Pharmaceutical Technology ePT Weekly
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PharmTech
February 01, 2018
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In this issue:

Meeting Data Integrity Requirements

Metrohm USA Opens New Headquarters

CDER Announces Guidance Documents

Top Stories

Sanofi to Acquire Ablynx in $4.8-Billion Deal

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.
/ read more /


EMA Wants to Know if Pharma is Ready for Brexit

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.
/ read more /

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Industry News

Pfizer Canada Announces EpiPen Shortage

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.
/ read more /


Univercells to Develop Antibody Production Platform with $2.9-Million Grant

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.
/ read more /


More Industry News
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2018 PDA Annual Meeting
The 2018 PDA Annual Meeting will deliver the same high-quality content attendees expect in a NEW meeting format that starts on Monday afternoon. Delve into the future of bio/pharmaceutical manufacturing with the latest updates on the end user/patient perspective, innovative manufacturing strategies, and disruptive technologies. The industry’s increased use of big data, artificial intelligence and robotics will also be explored.
Learn more and register today.


Supplier News

Metrohm USA Opens New Headquarters

The company relocated to Riverview, Florida.
/ read more /


AGC Biologics, Biomeva GmbH, CMC Biologics Combine

The companies will be integrated to form the newly-branded AGC Biologics, which will specialize in customized contract development and manufacturing organization services for the scale-up and cGMP manufacture of protein-based therapeutics.
/ read more /


More Supplier News
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2018 Pharma Quality Outlook: The New Role of Quality Teams
This report examines the results of a Pharmaceutical Technology survey on 2018 quality goals and obstacles. The report findings offer insight into how quality teams can impact company-wide performance in 2018. Download the White Paper


Bio/Pharma News

AbbVie Expands Oncology Capability at Ireland Site

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.
/ read more /


Celgene to Acquire Juno Therapeutics in $9-Billion Deal

The acquisition builds on the companies' earlier collaboration to develop T-cell-based therapeutics.
/ read more /


More Bio/Pharma News

Regulatory News

CDER Announces Guidance Documents

The FDA center released its list of planned guidance documents for the rest of 2018.
/ read more /


FDA and FTC Send Warnings Over Illegal Opioid Products

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
/ read more /


More Regulatory News

FEATURED TOPICS

QA/QC

Meeting Data Integrity Requirements

Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
/ read more /

Fill/Finish

In-Line Force Analysis During Vial Filling

Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.
/ read more /

Manufacturing

Pharma Equipment Gets Smart

The Industrial Internet of Things can be used to monitor equipment health, optimize processes, and enable modular facilities.
/ read more /

Supply Chain

Pharma Serialization Nears a Tipping Point

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.
/ read more /


UPCOMING WEBCAST

Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
Live Webcast: Thursday, February 15, at 1:00pm EST
Register now


Events

Pharmapack Europe

February 7–8, 2018

IFPAC-2018

February 11–14, 2018

ISPE 2018 Facilities of the Future Conference

February 20–22, 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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