The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|August 8, 2013
Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme for Niemann Pick Type B Disease
Author(s)Pharmaceutical Technology Editors
Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.
Advertisement
The firm, based in St. Louis, Missouri, was established in 2010 and acquired a commercial biopharmaceutical manufacturing facility from Johnson & Johnson, Centocor division in 2011. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally.
Source:
Advertisement
Related to this article
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Advertisement
Advertisement