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Case study : Varleigh Immuno-Pharmaceuticals

Case Study March 2013

Background and Challenges:

VarleighImmuno-Pharmaceuticals Ltd. (Varleigh) is a British clinical stage biotechnology company focused on immune and inflammatory disorders. The company is focused on developing anti-complement and anti-inflammatory molecules as treatments for a range of conditions within the autoimmune and inflammatory diseases market.

Varleigh’srecombinant protein drug product requiredcGMP manufacture under aseptic conditions to produce clinical supplies. Having previously suffered a total batch loss and with very little drug product remaining,Varleigh were keen to engage a reliable supplier with experience in small sterile batches.

There was significantcommercial imperative for Varleighto urgently dose patients in order to secure the company’s next milestone payment and thereby ensure the continued financial viability of the company, a common challenge for biotechnology companies.

Investigation into the previous batch failure had indicated degradation of the drug product occurred due to the use of Vaporised Hydrogen Peroxide (VHP) in the CMO’s isolator decontamination regime. Many naturally occurring biologicals are super sensitive to oxidation after exposure to even trace amounts of hydrogen peroxide residue. Symbiosis does not use Vaporised Hydrogen Peroxide in any of its manufacturing operations.

Varleigh had a very limited amount of drug product (165.85g) with which to manufacture clinical trials supplies. Their drug product had to be sterile fill finished (0.55g / vial), with minimal loses and no biochemical degradation.

Solution Delivered:

The team at Symbiosisworked closely with Varleigh to understand the challenges posed by the producttoidentify a suitable manufacturing process.When working on a closed system i.e. one that offers the greatest aseptic assurance, there will always be “hold up” or “dead” volumes that cannot be recovered. By designing and assembling a custom liquid drug filling rig Symbiosis were able to reduce and minimise the volume of drug solution lost as part of thefilling process.

The system “hold up” volume was minimised to just 21.2g, exceptionally good for such a small starting volume. From this, 263 vials were filled and overlaid with a nitrogen gas backfill to protect against biochemical degradation.Twenty six vials were irretrievably used as part of the manufacturing process due to standard in processes losses including weight checks, visual inspection, and line prime, etc.In terms of filling accuracy,Varleigh specification was for a fill weight control with a 0.055g band however the process exceeded expectations by delivering with a 0.02g band.Theoutput of 237 vials delivereda conversion rate of 79%, an excellent yield for such a small starting volume.

What VarleighImmuno-Pharmaceuticals said: “Symbiosis demonstrated an ability to meet our requirements for a very small number, low volume fill without losing much material. They had excellent responsiveness to this problem” – Dr Wynne Weston-Davies, VarleighImmuno-Pharmaceuticals Ltd.

For small biotechnology companiesfollowing securing capital the major challenges are to buildstrategic partnerships with both investors and suppliersthat facilitates the execution of development programme in accordance with agreed timelines and milestones.The tenacity of Symbiosis to overcome the manufacturing challenges, against pressing timelines and to deliver the project on budget meant that Varleigh had material available to progress through clinical trials and continue developing treatments for disabling diseases with limited or no effective treatment options.

VarleighImmuno-Pharmaceuticals Ltd. is a clinical stage biotechnology company focused on immune and inflammatory disorders. The company is focused on developing anti-complement and anti-inflammatory molecules as treatments for a range of conditions within the autoimmune diseases market and the much larger inflammatory diseases market with a value in excess of $10bn.

Symbiosis Pharmaceutical Services is a leading small-scale contract manufacturer of novel injectable pharmaceuticals for use in clinical trials. We specialise in the phase I and phase II GMP manufacture of liquid, lyophilized, cytotoxic, conventional and biological pharmaceuticals.

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