Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces
Mehta, Shyam B., Carpenter, John F., Randolph, Theodore W.
Published in Journal of pharmaceutical sciences (01.08.2016)
Published in Journal of pharmaceutical sciences (01.08.2016)
Get full text
Journal Article
Gelation of a Monoclonal Antibody at the Silicone Oil–Water Interface and Subsequent Rupture of the Interfacial Gel Results in Aggregation and Particle Formation
Mehta, Shyam B., Lewus, Rachael, Bee, Jared S., Randolph, Theodore W., Carpenter, John F.
Published in Journal of pharmaceutical sciences (01.04.2015)
Published in Journal of pharmaceutical sciences (01.04.2015)
Get full text
Journal Article
Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach
Mehta, Shyam B., Cook, Joseph, Liu, Wei, Brisbane, Charlene
Published in Journal of pharmaceutical sciences (01.07.2022)
Published in Journal of pharmaceutical sciences (01.07.2022)
Get full text
Journal Article
Effect of protein cryoconcentration and processing conditions on kinetics of dimer formation for a monoclonal antibody: A case study on bioprocessing
Mehta, Shyam B., Subramanian, Srishty, D'Mello, Rowena, Brisbane, Charlene, Roy, Shouvik
Published in Biotechnology progress (01.07.2019)
Published in Biotechnology progress (01.07.2019)
Get full text
Journal Article
Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products
Blümel, Markus, Liu, Jing, de Jong, Isabella, Weiser, Sarah, Fast, Jonas, Litowski, Jennifer, Shuman, Melissa, Mehta, Shyam B., Amery, Leanne, Tan, David Cheng Thiam, Jia, Feng, Shekhawat, Dushyant, Dagallier, Camille, Emamzadeh, Mina, Medina, Annette, Santos, Camilla, Gasser, Florian, Urban, Christian
Published in Journal of pharmaceutical sciences (01.09.2023)
Published in Journal of pharmaceutical sciences (01.09.2023)
Get full text
Journal Article
Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations
Mehta, Shyam B, Subramanian, Srishty, Brown, Rebecca, D'Mello, Rowena, Brisbane, Charlene, Roy, Shouvik
Published in PDA journal of pharmaceutical science and technology (01.05.2020)
Published in PDA journal of pharmaceutical science and technology (01.05.2020)
Get more information
Journal Article
Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations
Tchessalov, Serguei, Shalaev, Evgenyi, Bhatnagar, Bakul, Nail, Steven, Alexeenko, Alina, Jameel, Feroz, Srinivasan, Jayasree, Dekner, Michael, Sahni, Ekneet, Schneid, Stefan, Kazarin, Petr, McGarvey, Orla, Van Meervenne, Bert, Kshirsagar, Vaibhav, Pande, Paritosh, Philipp, Jens, Sacha, Greg, Wu, Ke, Azzarella, Joseph, Shivkumar, Gayathri, Bhatt, Shreyas, Mehta, Shyam B.
Published in AAPS PharmSciTech (03.04.2023)
Published in AAPS PharmSciTech (03.04.2023)
Get full text
Journal Article
Partial Unfolding of a Monoclonal Antibody: Role of a Single Domain in Driving Protein Aggregation
Mehta, Shyam B, Bee, Jared S, Randolph, Theodore W, Carpenter, John F
Published in Biochemistry (Easton) (27.05.2014)
Published in Biochemistry (Easton) (27.05.2014)
Get full text
Journal Article
Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Zamiri, Camellia, Leiske, Danielle L, Hughes, Patricia, Kirwan, J Paul, Der, Evelyn, Cox, Emily, Warburton, Rob, Goss, Monica, Weiser, Sarah, Perez-Brown, Janet, Gopalrathnam, Ganapathy, Liu, Jing, Mehta, Shyam B, Shereefa, Shebeer, Specht, Sebastian, Aedo, Sandra J, Goldbach, Pierre, Jia, Feng, Kuehnle, Barbara, Page, Scott, Voeten, Liesbeth, Yi, Li, Zhu, Chen
Published in PDA journal of pharmaceutical science and technology (23.08.2024)
Published in PDA journal of pharmaceutical science and technology (23.08.2024)
Get more information
Journal Article