Pharmaceutical Technology ePT Weekly
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PharmTech
June 25, 2015
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in this issue

Using mAbs to Access Undruggable Targets
Kite Collaborates with bluebird bio
Updates in Ph.Eur.

Top Stories

Cancer Drug Outcomes Comparative Tool

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results—and costs—of popular cancer medications.
/ read more /


Allergan Acquires Kythera for $2.1 Billion

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.
/ read more /

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Industry News

NIH Plan Addresses Deficiencies

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
/ read more /


Using mAbs to Access Undruggable Targets

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.
/ read more /


More Industry News

Supplier News

SGS to Open New QC Lab Near Paris

A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.
/ read more /


MFG Tray Recognizes Distributor

MFG Tray names ChemTech International as its first Master Pharmaceutical Distributor.
/ read more /


More Supplier News
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Ion exchange resins have long been in the formulator's toolkit, but only recently has there been an increased interest in their use as excipients. Dow AMBERLITE™ and DUOLITE™ ion exchange resins have a broad range of applications, including taste masking, tablet disintegration, modified release, and the formulation of poorly soluble or unstable drug compounds.
Read More



Bio/Pharma News

Kite Collaborates with bluebird bio to Develop T-Cell Therapy Products

Kite announces that it will collaborate with bluebird bio to develop and commercialize second-generation T-cell receptor product candidates for HPV-associated cancers.
/ read more /


Teva's Patent for Copaxone Invalidated

The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.
/ read more /


More Bio/Pharma News

Regulatory News

European Pharmacopoeia Commission Updates Ph.Eur.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
/ read more /


ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage

The International Conference on Harmonization finalizes Q&A document on APIs.
/ read more /


More Regulatory News
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Successful Binding of Peroxide Sensitive APIs
Live Webinar: Tuesday, July 7th 2015 at 10 am EDT
In this live webinar, Bernd and Jan will showcase how you can formulate your peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Register for free


FEATURED TOPICS

QUALITY

Ensuring the Quality of Biologicals

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
/ read more /

REGULATORY BEAT

EU's New Post-Authorization Variations Framework Comes Under Scrutiny

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.
/ read more /

MANUFACTURING

Pharma APIs: It's Still a Small World

Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs.
/ read more /

TROUBLESHOOTING

Designing Trouble-Free Freeze-Drying Processes

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
/ read more /

PEER–REVIEWED

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

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.
/ read more /

OUTSOURCING

Another In-House Operation Gets Outsourced

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
/ read more /

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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

On Demand
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.
Learn more


Webcasts

The Importance of Data Integrity in a GXP Regulated Laboratory

On Demand

With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo


Applying Water Activity to Pharmaceutical Technology

On Demand
Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.

Sponsored by: Decagon Devices


more webcasts

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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.
Learn more



on pharmtech tv

PharmTech TV

External Lubrication in Tablet Production

Trends and Concerns in Capsule Production

Focus on Biobetters, Part 2

Feeding Powders in Pharmaceutical Processes

Events

DCAT Sharp Sourcing 2015

July 16, 2015 | New Brunswick, NJ

29th Annual Symposium of The Protein Society

July 22–25, 2015 | Barcelona, Spain

10th Annual Manufacturing Execution System (MES)

August 12–13, 2015 | Philadelphia, PA


more events

REFERENCE BOOKS

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. / Learn more /


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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