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Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.
On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.
On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards. Winners were recognized for their innovative solutions in formulation, process development, packaging, and partnering. The first three category winners were selected by a panel of judges representing industry and academia, while the latter, which was a new category this year, was determined by voting on the CPhI Pharma Awards website. The winners included MJR PharmJet in the Formulation category, ACIB (Austrian Research Center of Industrial Biotechnology) for Process Development, Locked4Kids for Packaging, and Catalent for Partnering.
Innovation in formulation
Technologies considered for the innovation in formulation category can be related to drug delivery, excipients, controlled release, stability, or bioavailability. The three finalists included Aptalis Pharmaceutical Technologies for its Diffucaps customized drug-release technology, Powder Systems Ltd. for its advanced microsphere formulation technology, and the winner MJR PharmJet for its counter-ion technology, which enables higher loading of hydrophobic drugs in nanoparticles for more effective delivery.
Using its Microjet reactor technology, PharmJet generated a self-assembled, equimolar counter-ion complex of the antibiotic ciprofloxacin with sodium dodecyl sulfate (SDS) via formation of electrostatic interactions between the sulfonyl group of SDS and the tertiary amine of ciprofloxacin. The complex, which exhibited higher solubility in organics, was then dissolved with biodegradable poly(lactide-co-glycolide) and precipitated against water, again using its MicroJet reactor technology, to obtain nanoparticles with the desired particle size and much higher drug loading. The nanoparticles can be further formulated into a pulmonary treatment for cystic fibrosis infections due to its higher antibiotic load. The Microjet reactor technology can also be applied to a wide range of drug molecules to increase bioavailability and effectiveness, according to the company.
Innovation in process development
Technologies evaluated in the process development category relate to synthesis techniques, crystallization methods, polymorphism control, catalysts, and the use of green chemistry. Finalists for the 2014 award included DSM Sinochem Pharmaceuticals with new statin compounds, Supply Chain Strategies International with new approaches to pharmaceutical manufacturing, and the winner ACIB for its Catalophor system for discovering new enzyme functionalities.
Unlike typical bioinformatics techniques that generally seek similar amino acid sequences to identify homologous enzymes, the ACIB system identifies enzymes using specific three-dimensional templates of active site geometries and chemical functionalities associated with specific activities (catalophores). The system is comprised of a proprietary search engine and the Protein Data Bank, which contains more than 100,000 proteins. It can also search public databases for new enzyme structures. The search generates a list of possible candidates that contain the desired active site characteristics, avoiding the need to run large numbers of screening experiments. The most promising are then synthesized and tested. This approach is attractive because it creates the opportunity to identify enzymes that operated via previously unknown reaction pathways, thus enabling more environmentally friendly methods for the synthesis of both known and completely new compounds, including chiral molecules.
Innovation in packaging
New technologies considered in the packaging category must be related to primary packaging, devices and technology, patient compliance, dispensers, materials, or anticounterfeit systems. The finalists for the 2014 award included Haemopharm Healthcare for its Fillchoice room, a compounding pharmacy incorporated in a bag for use in a hospital room, Stiplastics for its granule and tablet dispenser for the distribution of various shapes and sizes of solid forms, and the winner Locked4Kids BV, for its child-resistant carton.
Locked4Kids, an initiative of Ecobliss, is designed to protect small children from accidental poisoning. The carton contains a tray that holds blister strips. Hooks on the tray insert into openings diagonally positioned on two sides of the carton, resulting in automatic locking of the tray when it is fully loaded into the carton. The hooks, which are placed too far apart for children to reach but easy for adults to manage, must be simultaneously pushed to unlock the tray. The reclosable carton meets the requirements for child-resistant packaging in the United States and Europe and can be mass-produced in multiple sizes using existing manufacturing equipment.
Innovation in partnering
The new partnering category focuses on partnering methods, novel uses of technology, unexpected outcomes, and unique relationships. The finalists for the first award in 2014 included the licensing of Codexis’s CodeEvolver protein engineering platform technology to GlaxoSmithKline for the development of new enzymes, the new collaborative ID3 innovative business model for the development of customized pharmaceutical building blocks from Solvay Aroma Performance, and the winner, Catalent Pharma Solutions, for its collaboration with Redwood Bioscience on the development and application of SMARTag bioconjugation technology. Catalent brought to the partnership its expertise in biologic development, advanced GPEx expression system, and biomanufacturing capabilities, while Redwood Bioscience contributed its proprietary conjugation platform, advanced cytotoxin-linker chemistry, and ADC development expertise.
Unlike conventional heterogeneous cysteine and lysine conjugation, the SMARTag site-specific system produces homogeneous antibody drug conjugates (ADCs). An antibody (mAb) containing an inserted formylglycine generating enzyme (FGE) recognition sequence is produced in a cell line that over-expresses FGE, which mediates formylglycine (an aldehyde) formation during sulfatase biosynthesis. The result is the production of an aldehyde-tagged mAb, which is purified using standard processes and then subjected to site-specific conjugation with a proprietary cytotoxin-linker system that reacts selectively with the aldehyde tag. The aldehyde tags can be placed at multiple positions in the antibody in order to maximize ADC performance without affecting its aggregation behavior or other properties, and the linkers are suitable for use with a variety of payloads. Compared to conventional ADCs, a SMARTag-generated ADC has a better toxicity profile, is well tolerated and provides statistically significant survival benefits, and has greater exposure and a longer circulating half-life, according to Catalent, which in early October 2014 acquired the remaining stake in Redwood Bioscience. The company believes that the new bioconjugation technology will lead to the development of bispecific ADCs and ADCs for indications beyond oncology.