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PharmTech Europe

14 June 2016

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Top Stories

US and EU Regulators Seek to Reduce Pharma Inspections

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
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Using a New CRISPR Effector to Edit RNA

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.
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Industry News

MilliporeSigma Surveys Biopharmaceutical Executives

MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.
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Diverging Results in Clinical Success Rates for Biologics

An article in Nature Reviews Drug Delivery reports the clinical success rates of biologics, and these numbers differ from those recently highlighted in a similar BIO study.
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EXPERT INTERVIEW

Adam Feinberg, associate professor of Biomedical Engineering at Carnegie Mellon University, sat down with Pharmaceutical Technology to discuss challenges in 3D bioprinting.

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Regulatory News

EMA Encourages Advanced Therapies

The agency published a report on fostering the development of advanced therapy medicinal products.
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PSUR Repository Becomes Mandatory in EU

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
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Bio/Pharma News

Fujifilm Diosynth Announces Collaboration With MSD on Large-Scale Biologics Facility

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.
/ read more /


Mylan and Biocon's Biosimilar to Herceptin Demonstrates Comparable Efficacy

Results of the HERITAGE study were announced at the 2016 American Society of Clinical Oncology meeting.
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Supplier News

CMC Biologics Will Manufacture F-star mAb² Bispecific Antibodies

The collaboration will provide GMP manufacturing ahead of future clinical studies.
/ read more /


Catalent Opens cGMP Facility in Japan

The company opened a facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.
/ read more /


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Bio/Pharma in China
New Initiatives, New Opportunities

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FEATURED TOPICS

VACCINES

Building a Better Self-Injection Solution

Experts discuss the key considerations in the development of an autoinjector.
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FACILITIES

Deciding When To Use Modular Construction

Different types of modular systems have advantages and disadvantages.
/ read more /

PEER-REVIEWED RESEARCH

Qualifying Personnel to Visually Inspect Cleaned Equipment Part II: Small vs. Large Group Training

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
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MANUFACTURING

Integrating Single-Use Systems in Pharma Manufacturing

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.
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Product/Service Profile

ABITEC Corporation

CAPMUL® - Where Formulation Begins™
ABITEC Corporation is dedicated to the advancement of essential bioavailability enhancement and formulation development technology. ABITEC synthesizes and produces lipid based excipients to enhance bioavailability of poorly water soluble and poorly permeable molecules for the pharmaceutical industry.
/ Read more /

Catalent

Fast Dissolve Oral Dosing of Macromolecules
Catalent’s Zydis® orally disintegrating tablet (ODT) fast-dissolve formulation is a unique, freeze-dried oral dosage form that disperses instantly in the mouth, requiring no water.
/ Read more /

EtQ Inc

EtQ is the leading quality, compliance and EHS management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration.
/ Read more /


Webcasts

Best Practices for Effective Product Transfer

On Demand

Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma


Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience


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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 Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /


More Reference Library

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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