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A Rapid Low-Risk Approach For Process Transfer Of Biologics From Development To Manufacturing Scale

This paper explores one approach for overcoming several scale-up issues with the use miniature bioreactors for process development. ....

Jens Christoph Matuszczyk , Melisa Carpio , Sebastian Ruhl , Jens Rupprecht , Gerhard Greller , Naomi De Almeida ,

Intensified Seed Train Strategy For Faster Cost-Effective Scale-Up Of Biologics Manufacturing


By Jens-Christoph Matuszczyk, Johannes Lemke, Markus Schulze, Sabrina Janoschek, Gerben Zijlstra, and Gerhard Greller
The high costs of and limits on global accessibility of biologics such as monoclonal antibodies (MAbs) are focusing the biopharmaceutical industry’s attention on strategies for rapid, economical development of such therapies. Process intensification is one approach to help shorten manufacturing timelines and reduce cost of goods (CoG) (1, 2). Today, process intensification in upstream cell culture enables biologics manufacturing in facilities with smaller footprints and lower scale-up volumes than was possible before. Intensified processing of Chinese hamster ovary (CHO) clones that produce MAbs is being developed in the seed train of upstream cell cultures (3) to support generation of high–cell-density (HCD) cell banks and processes to reduce plant size, capital investment, and overhead costs while increasing productivity. ....

Jens Christoph Matuszczyk , Gerben Zijlstra , Markus Schulze , Johannes Lemke , Gerhard Greller , Sabrina Janoschek , Cell Research , செல் ஆராய்ச்சி ,

03.09.21 -- Incorporating Excipients Into QbD Studies For Drug Development -- An Introduction


03.09.21 Incorporating Excipients Into QbD Studies For Drug Development An Introduction
 
 
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
 
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
 
 
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), and Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide, “Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design,” published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the ....

Jens Christoph Matuszczyk , Pim Hermans , Elina Klijs , Alex Armengol , Kevin Sleijpen , James Faust , Anja Overweel , Melisa Carpio , Robert Smith , Gerhard Greller , Frank Detmers , Janice Abel , Brian Rodenhausen , Sebastian Ruhl , Andy Goll , Jens Rupprecht , Hendrik Adams , Matt Hicks , Maria Lloris , Bernat Busquet , Paul Janszen , John Erdner , Simon Adema , Frederic Baudry , Seeq Corporation , Article Stevanato Group ,