Pharmaceutical Technology ePT Weekly
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PharmTech
October 20, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

In this issue

FDA Officials Warn Japanese API Manufacturer

BASF Ludwigshafen Plant Explosion

Pfizer to Begin Shipping Inflectra in US

Top Stories

Pfizer Comes Up Short in Lyrica Patent Battle

A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica's pain patent.
/ read more /


Catalent Collaborates with Moderna

The companies will collaborate on the manufacture of personalized cancer vaccines.
/ read more /


EXPERT INTERVIEW

Richard Denk, head sales containment at SKAN, spoke with Pharmaceutical Technology about trends in handling high potency APIs.

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Industry News

Study Demonstrates Potential Method for Treating Congenital Diseases In Utero

A new study proposes a way to potentially treat congenital diseases in utero.
/ read more /


FDA Officials Issue Warning Letter to Japanese API Manufacturer

FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company's laboratory and equipment.
/ read more /


More Industry News
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Supplier News

BASF Ludwigshafen Plant Explosion Leaves Three Dead

An explosion and fire at a BASF plant in Ludwigshafen that left three dead, resulted from work on a pipeline containing ethylene and propylene product.
/ read more /


Recipharm to Open New GLP Bioanalysis Laboratory in Sweden

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.
/ read more /


More Supplier News

Bio/Pharma News

Pfizer to Begin Shipping Inflectra in US

The company announced plans to begin shipping Inflectra to the US market in late November 2016.
/ read more /


Gamida Cell Receives Breakthrough Therapy Designation For NiCord

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.
/ read more /


More Bio/Pharma News


Regulatory News

Scottish Company Receives USFDA Warning Letter

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
/ read more /

 

FDA Warns Swiss Company

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
/ read more /


More Regulatory News



FEATURED TOPICS

QUALITY

Protein Impurities Pose Challenges

Multiple methods are required for detecting and removing protein impurities.
/ read more /

API SYNTHESIS & MANUFACTURING

The Search for Practical and Economical Catalysts

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.
/ read more /


FORMULATION

Reverse Engineering a Pressurized Metered Dose Inhaler

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.
/ read more /

SUPPLY CHAIN

Tracking a Global Problem

A number of organizations have analyzed and estimated the size of pharma's counterfeit and diversion problem.
/ read more /


AAPS Exhibitor Guide

Qualicaps

Qualicaps® has over a century of capsule manufacturing experience and a strong record of pioneering in new forms of drug administration.
AAPS Booth # 827
/ Learn more /

SE Tylose USA

SE Tylose USA, Inc. is a wholly owned subsidiary of Shin-Etsu Chemical Co., Ltd. and is responsible for the sales, distribution and technical support of our cellulose ether products in NA.
AAPS Booth # 749
/ Learn more /

Chemic Laboratories Inc.

Chemic Laboratories, Inc. is a full service cGMP/GLP contract analytical chemistry laboratory.
AAPS Booth # 314
/ Learn more /

GlobePharma

GlobePharma has spent 20 years Innovating the Industry Standard.
AAPS Booth # 309
/ Learn more /


NEW PRODUCTS & SERVICES

Ross, Charles & Son Company

Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise, with stainless steel 304 wetted parts.
/ Learn more /


UPCOMING WEBCASTS

Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
Live Webinar: Wednesday, November 16 at 1:00pm EST
Register now


Risk Management Strategies for Quality Management in the Pharmaceutical Industry
Live Webinar: Wednesday, November 9 at 2:00pm EST
Register now


Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Live Webinar: Thursday, November 3 at 8:00am PDT
Register now


Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
Live Webinar: Wednesday, October 26 at 11:00am EDT
Register now


A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
Live Webinar: Tuesday, October 25 at 2:00pm EDT
Register now


Strategies for IND Filing Success
Live Webinar: Friday, October 21 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Implementing On-Dose Anticounterfeiting Technologies for Solid-Dose Drug Products
On Demand
Learn more


Don't Let Your Diluent be the Weakest Link in Your Drug Product
On Demand
Learn more


Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
On Demand
Learn more


Events

Global Conference on Pharmacy and Pharmaceutical Sciences Education

November 7–8, 2016

AAPS Annual Meeting and Exposition

November 13–17, 2016

Pharma Blockchain Bootcamp

November 16, 2016

more events

REFERENCE BOOKS

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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