Top Stories
Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.
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The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
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Industry News
Although the presidential candidate seeks to cap monthly drug costs to $250 for covered drugs, what will happen to drug costs that are associated with co-insurance?
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US Compounding, Inc. issues voluntary recall of all sterile products.
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Supplier News
Pharma development and manufacturing firm Patheon announces new tagline and logo.
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Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.
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Bio/Pharma News
Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.
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MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.
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Regulatory News
The agency releases guidance on controlled correspondences related to generic-drug development.
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FEATURED TOPICS |
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QUALITY
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting; available information shows that exposure to low-level elemental impurities is unlikely to be a substantive concern for topical drug products.
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VALIDATION
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
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FORMULATION
Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel's Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.
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BIOLOGICS
The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.
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Tablet quality issues? You need this digital handheld microscope on special for a limited time at
 natoli.com/specials. You’ll find inspection equipment and more in the new edition of Natoli’s Tablet Compression Accessories Catalog – available for download along with Tablet Press Replacement Parts Catalogs on Natoli’s website. |
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Webcasts
Wednesday, Oct. 7 2015 | 2–3 pm EDT
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience |
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Advance the LC Characterization of Bio-therapeutics – Agilent eSeminar Series.
Presented by industry experts we cover UHPLC techniques for advanced characterization of therapeutic biomolecules using state-of-the art technologies:
• Improved Speed and Accuracy of mAb Primary Structure Characterization
• Does N-Glycan Need to be Complicated?
• Size Exclusion Chromatography Strategies for the Characterization of Protein Biopharmaceuticals
• Accurate and Reliable Characterization of Impurities in Oligonucleotide Therapeutics
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On Demand
Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.
Sponsored by BASF
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Technology Transfer from a CDMO Perspective
The global pharmaceutical industry continues to outsource its drug manufacturing needs, an ongoing trend that shows no sign of abating and which poses critical technical and business challenges. One of those challenges continues to be tech transfer.
Joe Cobb, CPIP, director of pharmaceutical development at Metrics Contract Services, recently shared industry challenges from the contract manufacturing side of the industry.
 Learn more and view Cobb's presentation at metricsinc.com. |
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on pharmtech tv
Blow-Fill-Seal for Aseptic Processes
Biologics Development and Manufacturing Trends
Building Biopharmaceutical Manufacturing Processes
The Transition from Paper Records to Electronic Batch Records
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Events
October 25–29, 2015 | Orlando, FL, USA
October 27–29, 2015 | Philadelphia, PA
December 08–10, 2015 | Philadelphia, PA
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Establishing a Risk Management Plan for Compliance and Pharmacovigilance
On Deamand
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REFERENCE BOOKS |
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This three-volume set of comprehensive pharmacology reference guides cover solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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