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PharmTech Europe

10 November 2015

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Warning Letter Cites AFP for GMP Violations
Sanofi Recalls Auvi-Q Due
IMA Presents New Tablet Press Range

Top Stories

Harmonization of Pharmacopoeial Standards Stresses on Delamination

The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity of pharmaceutical glassware, including bottles, vials, cartridges, and syringes.
/ read more /


GEA Collaborates with GSK on POD-Based Mini-Factories

GEA has entered into a collaboration with GSK to further develop self-contained, POD-based mini-factories for the manufacture pharmaceutical oral solid dosage forms.
/ read more /

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Industry News

Warning Letter Cites AFP for GMP Violations

FDA noted multiple manufacturing, testing, and labeling violations at American Family Pharmacy’s Indianapolis facility.
/ read more /


Pharma Trends—From Biologics for Niche Patient Populations to Isolators and Containment for HPAPI Manufacturing

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry.
/ read more /


More Industry News

Bio/Pharma News

Sanofi Recalls Auvi-Q Due to Dosage Concerns

The company is voluntarily recalling the epinephrine injection, USP because of potential inaccurate dosage delivery.
/ read more /


ProBioGen and Bio Farma Plan Indonesian Production of Trastuzumab

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.
/ read more /


More Bio/Pharma News

Supplier News

IMA Presents New Tablet Press Range, Prexima

Prexima 80 is designed for R&D and small batch production; the single-sided Prexima 300 is for medium production output; and the double-sided Prexima 800 is for high production output.
/ read more /


Catalent Expands Cold-Chain Capacity at Shanghai Facility

Catalent announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China.
/ read more /


More Supplier News

Regulatory News

IPEC-America Suggests Improvements to FDA's Inactive Ingredients Database

Representatives of the excipients industry responded to FDA's request with new ways to make the IID more relevant and useful.
/ read more /

 

FDA Releases Liposome Drug Product Guidance

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.
/ read more /


More Regulatory News

FEATURED TOPICS

FORMULATION

Characterization and Formulation Screening of mAb and ADCs by High-Throughput DLS

High-throughput dynamic light scattering effectively screens for optimal ADC formulations by investigating the effects of buffer conditions and temperature on aggregation.
/ read more /

INGREDIENTS

Advances in Fluorination Chemistry for API Synthesis

Safer solid reagents and new coupling chemistry are important developments.
/ read more /

MANUFACTURING

Leveraging Change for Continuous Process Improvement

Managing change and overcoming employee resistance and fear requires a proactive approach.
/ read more /

REGULATIONS

Biosimilar Development Continues to Challenge FDA and Industry

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.
/ read more /


Product/Service Profiles

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 /

Shimadzu

Universal solution for automated HPLC method development
Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.
/ Read more /

Wickham Laboratories Ltd

MALDI-ToF Rapid Microbial Identification
GMP/GLP compliant testing laboratory, Wickham Laboratories Ltd, announces the introduction of new MALDI-ToF, rapid microbial identification service.
/ Read more /


Event Profile

CPhI India

Meet 32,000 Pharma Professionals @South Asia's largest Pharma Expo
1st – 3rd December 2015
Bombay Convention & Exhibition Centre, Mumbai, India
/ Learn more /


Webcasts

Strategies to Accelerate Early Phase Clinical Trials

On Demand

Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS


Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon


more webcasts

on pharmtech tv

PharmTech TV

Blow-Fill-Seal for Aseptic Processes

Biologics Development and Manufacturing Trends

The Human Element in Pharma Manufacturing

Working with CMOs and CDMOs

Events

Outsourcing/Contract Manufacturing

November 17–18, 2015 | Copenhagen, Denmark

Vaccines

December 1-2 | Berlin, Germany


more events

REFERENCE LIBRARY

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
/ 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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