PharmTech Europe, Weekly Alert
Having trouble viewing this e-mail? CLICK HERE

PharmTech Europe

27 October 2015

PHARMTECH.COM

CURRENT ISSUE

SUBSCRIBE

FORWARD

twitter twitter

in this issue

Hovione Expands Formulation Capabilities
FDA Warns Unimark API Facility in India
Advances in Fluorination Chemistry

Top Stories

AstraZeneca Opens New Manufacturing Facility in Russia

The site is expected to become fully operational in 2017 and will produce approximately 40 million packs and 850 million tablets of some 30 innovative medicines every year.
/ read more /


FDA Awards Grants to Expand Continuous Manufacturing

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.
/ read more /


advertisement

Subscribe

Subscribers can enjoy each full issue of Pharm Tech Europe in print, or via Pharm Tech Europe apps.

subscription offers
subscribe
advertisement

Bio/Pharma News

Merck Serono and Merck Millipore Become Merck

Merck relaunches brand identity to reflect transformation into a science and technology company.
/ read more /


Athenex Expands API Manufacturing in China

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.
/ read more /


More Bio/Pharma News

Supplier News

Hovione Expands Formulation Capabilities

Hovione acquired a formulation facility adjacent to its current process chemistry and particle engineering facility in Loures, Portugal.
/ read more /


Aesica Pharmaceuticals Announces New Service Model

CDMO Aesica rebrands to reflect its new alignment and consolidation of the Consort Medical Group, Aesica also introduced a new service to manage other CDMOs.
/ read more /


More Supplier News

advertisement

Regulatory News

FDA Warns Unimark API Facility in India

FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.
/ read more /


FDA Assesses Overview of Combination Products

The agency gives an update on the regulation of combination medical products.
/ read more /


More Regulatory News

Industry News

Giving a Boost to the Facility of the Future

Employing continuous manufacturing and data analytics will help improve the efficiency of pharmaceutical manufacturing.
/ read more /


NIH Dedicates Funds to Carbohydrate Science

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.
/ read more /


More Industry 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 /

REGULATIONS

Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
/ read more /

MANUFACTURING

Leveraging Change for Continuous Process Improvement

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

INGREDIENTS

Advances in Fluorination Chemistry for API Synthesis

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


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 /

Catalent

Site-Specific ADC Generation Using SMARTag™ Technology
Catalent's SMARTag™ technology enables biologic innovators to develop more efficacious antibody drug conjugates. It allows site-specific, programmable drug placement using proprietary cytotoxin-linkers/conjugation chemistry in an efficient and scalable process.
/ Read more /

I Holland Ltd

Do you want to increase dwell time by 50%?
XDF (eXtended Dwell Flat) is a unique patented elliptical head from which has been designed to increase time on existing presses without the need for expensive modifications.
/ Read More /

Natoli Engineering Company, Inc

Tablet Press Replacement Parts
Do you compress tablets? Request Natoli’s tablet press replacement parts and accessories catalogs for everything you need to improve the production process.
/ Read More /

Shimadzu

Changes Everything – LCMS-8060 triple quadrupole mass spectrometer expands UFMS family
Shimadzu’s new LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.
/ Read More /

Starna Scientific

Certified Reference Materials for the new USP Spectroscopy Chapter <857>
Starna Scientific has introduced a new range of Certified Reference Materials to meet the US Pharmacopeia’s revised Chapter <857> guidelines for qualifying UV and Visible spectrophotometers.
/ 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

Optimizing M&A Integration for Customer Success: The CMO Perspective

Thursday, Oct. 29, 2015 | 9 am EDT

Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.
Sponsored by AMRI


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

The Human Element in Pharma Manufacturing

Biologics Development and Manufacturing Trends

Collaborative Success Strategies for Biopharm Companies

Events

2015 AAPS Annual Meeting

October 25–29, 2015 | Orlando, FL, USA

The Universe of Pre-filled Syringes & Injection Devices

November 3–4, 2015 | Vienna, Austria


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
contribute | CONTACT EDITORS | CONTACT SALES | subscribe | advertise