Pharmaceutical Technology ePT Weekly
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PharmTech
April 19, 2018
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In this issue:

New Jersey Firm Gets FDA Warning Letter

Making the Move to Electronic Batch Records

Report Gives Update on International API Inspections


Top Stories

Alexion to Acquire Wilson Therapeutics for $855 Million

According to Alexion, the acquisition will help rebuild its clinical pipeline.
/ read more /


Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.
/ read more /


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Industry News

Report Gives Update on International API Inspections

A new report gives an overview of the work of the International API Inspection Program.
/ read more /


Premier Pharmacy Labs Recalls Products Due to Sterility Concerns

The company is voluntarily recalling multiple products because of the potential lack of sterility assurance.
/ read more /


More Industry News

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Supplier News

Sartorius, Penn State Announce Partnership

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university's Center of Excellence in Industrial Biotechnology.
/ read more /


Arcinova and the University of Nottingham Announce Grant for Continuous Processing Technology

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.
/ read more /


More Supplier News
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Bio/Pharma News

Amgen to Build Next-Generation Biomanufacturing Plant

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant.
/ read more /


Pfizer Relocates Global Headquarters

The New York City-based company will relocate to another building in the city.
/ read more /


More Bio/Pharma News

Regulatory News

New Jersey Firm Gets FDA Warning Letter

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
/ read more /


EMA Relocates Drug Evaluations to EU Member States

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
/ read more /


More Regulatory News

FEATURED TOPICS

ANALYTICS

Certificates of Analysis: Don't Trust, Verify

Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
/ read more /

EQUIPMENT

New and Updated Equipment Streamline Manufacturing Operations

Equipment and product innovations improve pharmaceutical manufacturing tasks.
/ read more /

VACCINES

Modern Manufacturing Key to More Effective Vaccines

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
/ read more /

STANDARDS & REGULATIONS

Making the Move to Electronic Batch Records

Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
/ read more /


UPCOMING WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
Live Webcast: Wednesday, April 25 at 10:00am EDT
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now

ON DEMAND WEBCASTS

Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
On Demand
Learn more


Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
On Demand
Learn more

Events

CPhI North America

April 24–26, 2018

Pharmacopoeia Conference

May 29–30, 2018

BIO International Convention

June 4–7, 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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