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Pharm Tech
March 2015
Volume 27, No. 3
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Focus

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Andrew Teasdale, Cyrille C. Chéry, Graham Cook, John Glennon, Carlos W. Lee, Laurence Harris, Nancy Lewen, Samuel Powell, Helmut Rockstroh, Laura Rutter, Lance Smallshaw, Sarah Thompson, Vicki Woodward, and Katherine Ulman

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
/ read more /

PharmTech Europe March Issue
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Featured content

Lyophilization Cycle Optimization of Cell-Derived Products

Randi Hernandez

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. / read more /


FORMULATION

Semi-Solid Dosage Forms

Adeline Siew, PhD

While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge. / read more /


Peer-reviewed research

Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging

P.J. Cullen

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. / read more /


API SYNTHESIS & MANUFACTURING

Minimizing Risk during HPAPI Manufacture

Cynthia Challener, PhD

Protecting workers, patients, and the environment requires advanced technologies. / read more /


TROUBLESHOOTING

Removing Aggregates in Monoclonal Antibody Purification

William Evans

Several chromatographic resins are available for downstream purification. / read more /


REGULATORY WATCH

Europe Strives for a More Efficient Generic-Drug Approval Framework

Sean Milmo

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference. / read more /


OTHER FEATURES

Managing Supplier Data Collection

Siegfried Schmitt

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.
/ read more /


Webcasts

Lyophilization Cycle Design and Scale Up- Practical Methodologies for Developing Cycles

(On Demand)
Learn how to optimize Lyo Cycle Design and establish robust scale-up methodologies.
Sponsored by: Patheon

Practical Implications of the Lifecycle Approach to API Process Validation

(On Demand)
API process validation experts describe the different activities required during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. Hear about key requirements for API process validation including regulatory requirements, manufacturing conditions, data collection, testing to be performed, sampling plans, and analytical method validation.
Sponsored by: Regis Technologies Inc.

more webcasts

on pharm tech tv

Challenges in Maintaining the Cold Chain

Prefilled Syringes for Clinical Trial Use

Child-Resistant, Senior-Friendly Packaging

Cross-Contamination Risk in Manufacturing of Highly Potent Drugs

Events

INTERPHEX 2015

April 21-23, 2015 | New York

13th EGA-European Biosimilars Group Conference

April 23-24, 2015 | London, England

RDD Europe 2015

May 05-08, 2015 | Antibes, France

more events
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