Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol
…, R Swift, MVS Wadhwa, F Jameel, S Patro… - PDA Journal of …, 2007 - journal.pda.org
The process of freeze-thaw not only subjects bioproducts to potentially destabilizing stress,
but also imposes challenges to retain container integrity. Shipment and storage of frozen …
but also imposes challenges to retain container integrity. Shipment and storage of frozen …
Mechanistic studies of glass vial breakage for frozen formulations. II. Vial breakage caused by amorphous protein formulations
…, R Swift, MVS Wadhwa, F Jameel, S Patro… - PDA Journal of …, 2007 - journal.pda.org
In an accompanying article we have described parameters that influence vial breakage in
freeze-thaw operations when using crystalizable mannitol formulations, and further provided a …
freeze-thaw operations when using crystalizable mannitol formulations, and further provided a …
Applications of statistical regression and modeling in fill–finish process development of structurally related proteins
G Jiang, A Thummala, MVS Wadhwa - Journal of pharmaceutical sciences, 2011 - Elsevier
In order to increase efficiency and reduce cost, many biotechnology and pharmaceutical
companies utilize platform approaches for discovery and development of structurally related …
companies utilize platform approaches for discovery and development of structurally related …
Non-specific binding and saturation of Polysorbate-20 with aseptic filter membranes for drug substance and drug product during mAb production
…, N Bingham, H Yeung, B Dransart, MV Wadhwa… - Journal of Membrane …, 2008 - Elsevier
An issue identified during filtration of mAb drug substance is Polysorbate-20 absorption by
polyethersulfone filter membranes. Experiments determined that both polyvinylidene fluoride …
polyethersulfone filter membranes. Experiments determined that both polyvinylidene fluoride …
[BOOK][B] Redundant Filtration Sizing and Scale Up in Sterile Filtration Applications
PS Bhinder, W Ji, HG Sparks, MV Wadhwa, S Patro… - 2005 - aiche.confex.com
Filtration is commonly used for sterilization of protein therapeutics in the biopharmaceutical
industry. Recent guidance provided by the FDA for aseptic processing of sterile drug …
industry. Recent guidance provided by the FDA for aseptic processing of sterile drug …
[DOC][DOC] BIOT 1 Investigation of the use of FACS in cell line development
D Krishna, A Taylor - ABSTRACTS OF PAPERS OF THE …, 2008 - userpages.umbc.edu
The economic production of monoclonal antibodies in mammalian cell lines is dependent
upon the selection of high producing cell lines. This process is extremely time, labor and cost …
upon the selection of high producing cell lines. This process is extremely time, labor and cost …
[CITATION][C] BIOT 177-Investigation into concentration gradient formation in high concentration antibody formulations
…, A Thummala, MV Wadhwa - ABSTRACTS …, 2008 - … CHEMICAL SOC 1155 16TH ST, NW …