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PharmTech Europe

22 September 2015

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Top Stories

FDA Issues Import Ban for Indian Drug Manufacturer

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
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AstraZeneca Buys Amgen's Biologics Manufacturing Facility

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.
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Bio/Pharma News

Nexvet Secures Biomanufacturing Facility for Veterinary Biologics

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.
/ read more /


AstraZeneca and the University of Manchester Team Up on Bioinformatics Venture

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.
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More Bio/Pharma News

Industry News

Pharma Urged to Embrace Green Chemistry

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.
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MGB Biopharma Wins Scottish Business Award

MGB Biopharma, a biopharmaceutical company specializing in the development of novel anti-infectives to antibiotic resistance, has been named a winner in the 2015 Scottish Business Insider Deals & Dealmakers Awards.
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More Industry News

Supplier News

Acquisition Combines Lab Glassware Suppliers Wheaton and Duran Group

The Duran Group’s acquisition of Wheaton combine two brands of laboratory consumables.
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Abenza Acquires US CDMO PacificGMP

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.
/ read more /


More Supplier News

Regulatory News

FDA Cites India API Facility For CGMP Violations

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
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FDA Expands Warning on BD Syringes

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.
/ read more /


More Regulatory News

FEATURED TOPICS

QUALITY

Quality by Design in Solid-Dosage Manufacturing

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.
/ read more /

FACILITIES

Generating Savings from Room Declassification

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.
/ read more /

FORMULATION

A Matter of Taste

Industry experts share insights about the various approaches used in taste masking and the challenges involved.
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EUROPEAN REGULATIONS

Collaborating on GMP Inspections

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.
/ read more /

PEER-REVIEWED

Establishing Limits for Dermal Absorption of Elemental Impurities

Current guidance does not address dermal exposure, resulting in a simplistic approach to limit setting.
/ read more /

TROUBLESHOOTING

Cleaning a Vial Filling Line

Appropriate cleaning procedures are crucial for any cGMP aseptic or sterile manufacturing process; operators share best practices for cleaning.
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Product/Service Profiles

Agilent

Agilent CrossLab –From Insight to Outcome
Laboratories today face complex scientific and business challenges that require key insights into laboratory operations.  Agilent CrossLab Enterprise Solutions provide these insights by leveraging laboratory operations data to help you dramatically improve scientific and business outcomes across your local, regional or global laboratory enterprise. Agilent CrossLab Enterprise Solutions -- focused on your organization’s goals.
/ Read More /

MPI Research

MPI Research provides preclinical and clinical services to agricultural, environmental science, biopharmaceutical, medical device, animal health, and chemical industries. MPI serves Sponsors globally. Strategic partners include inviCRO and 3D Imaging, and MPI acquired Jasper Clinical Research & Development in 2014, a respected clinical research organization that provides early-stage human clinical testing.
/ Read More /



Event Profile

Pharma EXPO

Winning Solutions for the Entire Pharmaceutical Lifecycle
Pharma EXPO brings together solutions designed to give pharmaceutical, biopharmaceutical, medical device and nutraceutical companies like yours a competitive edge. Plus, the co-location with PACK EXPO Las Vegas provides the opportunity to explore processing and packaging ideas from all other industries.
/ Register now at pharmaexpo.com /


Webcasts

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

Wednesday, Oct. 7 2015 | 2–3 pm EDT

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


Pharma Supply Chain Security: Are You in Control?

On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.


more webcasts

on pharmtech tv

PharmTech TV

Trends and Concerns in Capsule Production

Application of External Lubrication in Tablet Production

Building Biopharmaceutical Manufacturing Processes

Events

PDA/FDA Meeting 2015

September 28–30, 2015 | Washington, DC, USA

BIOTECHNICA 2015

October 6–8, 2015 | Hannover, Germany

CPhI Worldwide

October 13–15, 2015 | Madrid, Spain


more events

REFERENCE LIBRARY

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
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