Speed to market: what’s the benefit of being early?

If you could reach GMP filling readiness two years earlier, what would it mean to your company’s bottom line? The success of your product launches?

Vanrx provides a faster path to reaching GMP manufacturing. Here are some of the highlights, comparing to conventional filling machinery with RABS or isolator barrier systems:

  • Standard machine designs for faster built and installation times, eliminating the design and integration stages of projects;
  • An aseptic process designed by pharmaceutical manufacturing experts to emphasize flexibility and sterility assurance, i.e. no modular systems and no design / redesign by committee;
  • Smaller Grade C cleanroom space that is faster and cheaper to build; and
  • Can build machine in parallel with modular cleanroom facilities and deliver a complete facility in months, not years.
Standard machine designs, smaller cleanroom requirements at a lower classification (Grade C), simpler utility requirements, standard qualification and validation protocols and other elements make Vanrx Aseptic Filling Workcells the fastest option to bring filling facilities online. (Image credit: Singota Solutions)

Data to validate this approach

Here are some data points to support this approach to reaching the market faster:

  • Over the past three years, the average time from purchase order to factory acceptance test (FAT) is 26 weeks. Compare that against 12-15 months for conventional systems.
  • In the same period, customers averaged 7 weeks from the completion of FAT to Site Acceptance Test (SAT) completion.
  • Customers routinely reach GMP within 12-15 months of their purchase order with multiple vial, syringe or cartridge formats validated. CDMOs WuXi Biologics and Singota Solutions are good examples of this trend.

What’s the cost of being early vs. late? 

To put a number on the cost of differing market entries let’s examine the graph below.  When comparing the available barrier technologies for aseptic filling we can see a similar cumulative cash flow in the first two years of each project as they work toward GMP manufacturing.

This model assumes you have a portfolio of products ready to manufacture, or are moving to launch new products. With Vanrx, you reach positive cash flow earlier and with less risk of going over budget and over your project timeline. Between month 12 and month 18 of your project with us, you have passed validation and are producing drug products for human use.

With Vanrx’s standard design and rapid lead time, that GMP milestone is reached earlier than the other projects.  Shaving off two years from the time it takes to start generating revenue would be in anyone’s best interest. 

And what is the scenario of being late? Your company has missed out on all of the benefits of being early. You have probably overspent your budget and possibly underperformed in a product launch versus competition.

The need for speed does not end once your operations are up and running.  How do you quickly adapt to dynamic market conditions?  Have a read in one of our other blogs about the need for agility.