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PharmTech Europe

24 May 2016

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Top Stories

Pfizer to Acquire Anacor

Pfizer will acquire Anacor for $5.2 billion and expects the transaction to complete in the third-quarter of 2016.
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EMA Publishes Annual Report

The agency detailed its 2015 achievements in an annual report.
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Industry News

NIH to Launch Large-Scale HIV Vaccine Trial

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen.
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ISSCR Releases Updated Guidelines on Stem Cell Research

The updated guidelines detail best practices for conducting research with human embryonic stem cells.
/ read more /


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EXPERT INTERVIEW

Douglas B. Hausner, PhD, from the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University, discusses rapid process development for solid-dosage drugs using continuous
manufacturing.

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Regulatory News

What's Behind NIH's Quality Problems?

Drug manufacturing lapses undermine NIH research programs.
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FDA Issues Biomarker Qualification Guidance

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
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Bio/Pharma News

AXIM Begins Clinical Trials with CBG Ointment

The Phase I trials will examine AX-1602's clinical efficacy for the treatment of psoriasis and eczema.
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Caribou Biosciences Completes Series B Financing Round

Caribou announced the completion of a $30-million Series B financing round, which included the participation of new and current investors.
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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping

On Demand
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Supplier News

Jones Packaging and TUKU Develop Web-Enabled Packaging Platform

The companies entered into a commercial collaboration to develop web-enabled packaging for pharmaceutical and consumer goods companies.
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Althea Patents Method to Crystallize Proteins

The company's method reduces the time required to crystallize antibodies from weeks to one day.
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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
On Demand
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FEATURED TOPICS

STANDARDS & REGULATIONS

EU on a Mission to Boost R&D

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.
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SCALE-UP

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.
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FORMULATION

A QbD Method Development Approach for a Generic pMDI

Application for sirdupla uniformity of delivered dose methodology.
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API SYNTHESIS & MANUFACTURING

Upstream and Downstream Operations Can Impact Biologic API Uniformity

Bioprocess operations—from cell line selection to final filtration—can influence the consistency and purity of biologic drug substances.
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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
On Demand
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Product/Service Profile

Shimadzu

Nexera XR
Tried and trusted all-rounder

A true multi-talent, the Nexera XR ultra high performance liquid chromatograph has become an indispensable tool in laboratories of versatile industries, such as pharmaceuticals, biochemistry, chemistry, environmental and foods. Users benefit from high-speed, high-resolution analysis without compromising robustness or reliability.
/ 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


Stability Assessment for Shipment of API and Drug Products

On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by Patheon


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Events

Chemspec Europe 2016

1-2 June, 2016 | Basel, Switzerland

BioPharm America 2016

13-16 September, 2016

AAPS Annual Meeting and Exposition

13-17 November, 2016 | Denver, Colorado


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REFERENCE LIBRARY

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

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

2016 Solid Dosage Drug Development and Manufacturing eBook

New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
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