January 2017
Volume 40, No. 1 |
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| COVER STORY |
Rita C. Peters
Healthcare policies, R&D investments, and drug approvals will test bio/pharma.
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Rita C. Peters
Estimates that global medicine spending will reach nearly $1.5 trillion by 2021 and the types of therapies and use of innovator versus generic drugs, will vary by region.
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| PEER-REVIEWED RESEARCH |
Niels Væver Hartvig, Liselotte Kamper
The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
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PharmTech January Issue
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| GLOBAL PHARMA MARKET: THE YEAR AHEAD |
Jim Miller
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
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Jill Wechsler
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
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| QUALITY AND REGULATIONS |
Christian Fortunel
A four-stage process to successfully make the switch from paper to electronic batch records is presented.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.
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| SINGLE-USE MANUFACTURING |
Carole Langlois, Marc Hogreve, Jean Marc Cappia
The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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| PROCESS OPERATIONS |
Agnes Shanley
As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
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| FORMULATION: OLIGONUCLEOTIDES |
Ashleigh Wake
Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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| MANUFACTURING |
Johan Remmelgas
Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.
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| ANALYTICS: PROTEIN CHARACTERIZATION |
Natalia Markova
Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.
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| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.
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| PACKAGING FORUM |
Hallie Forcinio
Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.
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| FROM THE EDITOR |
Rita C. Peters
Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.
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| PRODUCT SPOTLIGHT |
The DualFUSION vials from Wheaton for the storage of lyophilized materials are engineered using a plasma enhanced chemical vapor deposition technology to fuse an organosilicate protective layer with silica-like barrier layer, and then fuses that inner material to a cyclic olefin polymer outer shell.
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The Ross SysCon control panels can now be supplied with a fully automatic Type X Purge System, which forces clean air through the enclosure until all hazardous gases are removed.
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The Thermo Scientific Decapper 500 and 550 series tube capping systems are fully automated capping systems for use in medium- to high-throughput biotech, pharmaceutical, and clinical laboratories doing compound storage, high-throughput screening, biobanking, and genomic storage.
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The new patent-pending PolarDry Electrostatic Spray Dryer from Fluid Air, a division of Spraying Systems Co., uses electrostatic technology, rather than heated drying gas, for microencapsulation.
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| Events |
February 1–2, 2017
March 13–15, 2017
May 16–18, 2017
more events
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