Between 10.00 and 12.50 today, the six finalists of the CPhI Innovation Awards will deliver their presentations at stand 51D02. Each company will have 20 minutes to present its innovation and the winner will be chosen by the judging panel, which will be chaired by Hendrik Baumann of CU Chemie Uetikon.
Between 10.00 and 12.50 today, the six finalists of the CPhI Innovation Awards will deliver their presentations at stand 51D02. Each company will have 20 minutes to present its innovation and the winner will be chosen by the judging panel, which will be chaired by Hendrik Baumann of CU Chemie Uetikon. The rest of the panel will comprise Zoran Buncic (Pliva), Didier Bensoussan (Dr Reddy’s Laboratories, UK), Hans-Leonhard Ohrem Merck KGaA), Andreas Stolle (Saltigo) and Michael Platscher (Merck and Cie). With the excpetion of Dr Platscher, the panel has remained unchanged since 2007.
The results will be announced at the Exhibitor’s Party, which will be held later today in the Europa Hall (from 17.30 to 19.30). Results will also be available in the organisers’ Wednesday Show Daily.
By the time you read this, the presentations will probably already be underway. Here’s a short summary of each of the entries.
The first presentation will be Johnson Matthey with its Catalysts’ Colour-Tag-Protein (CTP) technology, which has been developed to be an efficient marker for protein expression. When fused to a protein of interest using genetic methods, the tag acts as a direct marker for protein expression.
Because the method is so simple, it can be used in automated high-throughput screening for optimising production conditions. According to Johnson Matthey, the technique was used to determine the optimum expression conditions for the company’s X-Zyme libraries of alcohol dehydrogenases and resulted in expression levels being raised by an average 500%.
With biotechnology being increasingly used when synthesising chiral molecules, it is important to optimise this process to reduce production times and costs. Using the CTP allows even small protein quantities to be quantified in crude extract cells. In addition, unlike the commonly used expression marker green fluorescent protein, CTP can be used in both aerobic and anaerobic conditions.
Glycotope’s presentation on its GlycoExpress platform technology will be second. The platform has been designed to optimise the glycosylation of antibodies and other glycosylated biotherapeutic, and is based on a set of human cell lines. Human biotherapeutics are often made in mostly E.coli, yeast or cell lines derived from insects or rodents, which can cause immunogenic reactions, but GlycoExpress provides a set of human glycoengineered cell lines that differ only in the patterns they create. Glycoproteins expressed in these cells are available in various glycoforms and bioassays enable identification of the pattern that provides the best product characteristics.
The cell line has already been used in the company’s own clinical pipeline so it approved by various regulatory authorities in Europe.
Acuris will talk about a disposable drug delivery device for the continuous delivery of small-volume parenteral drugs. The device can deliver doses ranging from microlitres to millilitres per hour. Being driven by osmotic actuation, the device has no battery or other power supply, and no electronic or mechanical components. It delivers a precise, stable flow rate as the osmotic drive compensates for the dilution process. In addition, it uses standard components, such as prefilled cartridges and syringes. It can be used for both subcutaneous and intravenous administration, and is also suitable for use in MRI investigations because it contains no ferrous materials.
Small-volume parenteral drugs comprise a considerable amount of the molecules in pharma development so there is a growing demand for appropriate delivery devices. Acuros’ device can be disposed of after a single use and the company believes it is the only small-volume infusion pump that is fully disposable and takes advantage of standard prefilled cartridges.
3M Drug Delivery Systems
The fourth presentation will be delivered by 3M and will focus on the company’s Integrated Dose by Dose counter. This enables patients using metered dose inhalers (MDIs) to plan for when they need a new one by allowing them to track he status of their medication. The device was designed in response to a recommendation from the FDA that sated that MDIs should enable patients to track the number of remaining doses. To gain insight into what patients wanted from inhalers, 3M commissioned an in-depth qualitative research programme.
Accuracy is essential when designing dose counters and the 3M device uses a displacement driven mechanism that operates just prior to spray release, which makes undercounting impossible and minimises the potential for over counting.
Another important feature of the inhaler is that it can be used with existing packaging lines.
Gerresheimer will present its high-performance vial, which is based on multilayer technology and suitable for parenteral use. The vial is constructed from a combination of the plastic cyclic olefin polymer (COP), which is compatible with sensitive drug formulations, and polyamide, which provides improved barrier properties compared with vials made of COP or other polymers alone. The polyamide is encased by COP, meaning that only COP comes into contact with the drug solution.
The multilayer design ensures vial performance and also increases impact resistance by five or 10 times compared with glass vials. In turn, this helps minimises breakage during processes such as filling, crimping and transportation. The impermeable and puncture-resistant polyamide layer also increases shelf life (oxygen-barrier properties are 30–40 times better compared with polymer monolayers) and makes the vials suitable for highly potent products.
Further advantages of the vials include compatibility with existing rubber closures and seals, and the fact that they retain the transparency of glass thanks to the process of injection blow moulding.
The final presentation will focus on PANATecs’ P-Check. Based on fluorescence resonance energy transfer (FRET) technology, P-Check detects whether materials are contaminated with protease. If protease is presence, the system splits the substrate peptide and emits a fluorescence signal. It can detect most known and unknown proteases, and this range can be extended using an additional peptide library.
Many different proteases can be found in the raw materials used in enzyme immunoassays and these can affect assay performance. Proteases can also impact biopharmaceutical products and patient safety.
For known proteases, P-Check is sensitive in the nanogram range, and protease activity in contaminated materials can, to some extent, be suppressed using various chemical inhibitors, or using thermal treatment. In addition, the technique is suitable for controlling incoming protein-based raw materials for enzyme immunoassays and optimising protease inhibitor use.