Top Stories
The White House nominates Robert Califf to head FDA, but will he be confirmed?
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According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.
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SHARE YOUR KNOWLEDGE
PharmTech seeks objective, technical articles and papers from the bio/pharma community. Learn how you can contribute.
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Industry News
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
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PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.
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Supplier News |
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Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company's San Diego facility.
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SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.
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Bio/Pharma News
Aragen Bioscience has licensed ProteoNic Biotechnology's 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.
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Regulatory News
FDA publishes the final Q3D Elemental Impurities guidance.
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Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.
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FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.
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FEATURED TOPICS |
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QUALITY
QbD is improving the safety of solid-dosage drug products as well as improving manufacturing processes, despite some industry reluctance.
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| FACILITIES
Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.
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| ANALYTICS
To enable efficient monitoring systems, life-science companies need to effectively apply run rules.
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Training Course - October 15-17 - Basics of Tablet Manufacturing and Troubleshooting;
Learn the basics of tablet shapes and design, tablet press setup & operation, tooling options and steel types, tool inspection, and tool reworking and polishing – with hands-on experience.
This course is designed for tablet compression industry professionals, including tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and supervisors.  Read more |
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NEW PRODUCTS AND SERVICES
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AbbVie Contract Manufacturing business has been serving our partners for more than 35 years.
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EtQ is a leading FDA Compliance, Quality, EHS, and Operational Risk Management software provider.
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Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids.
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VAI introduces a new line of Cleanroom Documentation.
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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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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 |
On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.
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Establishing a Risk Management Plan for Compliance and Pharmacovigilance
LIVE WEBCAST: Wednesday, September 23, 2015 at 11:00 am ET
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on pharmtech tv
Trends and Concerns in Capsule Production
Application of External Lubrication in Tablet Production
FDA Comments on Continuous Manufacturing
Building Biopharmaceutical Manufacturing Processes
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Events
September 28–30, 2015 | Washington, DC, USA
September 28–30, 2015 | Las Vegas, NV, USA
October 25–29, 2015 | Orlando, FL, USA
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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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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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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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