PharmTech Europe, Weekly Alert
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PharmTech Europe
19 December 2017

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Top Stories

EMA Approves mAb Production at Samsung BioLogics Facility

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
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Outsourcing: A Year in Review

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
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Industry News

Ingredients for Bio/Pharma Career Advancement

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.
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Honeywell Survey Shows Low Adoption of Industrial Cyber Security Measures

A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.
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Regulatory News

Contract Manufacturing Raises Regulatory Concerns

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
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FDA Warns Companies for Promoting Street Drug Substitutes

The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.
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Bio/Pharma News

Novo Nordisk Expands Insulin Manufacturing Facility in India

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
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Gilead Sciences and Kite to Acquire Cell Design Labs

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.
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Supplier News

Phillips-Medisize Invests in Manufacturing Center of Excellence for Connected Health and Drug-Delivery Devices

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.
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WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.
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FEATURED TOPICS

FORMULATION

Manufacturing Microparticles in a Single Step

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.
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APIs & EXCIPIENTS

Hazardous Chemistry: Choosing Batch or Flow

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.
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FACILITIES

Designing Sustainable Pharma Facilities

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.
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SUPPLY CHAIN

Reliability Rooms and the Move to Proactive Supply Chain Management

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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Event Profile

Pharmapack Europe

Date: 7 & 8 February 2018
Venue: Paris Expo, Porte de Versailles, Paris
The event to showcase evolution and revolution in packaging and drug delivery
Pharmapack Europe is an essential event for industry insights and the latest industry innovations that are reimagining the capabilities of pharmaceutical packaging and drug delivery. Join 411 exhibitors and more than 5,290 attendees on 7 & 8 February at Paris Expo, Porte de Versailles!
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LIVE WEBCAST

Considerations for Launching a Biopharm Company in 2018
Live Webcast: Monday, January 8 at 10:00am EST
Register now


ON DEMAND WEBCASTS

The Journey to a Successful Biologic License Application
On Demand
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Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
On Demand
Learn more


Events

Pharmapack Europe

Paris, France

7–8 February 2018

9th Global Drug Delivery & Formulation Summit

Berlin, Germany

12–14 March 2018

Paperless Lab Academy 2018

Milano, Italy

20–21 March 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.

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