2022 PDA Pharmaceutical Microbiology Conference

10-12 October 2022

Vineeta A. Pradhan, PhD

U.S. FDA

Vineeta Pradhan joined the Food and Drug Administration (FDA) in 2016 and is currently working as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). She reviews the pre- and post-approval CMC information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.

Prior to joining the FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.

Vineeta received her Ph.D. in Microbiology from The Ohio State University.

Frederic B. Ayers

Eli Lilly and Company

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Bachelor of Arts (B.A.) in Biology. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site's sterility assurance programs. Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.
Dan Bice

Adaptimmune

Daniel Bice is an Assoicate Director for Quality Control Operations at Adaptimmune LLC, focusing on release of all drug products, validation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs. Dan has 10 years of microbiology experience in the pharmaceutical industry. He has been an active PDA member since 2017. Dan earned his B.S. in Life Sciences from The Pennsylvania State University.
Lori Daane, PhD

bioMerieux, Inc

Lori Daane is the Sr. Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative microbiological methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on phytoremediation of polyaromatic hydrocarbons and at the Los Alamos National Laboratory studying microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
Lynne A. Ensor, PhD

PAREXEL International

Dr. Lynne Ensor is a Senior Vice President and the Head of RCS Global Compliance for Parexel International. She has been a consultant to the biopharmaceutical industry since 2019. Her areas of expertise include sterile product manufacturing and testing, pharmaceutical microbiology, manufacturing facility compliance, and regulatory strategy. Prior to consulting, Lynne was employed by the U.S. Food and Drug Administration (FDA) for 21 years. While at FDA, she served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/CDER. Her responsibilities included oversight for new, generic, biologic, and biosimilar drug product quality (CMC) review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Sciences’ New and Generic Drug Product Quality Microbiology staff, and Director of Office of Generic Drugs’ Division of Microbiology. Lynne’s previous experience includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.
Kurt Jaecques, MA

GSK Vaccines

Kurt Jaecques is Global Aseptic Technologies lead for Monitoring and Control at GSK Vaccines and had been working within the pharmaceutical Industry for more than 28 years now. He holds a Master degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring and clean Utilities in particular. He recently co-chaired the update of the PDA TR13 on Environmental Monitoring.
Simleen Kaur, MSc

U.S. FDA

CAPT Simleen Kaur has a Masters in Biotechnology from Johns Hopkins University and Bachelors in Biology from the University of Delhi (India). She is currently stationed in Food and Drug Administration, under Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. She serves as a Team Leader for Laboratory of Microbiology In-vivo Testing and Standards where she reviews microbiological test methods used in the release of biological products as submitted in Biological License Applications and Supplements to ensure they are validated in accordance with Code of Federal Regulations and different pharmacopeia requirements. In addition, she manages production and distribution of CBER Reference materials used in potency testing of biological products such as vaccines prior to release to public.
Christine Sherman, BA

Takeda

Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing at the sterile manufacturing sites. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, cell therapies, and vaccines. Prior to joining Takeda in 2017, she worked for pharmaceutical companies including Johnson & Johnson and Pfizer in the QC microbiology laboratory, and later, at Merck in a Sterility Assurance role for the vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental and utility monitoring, programs, process simulation of bulk and finished product, and smoke studies, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. She has experience supporting Microbiological investigations for environmental and utility monitoring, sterile and non-sterile products, and process simulation positives. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently a member of the USP Expert Microbiology Committee.
Lydia Troutman

Merck & Co., Inc.

Develops and implement healthcare compliance program policies, guidelines,, procedures and training initiatives. Provide healthcare compliance communications, guidance and interpretation to commercial, medical affairs, and research and development departments.

30+ years of progressive experience in sterile and non-sterile pharmaceutical industry with extensive focus on Quality Assurance and Compliance at international level.

Member of PDA; Participating Author for PDA Technical Bulletin #13, Fundamentals of Microbiological Monitoring Program; Member of (PMED) Professional Microbiology, Education, and Discussion Group; Member of (HBA) Healthcare Business Women’s Association; Member of (WOCIP) Women of Color in Pharma.
MaryEllen E. Usarzewicz, MS

Bristol-Myers Squibb

MaryEllen E. Usarzewicz received her M.S. in Microbiology from Wagner College in 2000 . After several years working in CRO’s, she joined BMS in 2007, initially in the analytical space providing microbiological support to the clinical supply operations and has recently transitioned to the cell therapy organization in BMS, where she is the Director of QC Microbiology. She is active in several teams in the Parenteral Drug Association and in her spare time she is busy raising two children.
Friedrich von Wintzingerode, PhD

Genentech, Inc.

Friedrich is QC Lead of the iNeST (individualized Neoantigen Specific Therapy) program at Roche-Genentech.

Friedrich joined Roche-Genentech after earning his PhD in Microbiology and has over 20 years of experience in Quality Control and Quality Assurance in the biopharmaceutical industry, working on various topics including microbiological testing, material specifications, environmental monitoring, cleaning analytics, and analytics for release.

Friedrich has led several global technical teams (e.g. microbial identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) at Roche-Genentech. He co-chaired the PDA Low Endotoxin Recovery Task Force, which authored PDA Technical Report No 82 on LER. He is also a member of the PDA ATMP advisory board.
Jason L. Willett

Veltek Associates, Inc.

Jason Willett is currently the Midwest Manager for Veltek Associates Inc., providing contamination control products and services to the pharmaceutical, biotech, and healthcare industries. In this position, Jason regularly consults with pharmaceutical manufacturers in the areas of cleaning, disinfection, aseptic practices, environmental monitoring and regulatory expectations. With over 20 years of relevant experience, Jason is able to help customers develop compliant and cost effective contamination control programs. In addition to his responsibilities at Veltek, Jason is a volunteer on the PDA’s Exhibit Committee and Treasurer for the PDA Midwest Chapter.

Jason graduated from the University of Cincinnati with a bachelor’s degree in Chemistry and lives near Cincinnati, OH with his wife, Leslie, and three children, Ella, Laney and Matthew.

Ziva Abraham, PhD

Microrite, Inc.

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel.

She uses her extensive clinical microbiology experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
Frederic B. Ayers

Eli Lilly and Company

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Bachelor of Arts (B.A.) in Biology. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site's sterility assurance programs. Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.
Yemi Babatola, MS

Amgen Inc.

Yemi Babatola is a Principal Engineer in Amgen, Process Development, with several year experience in aseptic manufacturing, technology transfer, device and primary container development, and method development. He has led a number of projects to introduce next generation aseptic technologies into the manufacturing network, including isolator technologies and enzyme indicators. Currently, as part of Process Development, he leads a team of engineers and scientists responsible for tech transfer and new product introductions into Amgen commercial drug product manufacturing sites. Yemi holds a BS in Mechanical Engineering from Illinois Institute of Technology and a MS in Mechanical Engineering from Carnegie Mellon University.
Rafael Beaus

Azbil Telstar Technologies SL

Bachelor on Pharmacy from the University of Barcelona (1988), PDG (General Management Program, 2002) from IESE (Barcelona), and Industrial and Pharmacy Technology specialist (2001). Appointed as member of the Royal Catalan Academy of Pharmacy from 2016. More than 30 years of industry experience: 10 years at AlconCusi Laboratories as Manager of the factory for solid and liquid forms (3 years) and then promoted to Head of Quality Assurance and Technical Director. From 1998, he began his consultancy activity as MD of SVS, internationalizing the company and making it grow until its integration into the Telstar group, where he has been employed in different roles, always in local and outside markets. Currently working at Azbil Telstar as Global Consultancy Manager. Author of several technical articles and books & lecturer at many specialized courses worldwide, about sterile production, pharmaceutical utilities, plant design, quality assurance, inspections preparation and general production. He has also been a trainer on several occasions for the Spanish Medicine Agency.
Martin Blaser, MD

Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University

Martin J. Blaser holds the Henry Rutgers Chair of the Human Microbiome at Rutgers University, and serves as Director of the Center for Advanced Biotechnology and Medicine. Previously, he served as Chair of the Department of Medicine at New York University. A physician and microbiologist, Dr. Blaser has been studying the relationships we have with the human microbiome, the bacteria that live in us. Over the last 20 years, he has also been actively studying the relationship of the human microbiome with both health and important diseases including asthma, obesity, diabetes, and cancer. Dr. Blaser has been the advisor to many students, post-doctoral fellows, and faculty. He has served as President of the Infectious Diseases Society of America, Chair of the Board of Scientific Counselors of the National Cancer Institute, and Chair of the Advisory Board for Clinical Research of the NIH. He currently serves as Chair of the Presidential Advisory Council for Combatting Antibiotic Resistant Bacteria (PACCARB). He was elected to the National Academy of Medicine and the American Academy for Arts and Sciences. He has authored over 600 original scientific articles, holds 24 U.S. patents, and he also wrote Missing Microbes, a book targeted to general audiences.
Renée S. Blosser, MS

U.S. FDA

Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.
Angie L. Bragdon, MS

Eli Lilly and Company

Angie Bragdon is a Senior Principal Scientist at Lilly's Indianapolis Parenteral Manufacturing site. Within the Technical Services organization, she serves as a Sterility Assurance Subject Matter Expert that provides contamination control technical stewardship. Angie's background in microbiology includes supporting sterile and non-sterile manufacturing facilities representing various production platforms and technologies. Additionally, she is experienced leading highly complex microbiological investigations.

Angie received her M.S. in Biomedical Sciences from Auburn University College of Veterinary Medicine in 2001 and B.S. in Laboratory Technology from Auburn University College of Science and Mathematics in 1999. Before joining Lilly in 2012, she held positions in academic research, pharmaceutical product development and micro quality control labs.
Ellen Brunbech, MSc

Novo Nordisk A/S

Ellen Brunbech graduated year 2000 from the University of Copenhagen with a master degree in biology. Since 2001 Ellen Brunbech has worked in the field of microbiological quality control of pharmaceuticals for Novo Nordisk A/S, a global healthcare company with headquarters in Denmark. Through her more than 20 years of work in the pharmaceutical industry she has gained an in depth understanding of testing methodology, analytical requirements and current Good Manufacturing Practices in the field of pharmaceutical microbiology.
Erica Carpenter, MBA, PhD

University of Pennsylvania School of Medicine

Erica L. Carpenter, MBA, PhD, is the director of the Liquid Biopsy Laboratory and a Research Assistant Professor in the Department of Medicine, Division of Hematology/Oncology at the University of Pennsylvania.

She completed her doctoral studies in the Biomedical Graduate Studies immunology program at the University of Pennsylvania School of Medicine. She subsequently completed post-doctoral training in the field of cancer genetics at the Oncology Division of the Children’s Hospital of Philadelphia.

Prior to joining Penn, Dr. Carpenter obtained a Masters in Business Administration at the Tuck School at Dartmouth College, and worked as a business executive for a Fortune 50 manufacturer. Over the course of her business career, she had profit and loss responsibility for divisions with >$2 billion revenue, and participated in the management of both domestic and overseas business units.

Dr. Carpenter’s NCI-funded research programs focus on the identification, capture, and analysis of circulating tumor cells, exosomes, and cell-free circulating tumor DNA from cancer patients. The overarching goal is to utilize molecular profiling of circulating tumor material to improve the delivery of precision medicine by informing individualized treatment decisions, and targeting the most aggressive cancer cells. For our patients, this means better care and less discomfort.
Harolyn M. Clow, MS, SM (NRM)

Teva Pharmaceuticals

Harolyn Clow has over 35 years of industry experience in pharmaceutical microbiology in manufacturing, biotech and contract laboratory operations. Ms. Clow is currently a Manager of Quality Control Microbiology at Teva Pharmaceuticals in West Chester, PA. She is a subject matter expert in disinfectant efficacy studies and environmental monitoring programs. Ms. Clow holds a Bachelors of Science degree in Microbiology from Colorado State University and a Masters of Science in Quality Assurance and Regulatory Affairs from Temple University.
Lori Daane, PhD

bioMerieux, Inc

Lori Daane is the Sr. Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative microbiological methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on phytoremediation of polyaromatic hydrocarbons and at the Los Alamos National Laboratory studying microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
Gilberto Dalmaso, PhD

Veltek Associates Inc.

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings.

In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Technical Science Director Europe & Asia for Veltek Associates Inc.

In this role, he collaborates with pharmaceutical companies and authorities to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, and methods.
CDR Donald Ertel, MS, MT(ASCP)

U.S. FDA

Commander Donald Ertel received his B.S. Degree in Medical Technology from the University of Maryland and a master’s degree in Regulatory Affairs / Quality Assurance from Temple University School of Pharmacy. CDR Ertel currently serves in the role of Team Lead for DMPQ. For over 12 years, CDR Ertel’s primary duty has been scientific review (CMC) of BLAs and PMAs. As a CBER lead inspector, he performs, and trains new inspectors in, pre-license/approval inspections for BLAs and supplements; and has performed numerous facility inspections, domestically and internationally. CDR Ertel has over 30 years of experience working in quality assurance and compliance in and with regulated industries of blood banking & cell therapy (prior employment at Johns Hopkins Hospital), biotechnology, and pharmaceuticals (prior employment at Shire Pharmaceuticals). As an USPHS officer, CDR Ertel has participated in multiple deployments in support national crisis including twice to the COVID-19 global response.
Irving Ford, MSc

Adaptimmune

Irving Ford is currently the VP of Quality at Adaptimmune.

Irving has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.

Irving is an active member of PDA and has served on several planning committees for various PDA Conferences. Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies. Irving is currently co-authoring a PDA ATMP Points to Consider document for ATMPs.
Maria Gajewi

Microcoat Biotechnologie GmbH

My name is Maria Gajewi and I am Group Leader in the Endotoxin Services at Microcoat Biotechnologie GmbH.

I studied chemistry, focused on biochemistry and then got into endotoxins and pyrogens. Now I am taking care of BET, as well as MAT projects for development of special sample treatments (e.g. demasking of endotoxin or measurement of samples in the MAT), especially in the stage of method validation and release testing. If you have a product that is not easily measurable in the BET or shows an LER effect, we are the right to call.
Gurpreet Ganda, MS

Roche

Gurpreet Ganda, Senior Manager at Roche for 10 yrs and has experience of working with multiple pharmaceutical/biotechonology companies. I have Masters in Microbiology and has extensive experience with setting up qualification program for new facilities, leaning, applying risk assessment tools, setting up routine Environmental monitoring program for facilities and presenting to health authorities. The experience span to Drug substance, Drug product, Small molecules, new modalities, clinical and commercial facilties. I also have extensive experience with aspectic processing, qualification and validation of equipments.

I head the Roche network team of Environmental monitoring team and responsible for implementing any changes/addressing challenges and providing overall network support. I have presented previously two times for UPW seminars on the topic of Pharmaceutical Water. I am also a member of BPOG team that covers the EM part.
Tamara Garcia-armisen, PhD

GSK

Tamara Garcia-Armisen is a senior scientist currently in charge of the Sterility Assurance and contamination control strategy for aseptic manufacturing of viral vaccines bulk (Biologicals) at GSK. She holds a Master in Microbiology and Molecular biology and a PhD in Microbiology from the ULB (Free University of Brussels). Tamara has over 20 year of academic and industrial experience in Microbiology and Quality Assurance. Previous roles included microbiology and sterility assurance expert for QC and QA in plasma-derivate products manufacturing; Research Scientist in Sterility assurance for medical devices in charge of development and Validation of sterilization and disinfection strategies and Academic researcher authoring more than 20 papers in peer reviewed journals in Environmental Microbiology and water contamination topics. This experience across different fields, different products and lifecycle steps and different companies allow her to have a complete vision of the main challenges of the industry for the next years in the Contamination control and sterility assurance topics.
Marc Glogovsky, MS, SM (NRCM)

Valsource, Inc.

Marc Glogovsky is the Microbiology Business Unit Manager and Senior Microbiology Consultant with ValSource, Inc., focusing on development and improvement of contamination control strategies, validation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

Marc has more than 20 years of microbiology experience in the pharmaceutical industry. He has been an active PDA member since 2000, is currently serving on PDA’s Science Advisory Board, where he is also the Interest Group Liaison, and is a member of both the ATMP Advisory and Education Advisory Boards. He is the North American chair of the Microbiology/EM Interest Group, has served on numerous Technical Report committees, and has co-chaired the Microbial Data Deviation Investigations and Environmental Monitoring Technical Reports and the ATMP Microbiology Points to Consider report.

Marc was a founding member of the PDA Mycoplasma task force and is an active advisor to the PDA Environmental Monitoring Task Force. In 2020, Marc received the James P. Agalloco award for his efforts at PDA’s Training and Research Institute (TRI), where he has been a faculty member teaching EM courses, for more than 10 years.

Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.
Ruben A. Grosso, PhD

University of Southern Denmark

My name is Ruben Adrian Grosso, and I was born in Argentina. During my veterinary degree I started my research career as fellow at the Clinical Microbiology lab focusing on Escherichia coli O157:H7 epidemiology and surveillance of antimicrobial resistance in animal-infecting microbes. Afterwards, I completed my Ph. D. in Biological Sciences studying the molecular mechanisms involved in erythroid cells maturation and its relationship with erythroid leukemia disease. In 2019, I moved to Sweden for my first postdoc at the Clinical Immunology Department of Uppsala University where I focus on unraveling the role of lymph node endothelium in modulating the anti-tumoral and anti-inflammatory immune response. I have been always passionate about Public Health, and since beginning of 2021, I´ve been working as postdoc in a collaborative effort between the University of Southern Denmark and Novo Nordisk company. This project aims to detect microbial contamination in drug products using novel Raman spectroscopy methods.
Rajesh K. Gupta, PhD

Biologics Quality & Regulatory Consultants, LLC

Rajesh K. Gupta has a Ph.D. in microbiology and is President and Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 40 years’ experience in the pharmaceutical microbiology, specifically in the development, production, testing, and regulation of vaccines and other biological products, working at both the regulatory agencies and the industry. At FDA, CBER, he formed the Division of Biological Standards and Quality Control and was a Deputy Director and Lab Chief in that Division, managing lot release of biological products, review of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH) in the US and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development/validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and made numerous presentations at scientific and regulatory meetings.