Assurance of Quality Supply - For Single-Use Solutions

Complete Control of Our Entire Supply Chain - Best-in-Industry

The uptake of single-use in biomanufacturing and the shift from clinical to commercial production require enhanced Assurance of Quality Supply (AoQS). Our industry leading AoQS is built on partnerships, quality agreements and supply contracts with our suppliers to achieve tight specifications and controls of our resins and films. The control of our entire supply chain and manufacturing process is your best guarantee of consistent quality, change control and business continuity.

The Challenge

Growing Adoption of Single-Use Solutions in all Process Steps of Commercial Production Requires Enhanced Assurance of Quality Supply

The supply chain for Single-Use Solutions is complex and can impact all 3 components of Assurance of Quality Supply

  • Lack of transparency on supply chain & quality systems
  • Variability of raw materials
  • Demand doubling every 3–4 years with more complex designs

Our Solutions

Consistent Quality | Robust Change | Control Business Continuity

AoQS is Built on Partnership & Relies on the Full Control of Our Entire Supply Chain

  • Material science, quality by design (QbD), film extrusion, bag making and product design expertise‘s are the foundations of AoQS
  • AoQS is built on partnerships, supply contracts and quality agreements with our suppliers of raw materials, films and components
  • AoQS relies on the control of our entire supply chain & manufacturing process from the resins to the final single-use solution

We Lead the Single-Use Industry with Our Level of Control of Resin Formulation and Film Extrusion

Unlike other suppliers, we combine resin specification, extrusion design space & control of the entire process.

Levels of ControlResins SpecificationResins Control Extrusion Design SpaceExtrusion Control
S80 & S71YesYesYesYes
Other FilmsYesYesNoYes
NoYesYesYes
NoNoNoYes
NoNoNoNo

Bioplan

Each change in raw material cost 100,000 €.

Resin Specifications, Process Controls, Long Term Contracts &

Resin specification & control

  • Resin & additives traceability
  • Lot-to-lot raw material consistency

Long term contract

  • 2 year last time buy option
  • 2 year stock of resin & film

Extrusion design space & control

  • Consistent cell growth & robustness
  • Lot-to-lot consistent extractable

10 year supply & quality contract

  • 2 year last time buy option
  • 2 year stock of resin & film

Long term supply contracts

  • 2 year change notification

Quality Agreements

  • Bioburden, particle & endotoxin
  • Extractable characterization

Business continuity plan

  • Back up equipment & safety stocks
  • Double clean room footprint by 2020

Multiple manufacturing sites

  • 7000 m2 of ISO7 clean room WW
  • Resin-to-bag process control
  • 4 year guarantee of unchanged film
  • 2 year guarantee of unchanged components for our Pre-Designed-Solutions

We Offer Best AoQS with our Level of Control of Resins, Films...

Consistent Quality

  • Our industry leading AoQS is the result of building partnerships and establishing quality & supply agreement with all our suppliers

Robust Change Control

  • These collaborations help achieve the specifications and controls of our resins, additives and films

Long Term Business Continuity

  • The control of our entire supply chain and manufacturing process is your best assurance of consistent quality, change control and business continuity