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PharmTech Europe
05 November 2019

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TOP STORIES

Sartorius Acquires Danaher Life Science Businesses for $750 million

The transaction is set to be completed in the first quarter of 2020.
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BioInvent Enters into Production Agreement Expected to Generate $30 million

The company will produce the anti-HER3 antibody drug HMBD-001 for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.
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Industry News

SP Industries Acquires Spanish Sterile Filling Line Company i-Dositecno

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.
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WuXi STA Announces Successful EMA Inspection of Jinshan Facility

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan's Pharmaceutical and Medical Device Agency for an innovative drug.
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Regulatory News

Three More Companies Issue Recalls Due to NDMA Impurities

Dr. Reddy's, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.
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AptarGroup Receives FDA Approval for Packaging Solution for HIV Prevention Medicine

The packaging solution works to protect drugs with a 3-Phase Activ-Polymer solution, a technology that is customized for the drug developer's formulation, offers a broad spectrum of specific drug protection, and oxygen and odor scavenging.
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More Regulatory News
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Bio/Pharma News

Takeda Acquires Global License for Celiac Disease Therapy for $420 million

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.
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GE Healthcare Launches Viral Vector-Based Gene Therapy Manufacturing

GE Healthcare Life Sciences' KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.
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More Bio/Pharma News

Supplier News

Gerresheimer Renovates Glass Production Facility

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.
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Legacy Pharmaceuticals to Increase Employee Headcount to 250 By Year's End

The company will aim to increase its employee headcount to meet the demand for one-stop-shop drug products manufacturing services.
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FEATURED TOPICS

QUALITY/REGULATIONS

Using Software in Process Validation

Software systems can help validate pharmaceutical manufacturing.
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ANALYTICS

Distribution of Data: The Central Limit Theorem

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
/ read more /

OUTSOURCING

Best Practices for Studying Stability in Biologics

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing programme.
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VIEWPOINTS

Image Repair Must Get to the Root Cause

Climbing out of a reputation hole starts with adopting a quality culture.
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Events

CPhI Worldwide

Frankfurt, Germany

5-7 November 2019

Outsourcing & Supply Chain–A 360° View

Lisbon, Portugal

12-13 November 2019

Validation University

Cork, Ireland

25-27 November 2019

more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.

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