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PharmTech Europe

9 August 2016

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Top Stories

EMA Publishes Report on Adaptive Pathways Pilot Project

The report addressed how the agency might support medicine development for patients' unmet medical needs.
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Plasticell and National University of Ireland Form Stem-Cell Pact

The collaboration will focus on methods to eradicate cancer stem cells.
/ read more /


NIH Launches Zika Vaccine Clinical Trial

The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.
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EXPERT INTERVIEW

Richard Denk, head sales containment at SKAN, spoke with Pharmaceutical Technology about trends in handling high potency APIs.

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Industry News

FDA Releases First Doses of Sanofi Pasteur Influenza Vaccine for Shipment

Sanofi Pasteur will deliver the first of more than 65 million influenza vaccines to the United States throughout the 2016–2017 flu season.
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NIST Issues mAb Reference Standard

NIST's monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
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Regulatory News

EMA Launches Public Consultation on Guidance for New Tuberculosis Treatments

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.
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The Industry Hopes Congress Approves PDUFA Program in 2016

FDA and industry seek speedy Congressional approval of new user fee plan.
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More Regulatory News

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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
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Bio/Pharma News

Amgen: Neulasta Safe for Now; Dose Accuracy of Erenumab a New Focus

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.
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Pfizer Shores Up Cell Therapy with Acquisition of Bamboo Therapeutics

The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.
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Supplier News

Velesco Pharma Opens New Materials Handling Laboratory at Its Plymouth, Michigan Site

The new materials handling laboratory will be used for storage, dispensing, inventory management, and distribution of non-GMP materials.
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Piramal to Expand Sterile Manufacturing in Kentucky

The company will install new vial-filling and lyophilization capacity, including an isolator-based filling machine. The new filling equipment will result in a five-fold increase in the company's current filling capacity.
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FEATURED TOPICS

STANDARDS AND REGULATIONS

Pharmaceuticals in the Environment Spark Controversy

The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.
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OUTSOURCING

Bio/Pharma Funding Challenges Could Hurt CDMOs in 2017

CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D spending at risk in 2017.
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FORMULATION

The importance of lipid screening in the development of lipid-based formulations

Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.
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MANUFACTURING

Maximize Efficiency in Tooling Maintenance

A seven-step process may reduce many common tablet and tooling problems, resulting in a better quality end product.
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Product Profile

Thermo Scientific

Revitalize your pesticide quantitation workflows
The Thermo Scientific™ Pesticide Explorer Collection is a comprehensive set of LC-MS solutions designed for laboratories performing routine quantitation, targeted and non-targeted screening of pesticide residues in food matrices.
/ Read more/

EtQ

EtQ Reliance Solution for Life Sciences

EtQ is the leading Quality, Compliance and EHS Management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration.
/ Read more /

Event Profile

CPhI Worldwide, ICSE, InnoPack, P-MEC, FDF

Date: Exhibition: 4th-6th October, 2016 Pre-Connect Congress : 3rd October 2016
Venue: Fira de Barcelona Gran Via, Barcelona, Spain
CPhI Worldwide, the world's leading pharmaceutical platform, co-located together with ICSE, InnoPack, P-MEC and FDF, brings together year on year over 36,000 industry experts from 153 countries around the world to meet and greet, do business and shape the future of the global pharmaceutical industry.
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Webcasts

Compliance is Key: Solutions to Decrease the Likelihood of Receiving a Form 483

On Demand

What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance. Every company that produces pharmaceutical products must guarantee a consistent quality product that meets regulated specifications for the entire product life cycle, from production to consumption. What happens when that compliance falls short? A review of inspection citations from 2015 can help you learn from the mistakes of others. Learn about solutions to decrease the likelihood of receiving an FDA Form 483.
Sponsored by Anton Paar


Effective Extractables and Leachables Evaluation Programs for Single-Use Systems

On Demand
As single-use systems gain wider use in biopharmaceutical manufacturing, drug owners must understand the risk of potential contaminants from plastics interacting with the drug. Establishing clearly defined standards for acceptable testing protocols and has proven difficult. In this webcast learn about available guidance documents, a risk-based materials qualification process for extractables and leachables studies; and the value of standardized and custom testing protocols.
Sponsored by SGS


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Events

14th Annual Pharmaceutical IT Congress

28-29 September, 2016 | London, England

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany


more events
 

Reference Library

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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More Reference Book

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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