Pharmaceutical Technology ePT Weekly
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PharmTech
July 19, 2018
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In this issue:

Call for Entries: 2018 CPhI Pharma Awards

Selecting Excipients for Controlled Release

EMA Sees Gaps in Pharma's Readiness for Brexit


Top Stories

AbbVie Signs Patent License with Mylan for Humira Biosimilar

AbbVie will grant Mylan license to launch a biosimilar to AbbVie's Humira.
/ read more /


FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

FDA is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
/ read more /


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Industry News

Cross-Industry Expertise Can Promote Manufacturing Improvements

Report predicts PAT, NIRS, continuous bioprocessing, and a 'technological arms race' could improve biopharma manufacturing efficiencies.
/ read more /


Call for Entries: 2018 CPhI Pharma Awards

Annual awards program recognizes innovation in bio/pharmaceutical drug development and
manufacturing.
/ read more /


More Industry News

Supplier News

Catalent Implements Optofluidic Platform for Cell-Line Development

Catalent Biologics will adopt Berkeley Lights' Beacon optofluidic platform for its cell-line development workflow.
/ read more /


Moderna Opens Manufacturing Site for mRNA Therapeutics

Moderna's new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.
/ read more /


More Supplier News

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Bio/Pharma News

Otsuka to Acquire Visterra for $430 Million

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.
/ read more /


 

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.
/ read more /


More Bio/Pharma News

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Next Generation Raman imaging
Renishaw has decades of experience developing flexible Raman systems that give reliable results, even for the most challenging measurements. Interested in learn more about our Raman systems? Come visit us at the M&M Show in Baltimore on August 5th – August 9th at Booth #408 and the ACS National Meeting & Expo in Boston on August 19th – August 23rd at Booth #2322.
Learn more

 

Regulatory News

EMA Sees Gaps in Pharma's Readiness for Brexit

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom's departure.
/ read more /

 

Drugs Containing Valsartan Recalled

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
/ read more /


More Regulatory News

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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


FEATURED TOPICS

PACKAGING

Selecting Primary Packaging for Parenterals

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.
/ read more /

MANUFACTURING

Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.
/ 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

 

EXCIPIENTS

Selecting Excipients for Controlled Release

With the right excipients, formulators can control when, where, and how an API is released.
/ read more /

QUALITY SYSTEMS

Responding to FDA CAPA Requests

Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
/ read more /


UPCOMING WEBCAST

How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, and Risk
Tuesday, August 7, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
Tuesday, July 31, 2018 at 10am EDT | 3pm BST | 4pm CEST
Register now


How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
Wednesday, July 25, 2018 at 11 am EDT | 8 am PDT | 4 pm BST | 5 pm CEST
Register now


A Short Journey to Bio/Pharmaceutical UHPLC Method Transfer Success
Tuesday, July 24, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

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


Multiparticulate Formulation Strategies for Pediatric Drugs
On Demand
Learn more


Engineering and Manufacture of Second Generation ADCs: Tools and Techniques
On Demand
Learn more


A Rational Approach to Excipient Selection
On Demand
Learn more


E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure
On Demand
Learn more


Events

The 67th Annual Denver X-ray Conference

August 6–10, 2018

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

August 13–14, 2018

4th Annual Data Integrity Validation

August 15–16, 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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