Pharmaceutical Technology ePT Weekly
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PharmTech
August 09, 2018
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In this issue:

Takeda Acquires TiGenix

Leistritz to Host Annual Twin Screw Extrusion Workshop

FDA Publishes Guidance on Developing New Treatments for Opioid Use Disorder


Top Stories

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

More consistent and reliable production processes are critical for advancing innovative treatments.
/ read more /


Bayer to Sell Prescription Dermatology Unit

Denmark-headquartered pharmaceutical company LEO Pharma is set to acquire Bayer's prescription treatment portfolio.
/ read more /


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Industry News

AuroMedics Pharma Issues Voluntary Recall Due to Glass and Silicone Particulates

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
/ read more /


Diabetes Drugs Shown to Help Macrophages Control Inflammation

Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.
/ read more /


More Industry News
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Supplier News

Leistritz to Host Annual Twin Screw Extrusion Workshop

Leistritz's Twin Screw Extrusion Workshop, taking place Nov. 28–29, 2018 in Clifton and Somerville, NJ, will feature classroom sessions and extrusion demonstrations.
/ read more /


 

MilliporeSigma, InnoCore to Partner on Biodegradable Drug Delivery Platform

The companies will collaborate to bring InnoCore Pharmaceuticals' proprietary SynBiosys biodegradable polymer platform to market.
/ read more /


More Supplier News
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Make Compliance a Competitive Advantage:
Are you searching for a CDS software that simplifies meeting the latest demanding regulations? With Thermo Scientific Chromeleon CDS software, sequence-level data organization and audit trails tracking all actions in the software — including CDS-related external events – you can defend your data with utmost confidence allowing you to focus on the important work of your lab. Visit resource center. Learn More

Bio/Pharma News

Takeda Acquires TiGenix

Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical.
/ read more /

 

Amgen Breaks Ground on Next-Generation Biomanufacturing Plant

The company broke ground on its $200-million, 120,000-sq-ft biomanufacturing plant in West Greenwich, RI.
/ read more /


More Bio/Pharma News
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Early Bird Registration Available: Full Day E&L Symposium:
Register for Eurofins Lancaster Laboratories' 2nd Annual Extractables & Leachables Symposium for Drugs and Devices on Thursday, September 20th in San Francisco, CA. Don't miss this opportunity to learn best practices, gain insight on regulations and hear case studies from Sanofi and Janssen.Learn More

Regulatory News

EC Approves Pfizer's Biosimilar to Roche's Herceptin

The European Commission (EC) approved Pfizer's Trazimera (trastuzumab), a biosimilar to Roche's Herceptin, to treat certain breast and gastric cancers.
/ read more /

 

FDA Publishes Guidance on Developing New Treatments for Opioid Use Disorder

The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.
/ read more /


More Regulatory News
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2018 PDA Universe of Pre-filled Syringes and Injection Devices:
October 8-9, 2018 | Loews Royal Pacific| Orlando, FL
At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices, October 8-10 in Orlando, Florida, industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices. Learn More

FEATURED TOPICS

REGULATORY WATCH

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
/ read more /

OUTSOURCING

Reducing Development Timelines and Costs

Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.
/ read more /

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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment. www.cbinet.com/cleaning


QUALITY SYSTEMS

What's in Your SOP?

SOPs need to reflect a company's specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
/ read more /

SCALE-UP

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.
/ read more /

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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems. www.cbinet.com/dataintegrity


UPCOMING WEBCAST

A Collaborative Approach for Successful Method Transfers and Routine Quality Control Batch Release Testing
Tuesday, August 21, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now

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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry. Learn More


ON DEMAND WEBCASTS

How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, and Risk
On Demand
Learn More


Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
On Demand
Learn More


How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
On Demand
Learn more


Best Practices for Highly Potent API (HPAPI) Development and Manufacturing
On Demand
Learn more


Multiparticulate Formulation Strategies for Pediatric Drugs
On Demand
Learn more


Events

MES 2018:13th Annual Global Forum on Manufacturing Execution Systems

August 13–14, 2018

4th Annual Data Integrity Validation

August 15–16, 2018

Cleaning Validation

August 21–23, 2018

more events

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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