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PharmTech Europe

2 August 2016

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Top Stories

GSK Unveils GBP275M Investment Plans in UK Manufacturing

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.
/ read more /


Eli Lilly CEO Announces Retirement

John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.
/ read more /


Open-Access Technology Seeks to Make Drug Discovery Easier

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.
/ read more /


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EXPERT INTERVIEW

David Mayers, president of Wellspring Pharma Services sat down with Pharmaceutical Technology to discuss the manufacture of controlled substances.

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Industry News

Global Fight Against Antimicrobial Resistance Gets Underway

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.
/ read more /


Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.
/ read more /


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Regulatory News

FDA Detects Deviations from CGMP at Denmark's ALK-Abello

The company manufactures biological drug products and intermediates for the allergy vaccine market.
/ read more /


Darzalex Secures Breakthrough Therapy Designation

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.
/ read more /


More Regulatory News

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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
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Bio/Pharma News

Merck Returns Rights to Allergy Tablets Back to ALK-Abello

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.
/ read more /


AstraZeneca Begins Phase I Testing of its RNA-Based Therapeutic with Moderna

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.
/ read more /


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Supplier News

Saneca Pharma Secures Contract Manufacturing Agreement with Xantis Pharma

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.
/ read more /


Powder Systems Limited Installs High-Containment Filter Dryer in Australian API Manufacturing Plant

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.
/ read more /


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FEATURED TOPICS

FACILITIES

Planning a Biologics Facility Start Up

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
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SUPPLY CHAIN

Ensuring Supply Chain Safety

Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
/ read more /

GMPs

More inspections, and regulator collaboration, offshore

China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
/ read more /

PACKAGING

Solid-Dosage Packaging Trends

Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.
/ read more /


Product Profile

DIOSNA Dierks & Söhne GmbH

DIOSNA Laboratory/Pilot Mixer Granulator P/VAC 10-80 RC
The P/VAC 10-80RC is designed by DIOSNA to achieve a rapid exchange of product bowls for mixing, granulating and even vacuum drying of clinical batches in the pharmaceutical industry.
/ Read more /

Műller GmbH

The new AGILO series

Stainless steel pallet trucks:  New components in the Müller portfolio.
/ Read more /

Webcasts

Employing a Lean Lab Approach to Optimize Lab Processes: Part 1 "Work smarter not harder"

On Demand

When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Sponsored by Mettler Toledo


Understanding Water Activity to Ensure Microbial Safety and Product Stability

On Demand
In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed.
Sponsored by Aqua Lab by Decagon


more webcasts

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 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.
/ Click here /


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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