GLP/GMP For Small Molecules

///GLP/GMP For Small Molecules
GLP/GMP For Small Molecules 2013-02-04T10:52:52+00:00

From product research to full commercialization, VxP Pharma develops innovative and timely solutions for both manufacturing and product development; respecting your confidentiality and helping you get a quality product to market.

As a cGMP facility, we are committed to providing the highest quality standards in the industry.  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 your 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 Pharma, you have all of these groups working together to support your product.

In addition to the production of your bulk API drug substance, the complementary final drug manufacturing facilities provide you with finished product in vials.  As your program advances in the clinic, you’ll be confident knowing that VxP Pharma has 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 these fully integrated development and manufacturing resources, we can support your program from concept to vial.

Process Development

The process development group can develop 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 the analytical chemistry group  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 Pharma, 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
  • Highly Potent Compounds

cGMP Production

VxP Pharma’s cGMP manufacturing facility can manufacture a variety of small molecule drug products.  The parenteral formulation team has experience with essentially all types of administration routes, including:

  • Solutions
  • Dispersions
  • Suspensions
  • Emulsions
  • Liposomes
  • Nano-particles

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.

The state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.

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.