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  Pharmaceutical Technology Europe E-Alert
 
12 August 2011

IN THIS ISSUE
• API inspections
• Pfizer partnership
• Biosimilars pathway
• SOCMA concerns
Future joint API inspections likely
EMA concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. More...
 
Pfizer's $50-million drug discovery partnership
Pfizer has partnered with the University of California’s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. More...
 
No "one size fits all" for biosimilars
FDA scientists have published an article describing their current thinking about a pathway for the US regulatory approval of biosimilars, which reflects examination of EMA guidelines, as well as the nature of biological drugs. More...
 
SOCMA comments on chemical data reporting rule
The Society for Chemical Manufacturers & Affiliates (SOCMA) has commented on modifications to the Inventory Update Reporting rule, also broadly known as the Chemical Data Reporting rule. The final rule was issued earlier this month. More...
 
Join our community on LinkedIn
Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...
 

Latest blog posts
Reinventing a national manufacturing strategy
FDA follows EMA toward follow on biologics
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Emerging markets
The challenges of the emerging markets
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Making a mark in the emerging markets
More latest articles

Upcoming events
Biobanking Global Summit (6–7 September | UK)
European Chemicals Policy — REACH (7–8 September | Spain)
Pharma eMarketing Congress 2011 (13–14 September | Portugal)
More events

Product/Service Profiles
Oxoid

QC Organisms for performance qualification of culture media
Quanti-Cult Plus™ quality control micro-organisms are ideal for use in pharmaceutical applications such as growth promotion testing and method validation. They are convenient to use with each aliquot guaranteed to deliver <100 CFU and only 3 passages from the ATCC® strain. Once reconstituted they are stable for up to 8 hours at 2-8C.
Read more
 
Lonza

Lonza Continuous Flow Microreactors. Our latest microreactor technology is designed to ensure complete scalability from small flow rates to large throughput, enabling consistent scale-up from a few grams to several tons of product.
Read more

 
Sterilin

High quality pharmaceutical packaging products
Sterilin high quality plastic packaging products are ideal for storing and transporting a wide range of pharmaceutical products. Read more
 
3M Purification

The Zeta Plus Encapsulated Filter System from diversified technology company 3M is a disposable depth filtration system for cell culture clarification or downstream impurity removal. Read more

Live Webcast

Preventing Costly Out-of-Specification Investigations
Tues, 20 Sept 2011, 11:00 EST, 4:00 PM BST
Join Dr. Charles Ray, former Associate Director of Analytical R&D at Bristol-Myers Squibb Co. and he will show you how to tackle 50% of the errors that cause Out-of-Specification results by streamlining sample/standards preparation.More information…

Event profiles

Extractables & Leachables for Pharmaceutical Products
27-28 September 2011
Dublin, Ireland
Extractables and leachables assessment of all materials - especially from elastomeric and plastic components - forms an integral part of the submission for approval of a new drug system or medical device.Read more

 

Impurities
14-15 September 2011
Angelo Hotel Prague
Prague, Czech Republic
Developing strategies for detecting, identifying and controlling impurities whilst ensuring regulatory compliance.
Don't miss this opportunity to hear from an MHRA representative, plus gain practical advice for detecting, identifying and quantifying impurities with important case studies from senior industry speakers. Read more

 
Survey
Does the increasing demand for highly potent APIs justify the high costs associated with upgrading manufacturing containment systems?
■ Yes 70%
 
■ No 30%

This week we would like to know...

As it creates a plan to implement the US biosimilar pathway, should FDA borrow from EMA's pathway?

Click here to vote

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