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Pharmaceutical Manufacturing and Packing Sourcer |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of PMPS |
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| In her Editor's Letter, Dr Patricia Lobo offers a round up of pharma manufacturing from a media perspective |
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| Ashley McCraight and Dr Steve Moss from the Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance, ask How Should Pharmaceutical Excipient Manufacture be Controlled? and offer PS 9100:2002 as the answer |
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| In Contract Manufacturing of Biopharmaceuticals: The Regulatory Framework, Dr Trevor Marks, Manufacturing Business Manager at the Centre for Applied Microbiology and Research (CAMR), explains why the choice of contract manufacturer is critical for small companies seeking to bring product to market |
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| The expectations of biotechnology products are growing as they enter late stage clinical phases. Liselotte Larsson PhD, Marketing and Sales at Novozymes Biopharma AB, outlines the importance of Current Good Manufacturing Practice for Biological APIs |
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| George Smith, Head of Process Technology and Validation, at Manesty, considers how to reduce the time taken to achieve regulatory compliance, in Validation - The Evolution |
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| Successful dietary supplementation of live probiotic bacteria must function within a set of parameters similar to those faced by orally administered pharmaceuticals. Michael Hite, Stephen Turner and Cathy Federici of SCOLR® Inc, explore Probiotics: Manufacturing and Packaging Considerations and Recent Developments in Oral Delivery |
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| Paul Norton, William F O'Dell, and Graham Reynolds at West Pharmaceutical Services Inc, debate Advancing Reconstitution of lyophilised drugs, when liquid bioengineered medicines are unstable |
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| In Controlled Delivery Technology in Nutraceutical Applications: A User's Perspective, Dr Michelle Jones, Technical Manager Europe at ADM Natural Health and Nutrition, in association with SCOLR® Inc, reviews the science behind CDT and its benefits |
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| The problem of counterfeiting is growing rapidly. A new category of intelligent security technologies is being developed to combat this problem. Joe Pleshek, Brand Protection Market Manager at Appleton Security Products, looks at solutions, in Assuring Authenticity... An Issue of Global Importance |
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| Jan Van Laethem, Product Manager of Security Systems at dotrix NV, explores the industrial inkjet approach as a cost-effective solution for anticounterfeiting, in Inkjet Digital Printing Offers Additional Solutions in the Battle Against Anticounterfeiting |
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| In Drug Counterfeiting Epidemic Spurs Urgent Need For Co-Operation, Jonathan Senft of Reconnaissance International, reviews the recent Geneva summit which called for concerted action from packagers, manufacturers and governments |
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| When it comes to brand protection time and money can be saved by adding anticounterfeit security to packages. Peyton Old of ITW Holopak asks, Counterfeit Protection: Overt or Covert Security? |
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| In Stability Issues and Outsourcing Solutions, Elma Brennan, Head of the Pharmaceutical Laboratory at RSSL Pharma, warns us not to underestimate resource stability trials - a vital element in the drug registration process |
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| In recent years claims that non-reclosable flexible blister packaging for pharmaceutical solid dose products are not child safe have become more frequent. In Child-Resistant Blister Packs, Tassilo Korab, Director, Head of the Business Unit Pharma Packaging at Teich, brings us up-to-date on crucial new standards |
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| David Scotting, Sales Director at FDL Packaging Group, guides us through greener, cost-effective packaging alternatives, in Industrial Packaging Solutions - The Environmentally-Friendly Approach |
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| In Cartridges - Pharmaceutical Use and Processing, Dr Jörn Möckel, Head of Production and Development at Weimer Pharma GmbH, takes us through the pros and cons of cartridge-based dosing |
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| Dana Kaplan, Vice President of Marketing and Business Development at Inksure Inc, provides an insight into initiating a product security programme, in Maximising the Benefits of Brand Security - New Developments for Smart Protection |
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| Pharmaceutical manufacturers have a major problem - once a box of tablets has been closed or a bottle of pills sealed, they have no way of knowing exactly what is inside. Rob Karsten, Sales and Marketing Director at Flying Null, uncovers new tagging technologies to combat counterfeiters, in What's in the Box? |
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| In Particle Monitoring and Control, Tim Sandle, Microbiology Manager at Bio Products Laboratory, examines some approaches to the monitoring of particles |
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| Peter Koger, European Product Manager at the PMT Partikel-Messtechnik/A&LCO industries group, discusses the threat spores pose, in Spores and Sporocides - The Ultimate Cleanroom Challenge |
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| Dramatic developments surround the standardisation of cleanroom cleanliness and air filtration. Gordon Farquharson, Chartered Engineer and Principal Consultant, Pharmaceutical Division of Bovis Lend Lease, explores suitable procedures, in GMP Compliance in Cleanroom Environments |
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| In Changing to Washing-in-Place - A Major Step Towards the Future? Ines Andersen, Pharmaceuticals Product Manager at Wilhelm Fette GmbH, reveals the benefits of this technology |
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| Robin Davies, Managing Director of Isopak, discusses handling medication in liquid form, in Liquid Capsules are the Future |
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| The hard gelatine capsule has proved to be a versatile dosage form. In The Small Scale Production of Hard Gelatine Capsules, Fred Higton, Head of Formulation Development at Penn Pharmaceutical Services Limited, explains why it is his method of choice for clinical trials |
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| In Life Cycle Management - Developing New Dosage Forms for New Indications, Erwin Douwes, Marketing Director of Banner Pharmacaps Europe, looks at the risks involved and offers a solution |
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| Emmanuel Dimotakis and Robert A Nash, Department of Chemical and Pharmaceutical Engineering at the New Jersey Institute of Technology, provide part II of their review of matrix and coating systems, in Modified-Release Oral Solid Dosage Forms - Part II: Microstructure and Release Mechanisms |
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| 'Convenience dosing' (taking medication without water) has become increasingly popular. Robert E Sparks, Director of R&D, and Irwin C Jacobs, Director of Chemical Technology, at Particle and Coating Technologies Inc, discuss the importance of Taste-Masking of Particles in Oral Dosage Forms to accommodate this new trend |
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| Dr Patricia Lobo, Editor of PMPS, met Heinz Stamm, General Manager of Fisher Clinical Services, to talk about the distribution infrastructure, in Automated Logistics for Global Distribution of Clinical Trial Supplies |
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In Taking the Tribulations Out of the Trials - An Examination of the Role of the Validated Cold Chain Shipper in Clinical Trials, Tim Jennings, Sales Manager at Laminar Medica Ltd, investigates ways to avoid delay in product-to-market times
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| Temperature controlled shipping containers are a leading method of moving large volumes of sensitive products from continent to continent. Mike Sanderson Walker, Director of Cargo Quality Ltd, reflects on The Care of Pharmaceuticals Carried by Sea in Temperature Controlled Containers |
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| PMPS talk to Joseph Saccomanno MS, RPh, Director, Study Planning & Design at BlisTech Corporation, about Knowledge Sharing in the Clinical Trials Industry |
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| In The Trouble with Blister Packing for Clinical Trials..., Ernest Parker, Founder of SEPHA Ltd, takes us through quality and stability issues associated with clinical trials |
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| In Generic Medicine - What's in it for the Health Service?, Dr Luis Filipe Pereira, Portugal's Minister for Health, talks to Dr Patricia Lobo, Editor of PMPS, about his Government's role in the generic medicines market |
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| Michael Gamlen, Managing Director of Pharmaceutical Development Services Ltd, suggests reasons why Good Development Manufacturing Contributes to Drug Development Success |
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| While pharma faces its toughest challenge yet from generics competition, Bluepharma's newly opened R&D services laboratories will boost the flow of new products. Dr Patricia Lobo, Editor of PMPS investigates, in Discovery and Product Development |
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News and Press Releases |
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Cidara Therapeutics Doses First Patient in Pivotal Phase 3 ReSPECT Trial of Rezafungin for Prevention of Invasive Fungal Disease in Patients Undergoing Allogeneic Blood and Marrow Transplantation
SAN DIEGO, Calif. & CAMBRIDGE, England, May 20, 2020 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company’s lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.
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White Papers |
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Syringe siliconization
Gerresheimer AG
Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
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Industry Events |
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World Vaccine Congress Europe
18-21 October 2020, Barcelona, Spain
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >> |
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