Speed in market: how to be agile once you’re there

How can filling technology help you produce in line with market demands? Reduce tech transfer times? By being agile and enabling scale out manufacturing models.

“The thing about forecasts is that they are by definition wrong—whether up, down, or sideways—but I don’t know by how much. Agility is a countermeasure to uncertainty. It can improve speed to market and speed in the market when things change.”

Esteban Santos
Executive Vice President, Operations, Amgen

You could be in any position in biopharma manufacturing—in development, in the clinic, ready to launch or well into commercialization. At any of these points, you wrestle with the uncertainty of the forecast, of market conditions, of competition.

Here are some data around those uncertainties:

  • Bain & Co. estimated that 50% of all pharma product launches in the peak sales range did not meet expectations and half of those missed by more than 50%. The effect of those misses is under- or over-supply, one of which leaves money on the table, and the other results in  millions or billions of dollars in inventory.
  • The oncology pipeline includes 748 drugs in late-stage clinical development yet it is likely that only 70–90 oncology products will launch over the five years 2019-2023.
  • More than 1,000 biosimilar candidates are in development or the clinic, fracturing blockbusters into smaller pies around the world in the coming years.

Your aseptic filling strategy can give you a strategic advantage, but it has to be done right.

Agility for multi-product manufacturing

If you’ve already chosen Vanrx, your experience has been or will be reaching GMP readiness sooner than with conventional filling technologies.

But when you pass validation, an aseptic filling machine needs to be agile to cope with all of these uncertainties. Agility means being capable of filling multiple container types with short changeover times. Our closed robotic workcells are highly integrated combinations of robotics, closed “gloveless” barrier isolators and advanced automation.

For the SA25 Aseptic Filling Workcell, agility is switching between vials, syringes or cartridges and decontaminating the system in an hour. For the Microcell, it’s switching between small volume drug products in vials in 30 minutes.

With these systems in place, your production schedule could look like this:

To support agility, there’s a supporting ecosystem that removes friction from your day-to-day operations:

  • Recipe-driven automation built into a single human-machine interface (HMI). It surprises some people that have been doing this for a while that there isn’t separate HMIs for the filling machinery and barrier system.
  • Integrated VHP decontamination and clean-in-place (CIP) systems to support rapid and safe changeover.
  • Single-use flow paths, filling needles and environmental monitoring supplies. No need for the time, risk and supporting infrastructure of multi-use components.
  • Nested, pre-sterilized containers and closures, so you do not have to run washing and depyrogenation machines in the ramp up to filling.

Our drive to create these products came from being responsible for aseptic filling at biopharma companies, both internally and with CDMOs. Our responsibilities crossed between clinical and commercial drug products, and we were early to recognize that the nature of pipelines had shifted to highly targeted and complex therapeutics, including biologics, cell & gene therapies and other high-value, low- to medium-volume therapeutics.

The challenge has shifted from running fast in a straight line, to running shorter distances fast, but in multiple directions.

Strategic agility is to scale out

It may be controversial at first, but your aseptic filling needs are not unique. You want a robust aseptic process that maintains the safety of patients and the efficacy of your drug products. So why do companies redesign the aseptic process every time by going the modular or custom machine route?

Scaling out is best solution for strategic agility in aseptic filling. It makes more sense to pick a standardized machine with flexibility built-in, designed by experts for sound sterility assurance. Buy one, then another one, and then another. After one or two, you will be really good at running them. Every machine will be installed, validated and running faster.

Roche / Genentech is doing exactly this. They selected the SA25 Aseptic Filling Workcell as the global flexible filling platform to meet the current and future needs of their pipeline. In presenting at conferences, the company said this “network strategy” for aseptic filling will drive down their tech transfer times, increase the speed of drugs to market and lower their cost of goods.

WuXi Biologics, the global CDMO, is going down the same path. They are cloning their initial SA25 cleanroom to provide scaled out services for their global biologics customer base. In doing so, machines can be allocated to the clients with the greatest need, and with a high utilization rate too.

How can you reach GMP faster?

As discussed in another blog, there is a significant cost associated with lengthy timelines for a company to reach GMP operations.  This blog asks how that process can happen faster.

References:

  1.  McKinsey & Company. Operations as a competitive advantage in biotechnology. URL: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/operations-as-a-competitive-advantage-in-biotechnology.
  2. Iqvia. The Global Use of Medicine in 2019 and Outlook to 2023.
  3. GlobalData Biosimilars Database, 2020.