Pharmaceutical Technology ePT Weekly
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PharmTech
May 28, 2015
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

Fixing Tableting Problems
Visterra Partners to Develop a mAb
FDA Approves COPD Treatment

Top Stories

House Committee Approves 21st Century Cures Legislation

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015. / read more /


Generic Opioids Create Policy Issues

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations.
/ read more /


MIT Scientist to Present at BIO 2015

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.
/ read more /


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Supplier News

CMC Biologics Expands Denmark Facility

The Denmark facility will incorporate CMC's Bioreactor 6Pack configuration in one manufacturing line. / read more /


Waters Announces New Mass Spectrometry Technology

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.
/ read more /

More Supplier News

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Bio/Pharma News

Visterra Partners to Develop a mAb

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever. / read more /


Merus and Selexis Receive Grant for Bispecific Antibody Therapeutics

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy. / read more /

More Bio/Pharma News

Regulatory News

Boehringer Gains FDA Approval of COPD Treatment

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD. / read more /


Physician Groups Band Together on Labeling of Biosimilars

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
/ read more /

More Regulatory News
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The largest, most influential biotech meeting in the world is coming to Philadelphia, June 15-18, 2015, offering powerful business partnering, invaluable education sessions and networking with the industry’s best and brightest. Join the global biotech community at BIO 2015 and fuel the extraordinary.
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FEATURED TOPICS

REGULATORY WATCH

FDA Revises Field Inspections to Reflect Global Market and Quality Initiatives

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities. / read more /

MANUFACTURING

Fixing Tableting Problems

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems. / read more /

SUPPLY CHAIN

Planning for the Future of Serialization

Compliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry. / read more /

VALIDATION AND COMPLIANCE

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

Silver's antimicrobial effects have been recognized since ancient times. / read more /

PROCESS CONTROL

Electronic Batch Records Offer Advantages beyond Automation

Transitioning from paper records to electronic batch records decreases costs and increases efficiency. / read more /

OUTSOURCING

More Evidence that Size Matters

Big service providers get bigger faster thanks to Big Pharma. / read more /

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Controlling the Physical Properties and Performance of Semi-solid Formulations through Excipient Selection
Live Webinar: Wednesday, June 10, 2015 at 11am EST
Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Register for free


Webcasts

Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

Wednesday, June 17, 2015, 2 pm EDT | 2 pm EDT | 11 am PDT

Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC

Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications

On Demand

Particle engineering via spray drying, in combination with specialized capsule technology, is ideally suited for the rapid development of inhaled formulations for early clinical trials. Learn about a pulmonary platform technology for rapid-to-clinic applications in this educational webcast.
Sponsored by: Capsugel

more webcasts
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

Live Webcast: Thursday, June 4, 2015 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Register for free



on pharmtech tv

PharmTech TV

FDA Applications and New Guidance Documents

Compliance and Technology for Track and Trace

Solid-Dosage Continuous Manufacturing Processes

FDA Comments on Continuous Manufacturing

Events

ISPE/FDA/PQRI Quality Manufacturing Conference

June 01 –03, 2015 | Washington, DC USA

2015 AAPS National Biotechnology Conference

June 08 –10, 2015 | San Francisco, CA USA

BIO International Convention 2015

June 15 –18, 2015| Philadelphia, PA USA

more events
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Register Free


REFERENCE BOOKS

Process Analytical Technology Resource Guide Combo

A compilation of informative, useful articles from Pharmaceutical Technology designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.

More Reference Library

eBOOKS

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid – and semi – solid dosage forms.

more ebooks
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