Parenteral & Lyophilized Clinical Trial Materials

//Parenteral & Lyophilized Clinical Trial Materials
Parenteral & Lyophilized Clinical Trial Materials 2018-02-23T12:13:35+00:00

From clinical scale development to full commercialization, VxP Biologics develops innovative and timely solutions throughout the entire life cycle of drug development, respecting your confidentiality every step of the way and helping you get a quality product to market.

As a cGxP facility, we are committed to providing the highest quality standards in the industry. We also understand how important it is that special care must be taken to ensure all equipment and processes are performing to specifications. We pay special attention to equipment qualification and process validation to provide complete regulatory compliance for our small molecule manufacturing clientele. We have the capabilities to develop and execute validation protocols required for your processes and equipment in accordance with cGMP guidelines.

Validation Services

  • IQ/OQ/PQ/PV and utility qualification packages
  • Environmental controls and monitoring
  • Terminal sterilization procedures
  • Aseptic processing
  • Cleaning validation
  • Process validation

The aseptic manufacturing team supports clients with process development, cGMP manufacturing, and formulation of the API. With demonstrated manufacturing experience of over 100 cGMP lots of drug substance, we understand that successful cGMP production requires seamless integration of process and analytical development, product formulation, and regulatory (QA) management. At VxP Biologics, you have all of these groups working together to support your products.

In addition to the production of your bulk API, the complementary drug product manufacturing facilities provide you with an integrated end-to-end resource. As your program advances in the clinic, you’ll be confident knowing that we have the resources to efficiently scale-up your production requirements without changing facilities. Optimizing the capacity eliminates the need for redundant technology transfer and qualifications. With this fully integrated development and manufacturing resources, we can support your program from concept to vial.

Process Development

The process development group can develop and validate an entire process or optimize individual steps in a previous process to ensure the entire process is suitable for manufacturing in a cGMP environment. From early-stage process development to final cGMP manufacturing, the aseptic manufacturing team works in sync with dedicated analytical chemistry groups to ensure product integrity throughout every step of development.

Formulation

Whether your drug substance is destined for bulk storage or finished product, we will formulate your product to the specific needs of your molecule and development program. At VxP Biologics, we have extensive experience with highly potent, cytotoxic, and complex formulation processes.

Whatever your project, we can provide quick and customized solutions for:

  • Blending/homogenization
  • Filtration
  • Filling
  • Container/closure selection
  • Lyophilization
  • Manufacturing Scale-up and Technology transfer
  • A wide range of analytical and testing services
  • Cytotoxic and complex formulations

cGMP Production

The cGMP manufacturing facility can manufacture a variety of small and large molecule drug products. The parenteral formulation team has experience with essentially all drug product types and administration routes.

After initial cGMP production, we have the capabilities to efficiently scale-up the process to meet larger volume requirements for your product. The experienced teams can rapidly advance your product candidate through the clinic and onto the market by providing you with the necessary equipment and analytical testing every step of the way.

All areas of the aseptic processing facility are routinely monitored for viable and non-viable contamination via airborne and surface methods by the QC Microbiology Laboratory. Additional support is also included by the full service Analytical Chemistry Laboratory and Quality Assurance Department.

Contact us today for a free consultation with the scientific team and discover how VxP can be a valuable resource and partner for your organization.