Sitting Down with Christian Schneider, Director Of
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APRIL 2016 # 18 Upfront In My View Business Sitting Down With Reducing the manufacturing Why pharma must address Can small biotechs bear the Christian Schneider, costs of gene therapies environmental discharges burden of innovation? Director of NIBSC 10 17 48 – 49 50 – 51 www.themedicinemaker.com We’re Backing Batch Pharma is investing in continuous manufacturing for the future, but batch-based processing is the here and now! From powder to coated tablet and from R&D to full-scale Designed with integration in mind, you can select from a variety manufacturing, no other supplier offers such a comprehensive of standard process modules to suit your project needs. Plus, as range of batch-based technologies for oral solid dosage form containment experts, we not only offer the largest portfolio of production. Whatever your application, no matter how contained processing solutions, we can assist with the selection challenging, GEA’s powder handling, granulating, drying, process and optimise your entire production line, making it compression and coating solutions will meet and exceed efficient, safe and cost-effective. Contact [email protected] your individual requirements. today for more information or talk to an expert at POWTECH (booth 3A-237) or INTERPHEX (booth 2421). gea_batch_ad_medicine_maker.indd 2 24/03/2016 15:00 Online this Month Controlling Crystallization lecturer in the Department of Chemical Engineering at Imperial College London, We all know that crystallization is crucial UK, and focuses on understanding the in the pharma industry when it comes role of surface properties in particle to manufacturing active pharmaceutical engineering. Recently, he has examined ingredients (APIs) – and on page 12 of the feasibility of establishing template- We’re Backing Batch this issue you can read a snapshot about induced polymorphic domains for API the fascinating work from Jerry Heng crystallization. You can read a Q&A Pharma is investing in continuous manufacturing for the future, and his team, who hope to be able to give with Heng online. manufacturers greater control over the but batch-based processing is the here and now! crystallization process. Heng is a senior http://tmm.txp.to/0416/Heng Better Bioprocessing From powder to coated tablet and from R&D to full-scale Designed with integration in mind, you can select from a variety The Medicine Maker recently manufacturing, no other supplier offers such a comprehensive of standard process modules to suit your project needs. Plus, as teamed up with GE Healthcare to Matt Hutchings (University of East range of batch-based technologies for oral solid dosage form containment experts, we not only offer the largest portfolio of learn more about the trends and Anglia, UK) – who is studying bacteria production. Whatever your application, no matter how contained processing solutions, we can assist with the selection challenges of bioprocessing. You found on South American leafcutter challenging, GEA’s powder handling, granulating, drying, process and optimise your entire production line, making it can read a collection of interviews ants in the hope of discovering new compression and coating solutions will meet and exceed efficient, safe and cost-effective. Contact [email protected] covering topics such as extractables antibiotics – has come up with a list and leachables, vaccine production, of weird and wonderful places where your individual requirements. today for more information or talk to an expert at bioprocessing bottlenecks and more scientists are seeking new microbes and POWTECH (booth 3A-237) or INTERPHEX (booth 2421). in the online supplement. the drugs they produce. Check out our infographic online. https://themedicinemaker.com/ Around the World in issues/0316/bioprocess-insights/ 80 Microbes http://tmm.txp.to/0416/Hutchings www.themedicinemaker.com gea_batch_ad_medicine_maker.indd 2 24/03/2016 15:00 Contents 21 48 03 Online This Month Upfront In My View 08 Mega-Merger Not To Be 16 A hepatitis C treatment is a 07 Editorial well-deserving winner of the Battle of the Sexes, 09 Bio-Responsive Insulin Delivery 2015 Drug Discovery of the by Stephanie Sutton Year Award, says Ann Hayes 10 Harnessing Adeno-Associated Vectors 17 Johan Bengtsson-Palme and D.G. Joakim Larsson believe it’s 11 Parting Shot time for companies to live up to On The Cover their ethical responsibilities 12 As Clear as Crystallization Celebrating the Power List 18 Will aerosol-based detectors with artwork inspired by the 13 Affliction Prediction ever meet all the needs of the Revolver album cover pharma industry? asks (the Beatles). 14 Moving from Batch to Continuous Dorina Kotoni ISSUE 18 - APRIL 2016 Editor - Stephanie Sutton [email protected] Associate Editor - James Strachan [email protected] Editorial Director - Fedra Pavlou [email protected] Content Director - Rich Whitworth [email protected] Publisher - Richard Hodson [email protected] Sales Manager - Helen Conyngham [email protected] Senior Designer - Marc Bird [email protected] Designer - Emily Strefford-Johnson [email protected] 50 Digital Content Manager - David Roberts [email protected] Mac Operator Web/Print - Peter Bartley [email protected] Tablet Producer - Abygail Bradley [email protected] 42 Best Practice Audience Insight Manager - Tracey Nicholls [email protected] 42 Beyond Keeping Traffic and Audience Associate - Lindsey Vickers Up Appearances [email protected] 10 Is film coating strictly necessary Traffic and Audience Associate - Jody Fryett for all tablets? There are many [email protected] reasons to decide against Apprentice, Social Media / Analytics - Ben Holah [email protected] coating, but there are also Events and Office Administrator - many benefits that go beyond Alice Daniels-Wright optimizing drug release. [email protected] Financial Controller - Phil Dale [email protected] Chief Executive Officer - Andy Davies [email protected] Business Chief Operating Officer - Tracey Peers [email protected] 48 Making Small Biotech Work The industry is increasingly Change of address: Features reliant on small biotechs [email protected] Tracey Nicholls, The Medicine Maker, for innovation, but drug Texere Publishing Ltd, Haig House, Haig Road, 21 The Power List development is expensive Knutsford, Cheshire, WA16 8DX, UK The Power List is back! It’s for anyone, let alone a small General enquiries: www.texerepublishing.com time to celebrate the Top 100 company. A sound strategy [email protected] +44 (0) 1565 745200 inspirational professionals can go a long way in helping to [email protected] involved in drug development secure success. and manufacturing, as Distribution: nominated by readers. The Medicine Maker (ISSN 2055-8201), is published monthly by Texere Publishing Ltd and is distributed in the USA by UKP Worldwide, 1637 Stelton Road B2, Sitting Down With Piscataway, NJ 08854. Periodicals Postage Paid at Piscataway, NJ and additional mailing offices Reports 50 Christian Schneider, Director POSTMASTER: Send US address changes to The Medicine Maker, Texere Publishing Ltd, C/o of the National Institute for 1637 Stelton Road B2, Piscataway NJ 08854 38 The Medicine Maker × Catalent Biological Standards and Single copy sales £15 (plus postage, cost available on request [email protected]) More Trial, Less Error Control (NIBSC), UK. Annual subscription for non-qualified recipients £110 Accelerate your bioprocess journey Speed and efficiency are crucial aspects of biomanufacturing. The right supplier can contribute to your success. Discover how our pioneering technologies, agile services, and ability to design and construct complete facilities improves speed to market. Engage with GE to access industry expertise and insights to accelerate your bioprocess journey. gelifesciences.com/bioprocess GE and GE monogram are trademarks of General Electric Company. © 2016 General Electric Company. First published Apr. 2016 GE Healthcare Bio-Sciences AB, Björkgatan 30, 751 843 Uppsala, Sweden 29204212 AA 04/2016 A Battle of the Sexes Editorial The Power List is back, but is it a fair representation of the male to female ratio in our industry? pring (and controversy) is in the air at The Medicine Maker. As well as celebrating longer (and hopefully sunnier) days, we are also celebrating influential professionals in the world of drug development and manufacture. April is the season of The Power List! SWe’ve been busying ourselves with the 2016 Power List since the inaugural list last year. What is the process? First, we ask you, our readers, to submit nominations and then seek the advice of an expert (but anonymous) judging panel, who whittle the names down to 100 – and rank the Top 20. Not all of you will agree with the list, but at the very least, we hope that it promotes both celebration and discussion. Some of you may be aware that The Medicine Maker has four sister publications across science and medicine, each publishing its own annual Power List. And although the names and faces are clearly different, a common trend runs across all the lists: both the nominees and the final list are heavily dominated by men. In fact, women make up just 18 percent of The Medicine Maker’s 2016 Power List (but