GLP/GMP For Macromolecules

///GLP/GMP For Macromolecules
GLP/GMP For Macromolecules2013-02-04T10:53:31+00:00

VxP Pharma provides an array of development and production services for recombinant proteins, antibodies, plasmid DNA, cell therapies and vaccines for preclinical, clinical and commercial use.  The technology and expertise allow for rapid turnaround times and the most cost-effective solutions in the industry.

Supported Biologics:

  • Recombinant proteins
  • Antibodies
  • Plasmid DNA
  • Cell therapies
  • Vaccines

The biologics manufacturing team supports clients with cell banking, 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 Pharma, you have all of these groups working together to support your product.

In addition to the production of your bulk 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.

Process Development

The biologics 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.  Up-stream, the process development group can screen multiple production strains to select a cell line that provides the best possible expression of your drug substance.  We can optimize processes, such as high cell density fermentation, to increase product yield and manufacture the best quality product in the most efficient and cost-effective way possible.  While creating a manufacturing process suitable for your cGMP production, the process scientists can develop optimal fermentation and product recovery processes, as well as downstream purification steps.  From early-stage process development to final cGMP manufacturing, the biologics manufacturing team works in sync with the protein analytics 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 complex formulation processes.  We have expertise in aseptic processing and formulation of liposomes, nanoparticles, conjugates, crystallized proteins, protein concentration/buffer exchange, adjuvants, and viscous products.

The supported formulation equipment for biologics:

  • Single use mixing systems
  • Temperature control with heating or cooling
  • Tangential flow filtration
  • High pressure fluid processing (homogenizers and microfluidizers)
  • Other static mixers
  • Sterile filtrations (syringe filters to capsule filtration)

cGMP Production

VxP Pharma’s cGMP manufacturing facility can produce plasmid DNA and protein products for vaccines in Phase 1-2 clinical studies.  With VxP Pharma, you’re not just partnering for the scalable fermentor capacity up to 1,000L, but also for the opportunity to use the demonstrated expertise and experience through an extensive track record of multiple cell banks and production lots of cGMP biologic drug substance.

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 microbial fermentors and equipment every step of the way.

Cell and Virus Banking

The establishment of compliant, robust, and traceable cell and viral banks is critical for meeting cGMP production guidelines.  Banking of master and working cell banks (MCB, WCB) for mammalian cells are performed in a separate area designed for these activities. Viral banking services are completely segregated from non-viral activities to ensure no cross-contamination of products.

Mammalian Cell Banks:

  • Base master & working cell lines (e.g. HEK-293, Vero)
  • Stable recombinant protein/antibody expressing lines (CHO, NS/0, BHK-21)
  • Human and non-human stem cells

Viral Cell Banks:

  • Viral Seed Stocks – Viral vectors for gene delivery (adenovirus, retrovirus, lentivirus, AAV, and others)
  • Viral vectors for vaccines (live, attenuated, and whole-killed)
  • Banking/vialing of purified phage

*Quality assays for release of all banks are performed by outside testing firms to ensure safety and stability of these products. 

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.