Pharmaceutical Technology ePT Weekly
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PharmTech
October 27, 2016
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In this issue

NJIT Researchers Honored for API Technology

Merck Donates Millions of Praziquantel Tablets

FDA Tackles Cellular, Gene Therapies

Top Stories

Service Gradually Restarts at BASF Plant in Ludwigshafen

Following a fire, BASF announced that steamcrackers are slowly being restarted at the company's plant in Ludwigshafen.
/ read more /


FDA Highlights Flexibility in Approving Rare Disease Therapies

FDA leaders insist that the decision to approve Sarepta's Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
/ read more /

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Industry News

Researchers Propose a Flexible Method for Gene Therapy Manufacture

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.
/ read more /


NJIT Researchers Honored for API Coating Technology

The researchers were awarded the Thomas Alva Edison Patent Award for a solventless method for coating APIs.
/ read more /


More Industry News
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Supplier News

Horizon Discovery Signs Subscription-Based Licensing Agreement for Biomanufacturing Cell Lines

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.
/ read more /


Catalent Breaks Ground for Expanded Biologics Facility

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.
/ read more /


More Supplier News
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Bio/Pharma News

Merck Donates Millions of Praziquantel Tablets to Fight Schistosomiasis

Merck is providing WHO with approximately 10 million tablets for Ivory Coast.
/ read more /


Heat Biologics and University of Miami Collaborate on Zika Vaccine Development

Heat Biologics will collaborate with the University of Miami on the development of a Zika vaccine using the company's gp96 platform.
/ read more /


More Bio/Pharma News

Regulatory News

ICH Introduces Two New Guidelines

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
/ read more /


FDA Tackles Cellular, Gene Therapies

FDA's new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
/ read more /


More Regulatory News



FEATURED TOPICS

MANUFACTURING

Improving Feeder Performance in Continuous Pharmaceutical Operations

Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.
/ read more /

STANDARDS & REGULATION

Manufacturers Face Major Changes under PDUFA VI

Efforts to accelerate drug development will alter fee structure and require ready production sites.
/ read more /


OUTSOURCING

Fill/Finish Outsourcing

This key bioprocessing segment is expecting continued growth.
/ read more /

PACKAGING

Protecting Parenterals in Primary Packaging

Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.
/ read more /


AAPS Exhibitor Guide

Specialty Measurements Inc. (SMI)

SMI, founded in 1982, brings over 30 years of engineering excellence to the industry.
AAPS Booth # 721
/ Learn more /

MG America

The PLANETA 200 Capsule Filler can produce 200,000 capsules/hr, and features a highly configurable platform suitable for a wide array of production requirements—including an ability to fit several dosing units simultaneously, enabling one capsule to be filled with differing products.
AAPS Booth # 1208
/ Learn more /

Fette Compacting America

Capable of producing 400,000 capsules/hr, Fette's FEC40 is the world's fastest capsule filling machine.
AAPS Booth # 1133
/ Learn more /

IMA North America

IMA Group is world leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceuticals, cosmetics, tea, coffee, and food.
AAPS Booth # 545
/ Learn more /

MPI Research

MPI Research is a high-quality organization that provides discovery, preclinical, and clinical services to the biopharmaceutical, medical device, animal health, and chemical industries.
AAPS Booth # 1249
/ Learn more /


UPCOMING WEBCASTS

Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
Live Webinar: Wednesday, November 16 - 2016 at 1:00 pm EST
Register now


Risk Management Strategies for Quality Management in the Pharmaceutical Industry
Live Webinar: Wednesday, November 9 - 2016 at 2:00 pm EST
Register now


Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Live Webinar: Thursday, November 3 - 2016 at 8:00 am PDT
Register now


ON DEMAND WEBCASTS

Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
On Demand
Learn more


A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
On Demand
Learn more


Strategies for IND Filing Success
On Demand
Learn more


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


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 presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ 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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