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Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
It has become a tradition to recognize pharma innovation at CPhI Worldwide. This year, the prestigious CPhI Pharma Awards celebrate innovators from across four categories—formulation, packaging, process development, and partnering.
The formulation award went to MJR PharmJet GmbH for its technology that enables higher drug loading in nanoparticles. By forming counter-ion complexes, the solubility of the API can be improved without chemical alteration, allowing nanoparticles with an enhanced drug-loading capacity to be formed using the company’s microjet technology. A nanodelivery system of the cystic fibrosis drug ciprofloxacin has been developed using this technology. MJR PharmJet’s technology can be applied to a wide range of molecules and different markets, including nutraceuticals and cosmetics.
One of the finalists for this category, Aptalis Pharmatech, in partnership with ECR Pharmaceuticals, developed a once-daily formulation of the skeletal muscle relaxant cyclobenzaprine, which is usually taken three times daily. Using its Diffucaps Customized Release Technology, Aptalis managed to reduce the daily dose of cyclobenzaprine. The formulation provides extended drug release with 24 hours of coverage, delivers low rates of somnolence, promotes dosing convenience, and encourages patient adherence. This new dosage form has generated new IP protection for cyclobenzaprine in the US.
The other finalist in this category, Powder Systems LTD (PSL), on the other hand, developed a unique filtration solution for microsphere formulation, from small-scale processes up to production. The company has designed the sterile refiners to filter and classify microspheres into the micron-size range desired before drying. Accurate control of the particle size is achievable with the Microsphere Scalping &Refiner process, facilitating efficient scale-up from the R&D process to commercial manufacturing. Furthermore, the Microsphere Scalping & Refiner can achieve efficient filtration with no mesh blockage; homogenous drying with final moisture of less than 2.5% in four hours; and high yield with no product loss and maximal product offloading.
Locked4Kids BV won the innovation in packaging award with its child-resistant carton that is easily opened by seniors. Available in multiple packaging sizes, the product complies with relevant US and EU standards. Locked4Kids’ packaging consists of a carton and a tray. The tray locks into the carton when fully inserted, in which blisters with potentially dangerous products can be packaged. The packaging has ‘push points,’ placed diagonally across at a distance that adults can easily cover, but young children can’t. With the help of Ecobliss, the first reclosable child-resistant carton has been developed, using conventional cartoning machines.
Haemopharm Healthcare, was a finalist in this category for its new concept of a compounding pharmacy incorporated in a bag, the Fillchoice room. The drug can be easily manipulated and reconstituted in a completely closed system next to a patient’s bed and directly administered. This innovation replaces the standard practice of manipulating drugs in hospital pharmacies. The device’s flexibility means it can be used for any drug in any vial size and for any solvent volume. Unlike other reconstitution systems, it guarantees 100% isolation in the drug preparation system. It works similarly to a clean room, making it particularly safe for users manipulating dangerous drugs.
The finalists also included Stiplastics’ granule and tablet dispenser, which has the ability to distribute various shapes and sizes of solid forms regularly used in medicine and food supplements. The system employs a novel one-push system to deliver the exact recommended posology with a guaranteed yield of at least 98%. Stiplastics’ dispenser is made of one material (plastic), accepts variations in pill size and shape, and allows reliability and security of distribution. The system fully preserves the pills’ integrity because the medication never becomes jammed inside the device.
For process development, the winner was acib’s Catalophor System, a search engine with a database, which can discover enzyme functionalities that were previously undescribed. By finding enzymes for reactions that were previously unthinkable (enzymatically), pathways for the synthesis of totally new compounds open up new therapeutic approaches. The system can also search for enzymes that help to produce chiral molecules in pure form and alternatives to patented enzymes. By scouring approximately 100,000 database entries for similarities, the system raises a list of possible candidates. The most promising candidates are then biotechnologically manufactured and tested in the laboratory. The preliminary computer work saves countless experiments and screening, thereby increasing the opportunity to replace conventional chemical processes with environmentally friendly, enzymatic methods.
DSM Sinochem Pharmaceuticals (DSP) also made it as one of the finalists in this category. The company developed unique, proprietary, and fully backward-integrated statins processes for atorvastatin, rosuvastatin, and pitavastatin. The resulting APIs have a low level of total impurities, a superior carbon footprint (ECO+), and require fewer process steps than competitor processes. Unlike standard processes, DSM sets all chiral centers in a single aldolase-catalyzed enzymatic step, and removes the expensive and hazardous butyllithium step. In combination with selective and proprietary coupling reactions, efficient processes are obtained with a superior carbon footprint. The process for rosuvastatin has been recently scaled-up and registration batches have been made; the atorvastatin process using the same chiral intermediate has been running for several years at full commercial scale; and pitavastatin is under development.
The other finalist in the process development category was Supply Chain Strategies International (SCSI) who dared to challenge the fundamental structure of the pharmaceutical manufacturing industry. According to the company, the problem is that pharmaceutical manufacturing consists of two distinct manufacturing industries—API manufacturing and dosage form manufacturing. SCSI’s innovative approach to changing the status quo is to mirror other industries; that is, to merge the two distinct phases into one product-focused phase. The innovation eliminates the final isolation step of the API manufacturing process and instead, uses the final, purified solution of the API as the feedstock for the initial step(s) of the dosage form manufacturing process. Large, multipurpose, manufacturing facilities will likely give way to small, dedicated factories producing a single product in a continuous manufacturing train located near to markets. Supply will be controlled by the number of operation hours and cycle times will be reduced, thereby reducing inventories and supply chain risks.
Receiving this year’s innovation in partnering award is Catalent Pharma Solutions and Redwood Bioscience. Both companies have partnered to develop bioconjugates that incorporate Redwood’s proprietary FGE/aldehyde tag technology and novel bioconjugation chemistry. The SMARTag technology encompasses all the required components to produce site-specifically modified bioconjugates, including antibody drug conjugates (ADCs). The aim is to widen the therapeutic index for ADC drugs. Compared with a conventional ADC, results have shown that a SMARTag-generated ADC has a better toxicity profile, is well tolerated and provides statistically significant survival benefits, and has greater exposure and longer circulating half-life.
Codexis and GlaxoSmithKline (GSK) were also finalists in this category. The companies entered into an agreement in July this year, under which GSK is granted a licence to Codexis' CodeEvolver platform for enzyme engineering. Previously, accessing this capability was only possible on a fee-for-services basis. This arrangement enables GSK to rapidly enhance the extent to which they are able to leverage the power of biocatalysis across their pipeline, and reap the benefits in manufacturing costs, while minimizing waste production. Having Codexis’ enzyme engineering capabilities within the company also facilitates seamless prioritization and initiation of projects of interest to GSK. The licensed technology has been used to support hundreds of drug development candidates and has delivered enzymes used in more than a dozen commercial processes.
The other finalist was Solvay’sID3 with its unique open innovation model to develop customized pharmaceutical starting materials. This business model quickly addresses new customer inquiries for new active ingredients building blocks. ID3 can efficiently promote customer development from feasibility through to industrial scale, and foster responsive collaboration to improve time to market.
Source: CPhI Show Daily