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PharmTech Europe

29 March 2016

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Top Stories

NIH Investigational Dengue Vaccine Proves 100% Effective

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.
/ read more /


MMIP Launches Advanced Therapy Manufacturing Taskforce

The taskforce will work to identify opportunities to advance therapy manufacturing and the supply chain in the UK.
/ read more /


INTERPHEX 2016 KEYNOTE SERIES:
SOLID DOSAGE DEVELOPMENT AND MANUFACTURING

Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on innovations in solid dosage development and manufacturing at INTERPHEX 2016.

LEARN MORE
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Industry News

Pharmapack Europe Addresses Key Industry Trends

The conference discussed key industry issues including serialization, innovation, and patient-centricity.
/ read more /


Market Opportunities to be Explored at CPhI Japan

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.
/ read more /


More Industry News

Regulatory News

European Pharmacopoeia Revises WFI Monograph

The agency now allows production of water for injection by non-distillation technologies.
/ read more /


FDA Enhances Label Warnings for Immediate-Release Opioids

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.
/ read more /


More Regulatory News
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Bio/Pharma News

Pfizer Joins the Human Vaccines Project

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.
/ read more /


Studies Demonstrate Remsima Efficacy and Safety Following Switch from Infliximab

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.
/ read more /


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Supplier News

Novasep and GTP Partner on Monoclonal Antibody Development

The partnership aims to facilitate the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
/ read more /


Vetter Breaks Ground on New Production Facility

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.
/ read more /


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FEATURED TOPICS

ANALYTICS

Concerns Mount Over Data Integrity and Compliance Issues Abroad

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.
/ read more /

OUTSOURCING

Specialty Markets and Services Drive API Growth

As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.
/ read more /

MANUFACTURING

Industry Expert Q&A with David A. Steil

Q&A with David A. Steil, pharmaceutical market manager, Camfil Air Pollution Control.
/ read more /

QUALITY

Building Consensus for E&L Testing Standards

Standardized testing protocols are crucial for acceptance of single-use systems.
/ read more /


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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping

LIVE WEBCAST: US: Wednesday, April 20, 2016 at 11 am EDT and EU: Wednesday, April 27, 2016 at 11 am CEST
In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Free registration



KEYNOTE SERIES AT INTERPHEX 2016

At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.

Overcoming Bottlenecks in Biopharmaceutical Development

In a panel discussion, Industry experts will discuss how technology advances are addressing challenges in biopharmaceutical development including quality control of raw materials, implementation of single-use technologies, process monitoring, and downstream purification.
Tuesday, April 26, 10:15 am to 11:45 am
Learn more

Contract Services Market: 2016 Update

How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am
Learn more

Strategies and Innovations to Reduce Drug Shortages and Improve Availability of Medicines

Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies.
Wednesday, April 27, 1:30 – 3:15 pm
Learn more

Panel Discussion: Addressing Sterile Manufacturing Challenges

Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 4:30 pm
Learn more


Webcasts

Comparing Performance of Gelatin Capsules and the Next Generation of HPMC Capsules

On Demand

New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC's role as a functional excipient.
Sponsored by Capsugel


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


more webcasts

on pharmtech tv

PharmTech TV

Cell Therapies

Biologics Development and Manufacturing Trends

FDA Applications and New Guidance Documents

Events

BIO Europe Spring 2016

4-6 April, 2016 | Stockholm, Sweden

Global Drug Delivery and Formulation Summit

23-25 May, 2016 | Berlin, Germany

Chemspec Europe 2016

1-2 June, 2016 | Basel, Switzerland


more events

REFERENCE LIBRARY

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

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

2016 Solid Dosage Drug Development and Manufacturing eBook

New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.

more ebooks
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