Pharmaceutical Technology ePT Weekly
Having trouble viewing this e-mail? CLICK HERE

PharmTech
March 10, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

PAREXEL Launches Genomic Medicine Services
IMP321 Enters Clinical Trials in Europe
Sagent Recalls Fluconazole Injection

Top Stories

New Study Examines Overspending on Oversized Cancer Drug Vials

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.
/ read more /


EMA Launches PRIority MEdicines Scheme

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.
/ read more /

advertisement

Subscribe

Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.

subscription offers
subscribe

SHARE YOUR KNOWLEDGE

PharmTech seeks objective, technical articles and papers from the bio/pharma community.

Learn how you can contribute

ADVERTISEMENT
 

Industry News

US Regulators Permit Kannalife Sciences to
Import Cannabidiol for Feasibility Studies

The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.
/ read more /


Kite Pharma Stresses Importance of
Cell-Culturing Techniques

A new four-year, $29-million program plans to improve modeling and process optimization and to change industry mindsets and workflows.
/ read more /


More Industry News

Supplier News

Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Passes FDA Inspection

The inspection confirmed that the facility was compliant with GMP guidelines.
/ read more /


PAREXEL Launches Genomic Medicine Services

The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments.
/ read more /


More Supplier News
 
advertisement
advertisement
 

Bio/Pharma News

Prima BioMed’s IMP321 Enters Clinical Trials in Europe

This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.
/ read more /


TxCell Launches Industrialization Laboratories and Technology Transfer Academy

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.
/ read more /


More Bio/Pharma News

Regulatory News

Sagent Recalls Fluconazole Injection

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.
/ read more /


Tackling Regulatory Challenges of EU’s Variations Framework

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
/ read more /


More Regulatory News
 
advertisement
advertisement
 
 

FEATURED TOPICS

DOSAGE FORMS

EMA Guideline on Setting Health-Based Exposure Limits

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
/ read more /


ASEPTIC/STERILE PROCESSING

Best Practices for Handling Antibody Drug Conjugates

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.
/ read more /

 

ANALYTICS

The Use of 2D-NMR for the Assessment of Biosimilarity

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.
/ read more /


OUTSOURCING

UV Spectroscopy Gains Use in Dissolution Testing

Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.
/ read more /


advertisement

The Role of Risk Management in Compliance Systems
In order to remain competitive and be compliant, organizations are adopting more Risk Management methodologies to categorize and prioritize compliance events by risk.
Join EtQ and Forrester Research's Chris McClean, as we conduct a deep dive into the role of Risk Management in quality and compliance, and provide analysis and research on best practices for managing risk and compliance.
Learn more

 

Webcasts

Best Practices for Effective Product Transfer

On Demand

Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma

advertisement

Natoli Engineering Company, Inc., maintains a large selection of replacement parts for nearly every tablet press on the market ready for immediate delivery worldwide. By stocking replacement parts, up to 50% less cost than the original equipment manufacturers, Natoli is able to provide the highest quality parts at exceptional prices, faster than anyone else in the industry with next-day service!
Learn more

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

On Demand

Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience


more webcasts


advertisement

How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
Register now



on pharmtech tv

PharmTech TV

Biologics Development and Manufacturing Trends

Tablet Coating

Building Biopharmaceutical Manufacturing Processes

Events

2016 PDA Annual Meeting

March 14-16, 2016

INTERPHEX 2016

April 26-28, 2016

Quality Manufacturing Conference

June 6-8, 2016


more events

advertisement

Engineering the Mechanical properties of Amorphous Spray-Dried dispersions
On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
Learn more


REFERENCE BOOKS

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
/ Click here /

More Reference Library

advertisement

Best Practices for Effective Product Transfer
On Demand
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
Learn more


eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
   

contribute | CONTACT EDITORS | CONTACT SALES | subscribe | advertise