Pharmaceutical Technology Europe - June 2012 - (Page 7)

BLOGS ABRIDGED AAPS Biotech held its annual meeting this year in San Diego, CA, the city with arguably the best weather in the world! Sessions opened with a symposium on the challenges associated with high concentration protein formulations. Dr Vinay Radhakrishnan of Pfizer began with an overview of high concentration protein formulation, showing that the concentrations required of monoclonal antibody therapies have increased from a few mg/mL for the first approved therapies, to more than 100 mg/mL for therapies now entering the field. The increase is driven sometimes by therapeutic necessity, and sometimes by the desire to simplify dosing. Whatever the reason, to produce such high concentration protein formulations requires overcoming problems of aggregation and viscosity. Dr. James Colandene of HGS presented a case study of high variability in a fill line caused by the high viscosity of the product and clogging of the fill needles if a pause occurred in the fill line. http://blog.pharmtech.com/2012/05/22/live-from-aaps-biotech/ Greetings from AAPS Biotech ICH Q11 Reaches Harmonisation ICH Q11, the anticipated guideline from the International Conference on Harmonisation (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonisation process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organisations in the US, Europe and Japan have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies will publish the guideline as official guidance within their appropriate regions and implementation will begin. The Q11 guideline will be folded into the Quality trio, which includes ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. http://blog.pharmtech.com/2012/05/15/ich-q11-reaches-harmonizationimplementation-is-next/ 2 Analytical Stability 11 Freeze Drying Optimisation 3 Aseptic Filling 12 Hot Melt Extrusion 4 News 14 Interview 10 Manufacturing 16 Ask the Expert http://blog.pharmtech.com/2012/05/22/live-from-aaps-biotech/ http://blog.pharmtech.com/2012/05/15/ich-q11-reaches-harmonization-implementation-is-next/ http://blog.pharmtech.com/2012/05/15/ich-q11-reaches-harmonization-implementation-is-next/

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - June 2012

Pharmaceutical Technology Europe - June 2012
Contents
Analytical Stability
Aseptic Filling
News
Blogs Abridged
Cleaning
Manufacturing
Freeze Drying Optimisation
Hot Melt Extrusion
Column Crunch: Biomanufacturing; European Regulators Struggle
Interview
Ask the Expert

Pharmaceutical Technology Europe - June 2012