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Pharmaceutical Technology-03-02-2015
Pharmaceutical Technology
Vaccine Development and Production Challenges Manufacturers
March 02, 2015
Regulatory Watch
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Scientists and industry experts seek effective preventive therapies to combat global disease.
Europe Strives for a More Efficient Generic-Drug Approval Framework
March 02, 2015
Regulatory Watch
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Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.
Kason Offers Screen Replacement
March 02, 2015
Product Spotlight
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Kason’s K-Series screen replacement program for round vibratory screeners decreases downtime and cost and offers screens designed for any make or model of screener.
GEA Homogenizer Offers Scalability
March 02, 2015
Product Spotlight
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GEA Niro Soavi’s PandaPLUS 2000 is a tabletop laboratory homogenizer that is designed for the treatment of nanoparticles, nanodispersions, nanoemulsions, and cell disruption.
PolyScience Chiller and Circulator Enhances Temperature Control
March 02, 2015
Product Spotlight
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PolyScience’s recirculating chillers and refrigerated circulators control temperature with stabilities as precise as ±0.005 °C for analytical instrumentation.
Ross Control System Increases Consistency
March 02, 2015
Product Spotlight
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Ross’ SysCon PLC-based Control Systems are designed for sequential control of automated processes including mixing, pumping, chemical dosing, water treatment, fractionation, and heat exchange.
Industry Expert Q&A with Richard Grant
March 02, 2015
Industry Leaders
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Richard Grant, Global VP of Cell Therapy at Invetech discusses the advantages and challenges of developing and manufacturing personalized immunotherapies.
Managing Supplier Data Collection
March 02, 2015
Ask the Expert
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Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.
The Global Biomanufacturing Outsourcing Market
March 02, 2015
Global Market Report
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The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
Lyophilization Cycle Optimization of Cell-Derived Products
March 02, 2015
Cover Story
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While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.
Minimizing Risk during HPAPI Manufacture
March 02, 2015
API Synthesis and Manufacturing
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Protecting workers, patients, and the environment requires advanced technologies.
Tools of the Trade for Preventing Drug Shortages
March 02, 2015
Insider Solutions
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A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
Agenda: INTERPHEX 2015
March 02, 2015
From The Editor
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Sessions address cell therapies, tableting, continuous processes, serialization, and more.
Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities
March 02, 2015
Special Report
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Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Semi-Solid Dosage Forms
March 02, 2015
Formulation
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While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.
Considering GMPs In Room Design
March 02, 2015
GMP Facility Design
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Cleanability is crucial when choosing components for GMP manufacturing areas.
Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging
March 02, 2015
Peer-Reviewed Research
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The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
Removing Aggregates in Monoclonal Antibody Purification
March 02, 2015
Troubleshooting
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Several chromatographic resins are available for downstream purification.
CMOs Plan for Capacity Expansions
March 02, 2015
Outsourcing Outlook
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Is there enough talent to go around?
USP Publishes Monoclonal Antibody Guidelines
March 02, 2015
Inside USP
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A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
Pharmaceutical Technology, March 2015 Issue (PDF)
March 02, 2015
Issue PDF
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Click the title above to open the Pharmaceutical Technology March 2015 issue in an interactive PDF format.