Pharmaceutical Technology ePT Weekly
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PharmTech
November 01, 2018
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In this issue:

Considering Twin-Screw Granulation

Merck KGaA Adds New Packaging Center

Efficiency Demands Drive Advances in API Labs


Top Stories

Biogen and Samsung Bioepis Launch Humira Biosimilar in Europe

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie's blockbuster Humira (adalimumab).
/ read more /


Lonza Acquires a Controlling Stake in Octane Biotech for Cell Therapy Technology

The acquisition allows Lonza to further develop technology for scalable autologous cell-therapy manufacturing.
/ read more /

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Industry News

Chip-Based Device May Transform Spectrometry

Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.
/ read more /


CPhI Worldwide Survey Indicates 2019 Should be a Strong Year for Pharma

The latest CPhI Worldwide survey results have revealed a promising outlook for the global pharma economies.
/ read more /


More Industry News
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Supplier News

SGS Adds In Vitro Toxicology Testing at Canadian Lab

The investment in the company's Mississauga, Canada, laboratory includes an expansion of existing cell/tissue culture capabilities, flow cytometry, mass spectrometry facilities, and more.
/ read more /


Quotient Sciences Opens New Early-Phase Formulation and Manufacturing Facility

The company has expanded its operations in the United States with the opening of a new 45,000-ft2, early-phase formulation and manufacturing facility located in Garnet Valley, PA.
/ read more /


More Supplier News

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Bio/Pharma News

Merck KGaA Adds New Packaging Center

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.
/ read more /


AbbVie, Galapagos Restructure CF Collaboration

AbbVie will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF).
/ read more /


More Bio/Pharma News
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Important Microbiology Testing Information Delivered Directly to your Inbox
Receive informative microbiology testing resources from Eurofins Lancaster Laboratories. Stay up-to-date with articles, technical whitepapers, webinars, conferences, presentations and a virtual tour of our microbiology labs. Register now to get started.


Regulatory News

FDA Approves New Flu Treatment

The agency has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza.
/ read more /

 

Tennessee OTC Company Receives Consent Decree

A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.
/ read more /


More Regulatory News

FEATURED TOPICS

OUTSOURCING

Outsourcing Development: Small-Scale to Commercial

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
/ read more /

QUALITY SYSTEMS

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
/ read more /



MANUFACTURING

Considering Twin-Screw Granulation

A twin-screw extruder can be used as a continuous wet granulator.
/ read more /

DRUG DEVELOPMENT

Efficiency Demands Drive Advances in API Labs

Integration of new modeling and analytical tools with flow chemistry are notable trends.
/ read more /


Product Profile

Agilent

Agilent Provides Microparticles for High-Performance IVD Assays
Agilent provides magnetic and nonmagnetic beads tailored to the needs of manufacturers of in-vitro diagnostic (IVD) assays.
/ Read more/


UPCOMING WEBCASTS

Utilizing Spray-Dried Dispersion Technology for Bioavailability Enhancement: Overview and Case Studies
Thursday, November 15, 2018 at 11am EST|8am PST|4pm GMT|5pm CET
Register now


Validating H2O2 Bio-Decontamination in Rooms and Isolators
Wednesday, November 14, 2018 at 11am EST|8am PDT|4pm GMT|5pm CET
Register now



ON DEMAND WEBCASTS

Insoluble APIs Scaring You? Don't be Afraid of Nanoparticles!
On Demand
Learn more


Planning Successful Launches of Complex Drug Products
On Demand
Learn more


Sterility Testing: Best Practices and Use of Isolator Technology
On Demand
Learn more


Successfully Navigating the Analytical Environment of Complex Generic APIs
On Demand
Learn more


Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method
On Demand
Learn more


Facing Inactive Ingredient Database Challenges? Navigating the Complexity for Successful Regulatory Filings
On Demand
Learn more


Events

scwish:pharma

November 1–2, 2018

ISPE Annual Meeting & Expo

November 4–7, 2018

Twin Screw Extrusion Workshop

November 28–29, 2018

more events

AAPS PharmSci 360 Exhibitor Preview


Mikart

Mikart specializes in the development, manufacturing, and packaging of solid-dose and liquid-oral dose products.
/ Read more/

Quotient Sciences

Quotient Sciences is dedicated to accelerating the development of new drugs for patients around the world.
/ Read more/

About Patheon and Fisher Clinical Services

Thermo Fisher Scientific's Patheon and Fisher Clinical Services brands provide industry-leading solutions for drug development, clinical trial logistics, and commercial manufacturing to customers of all sizes.
/ Read more/

USP

USP is a scientific, nonprofit organization that sets standards for quality medicines. USP standards are the industry benchmark because of the robust scientific process used in their development.
/ Read more/


New Products and Services


VAI

VAI's manufacturing and testing operations mirror current GMP/GLP standards. Our products and services include a comprehensive line of disinfectants, sporicides, consulting, and more.
/ Read more/

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.

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