology transfer
• Development of technical and regulatory documentation

Working with Element

Our highly-knowledgeable scientists guide you through the development of stable parenteral products, from determining the degradation profile of the drug to conducting stability studies, process compatibility and scale-up.

We take special care to ensure that micro-organisms and other extraneous materials are not present, safeguarding the quality and safety of your product. Our goal is to help you develop safe, stable and effective injectable products that comply with ever-expanding regulatory requirements.

To learn more about our parenteral product development and clinical manufacturing services, or the services we provide to the pharmaceutical industry,contact ustoday.