Scientists / Our Scientists

Miguel Saggu

Technical Development Staff Scientist, Pharmaceutical Development, Technical Development

Postdoc Mentor

10

Years at Genentech

16

Publications at Genentech

1

Awards & Honors

I started at Genentech in 2014 after receiving my PhD in physical chemistry in 2009 from TU Berlin and working as a postdoc at Stanford University. Since then, I’ve been working in Pharmaceutical Development with a focus on applying spectroscopic and imaging techniques to characterize particles and analyze materials.

Postdoctoral Mentor

My lab is collaborating with many different functions at Genentech and people in the lab get exposed to different aspects of the business process. Being a postdoc mentor represents a great opportunity to train the next generation of scientists. In particular, postdocs can focus on applying scientific principles to solve complex analytical problems.

Featured Publication

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products.

J Pharm Sci. 2024 May;113(5):1401-1414.

Miguel Saggu, George M Bou-Assaf, Reinhard Bucher, Ivan L Budyak, Jakob Buecheler, Shawn Cao, Minna Groenning, Emon Khan, Stanley C Kwok, Shalini Minocha , Karthik Pisupati, Vinay Radhakrishnan, Nicoline Videbæk, Dennis T Yang, Bin Zhang, Linda O Narhi.

Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway.

Pharm Res. 2015 Sep;32(9):2877-88.

Miguel Saggu, Jun Liu, Ankit Patel.

At Genentech I’m leading a biophysical spectroscopy and imaging lab focusing on particle characterization. In addition, I’m heavily involved in industry consortia to advance technology development and characterization strategies.

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

Journal of Pharmaceutical Sciences, ISSN: 00223549

Miguel Saggu; George M. Bou-Assaf; Reinhard Bucher; Ivan L. Budyak; Jakob Buecheler; Shawn Cao; Minna Groenning; Emon Khan; Stanley C. Kwok; Shalini Minocha; Karthik Pisupati; Vinay Radhakrishnan; Nicoline Videbæk; Dennis T. Yang; Bin Zhang; Linda O. Narhi

A Novel Technique to Assess Drug Substance Particle Size in a Complex Inhaled Formulation

Journal of Pharmaceutical Sciences, ISSN: 00223549

Daniel P. Dobson; Miguel Saggu; Jackson D. Pellett; Jerry Tso

Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody

Journal of Pharmaceutical Sciences, ISSN: 00223549

Karthik Balakrishna Chandrababu; Aadithya Kannan; John R. Savage; Samantha Stadmiller; Adam E. Ryle; Chloe Cheung; Robert F. Kelley; Maa; Miguel Saggu; Deborah L. Bitterfield

Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection—Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

Journal of Pharmaceutical Sciences, ISSN: 00223549

Maryam Mazaheri; Miguel Saggu; Klaus Wuchner; Atanas Koulov; Felix Nikels; Pascal Chalus; Tapan K. Das; Patricia W. Cash; Christof Finkler; Sophia Levitskaya-Seaman; John Case; Jonny Parsons; Kristen Gonzalez

Probing the Protein-Excipient Interaction in the Orally Delivered Protein by Solid-State Hydrogen-Deuterium Exchange Mass Spectrometry and Molecular Dynamics

Analytical Chemistry, ISSN: 00032700

Xiao Pan; Sunidhi Lenka; Jeff Davis; Karthik Nagapudi; Priscilla Mantik; Miguel Saggu; Lulu Dai; Lance Cadang; Hui-Min Zhang; Jennifer Zhang; Saeed Izadi; Feng Yang; Bingchuan Wei

An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards

AAPS PharmSciTech, ISSN: 15309932

Srivalli N. Telikepalli; Michael J. Carrier; Dean C. Ripple; Greg Barnett; Ashwinkumar Bhirde; Donna Bolton; George M. Bou-Assaf; Erica Ferrari; Scott Leigh; Sophia Levitskaya-Seaman; Tim Menzen; Felix Nikels; Anna Riley; Miguel Saggu; Neha Sahni; Eric Vernooij; Klaus Wuchner

A Mechanistic Understanding of Monoclonal Antibody Interfacial Protection by Hydrolytically Degraded Polysorbate 20 and 80 under IV Bag Conditions

Pharmaceutical Research, ISSN: 1573904X 07248741

Aadithya Kannan; Jamie Giddings; Shrenik Mehta; Tiffany Lin; Anthony Tomlinson; Kyle Ritchie; Ian C. Shieh; Miguel Saggu; Nidhi Doshi

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Kurt D. Benkstein; Gurusamy Balakrishnan; Ashwinkumar Bhirde; Pascal Chalus; Tapan K. Das; Ngoc Do; David L. Duewer; Nazar Filonov; Fook Chiong Cheong; Patrick Garidel; Nicole S. Gill; Adam D. Grabarek; David G. Grier; Judith Hadley; Andrew D. Hollingsworth; Wesley W. Howard; Maciej Jarzębski; Wim Jiskoot; Sambit Kar; Vikram Kestens; Harshit Khasa; Yoen Joo Kim; Atanas Koulov; Anja Matter; Laura A. Philips; Christine Probst; Yannic Ramaye; Theodore W. Randolph; Dean C. Ripple; Stefan Romeijn; Miguel Saggu; Franziska Schleinzer; Jared R. Snell; Jan “Kuba” Tatarkiewicz; Heather Anne Wright; Dennis T. Yang

Evaluating a Modified High Purity Polysorbate 20 Designed to Reduce the Risk of Free Fatty Acid Particle Formation

Pharmaceutical Research, ISSN: 1573904X 07248741

Nidhi Doshi; Kyle Ritchie; Tamanna Shobha; Jamie Giddings; Kathrin Gregoritza; Rosalynn Taing; Stephen Rumbelow; Jeff Chu; Anthony Tomlinson; Aadithya Kannan; Miguel Saggu; Si Kai Cai; Victor Nicoulin; Wenqiang Liu; Steve Russell; Lin M. Luis; Sandeep Yadav

Extended Characterization and Impact of Visible Fatty Acid Particles - A Case Study With a mAb Product

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Miguel Saggu; Barthélemy Demeule; Linda Jiang; Daniel Kammerer; Purnendu K. Nayak; Michelle Tai; Nina Xiao; Anthony Tomlinson

Analysis of Aggregates and Particles

AAPS Advances in the Pharmaceutical Sciences Series, ISSN: 2210738X 22107371

Yuan Cheng; Miguel Saggu; Justin C. Thomas

Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins

PDA Journal of Pharmaceutical Science and Technology, ISSN: 19482124

Wen-Li Chung; Jian Yin; Steven Messick; Miguel Saggu; Kate Tschudi; Ann Marie Woys; Rod Rahimi; Marianne Azarias; Connie Kong; Bruce Kabakoff

Chapter 11: Particles in Biopharmaceuticals: Causes, Characterization, and Strategy

AAPS Advances in the Pharmaceutical Sciences Series, ISSN: 2210738X 22107371

Steven Messick; Miguel Saggu; Anacelia Ríos Quiroz

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Mario Hubert; Dennis T. Yang; Stanley C. Kwok; Anacelia Rios; Tapan K. Das; Ankit Patel; Klaus Wuchner; Valentyn Antochshuk; Friederike Junge; George M. Bou-Assaf; Shawn Cao; Miguel Saggu; Luis Montrond; Nataliya Afonina; Parag Kolhe; Vakhtang Loladze; Linda O. Narhi

A Random Forest Approach for Counting Silicone Oil Droplets and Protein Particles in Antibody Formulations Using Flow Microscopy

Pharmaceutical Research, ISSN: 1573904X 07248741

Miguel Saggu; Ankit Patel; Theodoro Koulis

Identification of Subvisible Particles in Biopharmaceutical Formulations Using Raman Spectroscopy Provides Insight into Polysorbate 20 Degradation Pathway

Pharmaceutical Research, ISSN: 1573904X 07248741

Miguel Saggu; Jun Liu; Ankit Patel

TU Berlin, PhD in Physical Chemistry – 2009
TU Berlin, Diploma in Physical Chemistry – 2006

DFG Postdoctoral Fellowship Award – 2010