At iBio, we’re pioneering the next generation of biopharmaceuticals using the System, our proprietary plant-based recombinant protein manufacturing platform.
The speed, safety and scalability inherent in the FastPharming Technology makes it ideal for rapidly advancing promising candidates from concept to clinic, while also enabling “greener” manufacturing. We seek to change the paradigm of drug development by reducing the time, costs, and scale-up issues associated with traditional mammalian cell culture production – thus making plant-based manufacturing the preferred choice for high quality biopharmaceutical development.
The FastPharming System has been successfully used to produce monoclonal antibodies, subunit vaccines, cytokines, and other recombinant proteins. Since we initiated our own proprietary drug development activities in 2020, we used the platform ourselves to scalably manufacture SARS-CoV-2 spike antigen candidates in just five weeks from sequence design – a speed that rivals that of mRNA platform technologies. We subsequently deployed FastPharming to advance a proprietary, second-generation COVID vaccine candidate while also rapidly creating our own pipeline of cancer drug candidates. In fact, we delivered six promising new additions to our oncology portfolio within just six months of establishing our discovery capabilities.
Plus, our novel Glycaneering Development Services℠ provide greater control over the glycosylation of complex biopharmaceuticals. Glycaneering can deliver molecules with greater Antibody-Dependent Cellular Cytotoxicity [ADCC], facilitating the creation of more potent anti-cancer therapeutics. We’ve demonstrated the quality and potency of Glycaneered molecules for our clients, not to mention strong data we’ve generated on plant-made rituximab. We’ve also used Glycaneering to afucosylate our novel anti-CD25 mAb as we convert it from CHO cell production to FastPharming.
We have two facilities; our San Diego, CA, site houses early-stage drug discovery and process development, and our Bryan/College Station, TX, facilty supports bioanalysis, protein characterization, and bioprocess services.
Our experienced team of scientists and engineers helps our clients leverage all of FastPharming’s advantages over mammalian cell culture. We’re experts in plant-based recombinant protein expression and purification process development and are happy to help drug developers avoid expensive media development, risks associated with animal-origin raw materials, master cell bank creation, and other issues associated with mammalian cell culture processes.
FastPharming Advantages
Faster: Greater speed-to-clinic by shaving months off of traditional mammalian-cell development times
Safer: Less contamination risk since mammalian viruses and prions can’t grow in plants
Eco-Friendly: Avoids plastic single-use disposables widely used with mammalian-cell biologics production
Easier: Avoids scaling issues moving to large bioreactors – just grow more plants
Better: Powerful, proprietary glycosylation controls for better performance and higher quality
The FastPharming platform produces a variety of recombinant products including:
Biobetter and biosimilar antibodies
Antigens for subunit vaccine design
Virus-like particles (VLP)
Lysosomal enzymes
Blood factors, including cytokines, growth factors, and interleukins
Commitment to Sustainability
Like many other manufacturing businesses, biopharmaceutical production imposes demands on natural resources and the environment, urging us all to think about the sustainability of future requirements for production and global supply.
In fact, one study states that the drug industry’s emission intensity in 2015 was 55% more than the auto industry1.
We’re pioneering sustainable biomanufacturing with the FastPharming System®. Our upstream raw materials include seeds, purified water/nutrients and photons. Compare that with traditional single-use mammalian cell culture systems that make extensive use of plastic consumables, energy-intensive water (water-for-injection [WFI]), filters, and upwards of 2,000 liter scale bioreactor operations requiring cell culture media consumables, energy to power the mixing, anti-foaming agents, and more.
We offer a more sustainable option for innovators looking to develop their process – an early decision that has a long-term impact. Making the choice today to use our plant-based expression system – delivering a greener, more sustainable process – is a decision that will have a lasting impact for decades as a product moves all the way from concept to commercial production.
1. Belkhir, L., et. al. (2018) “Carbon footprint of the global pharmaceutical industry and relative impact of its major players”. J Cleaner Production 214:185-194
Commitment to Quality Biologics
The Quality Department at iBio is staffed with highly motivated and skilled professionals who are knowledgeable in biologics development and manufacturing. Key elements of our quality program include:
A fully integrated Quality Management System (QMS)
Robust process/product control systems
Comprehensive compliance programs
iBio’s quality systems are designed to comply with cGMP’s as well as ex-US regulatory requirements.
iBio’s Quality Policy
iBio is dedicated to maintaining the effectiveness of the quality system through robust process management and quality oversight, compliance with all applicable regulatory requirements, and meeting or exceeding customer expectations by delivering quality products and services.
Our Team
Tom Isett
Chief Executive Officer & Chairman of the Board
Prior to becoming CEO for iBio in March 2020, Mr. Isett played an integral part in reshaping the Company’s strategy and operations in his role as Board Member and Strategic Advisor since April 2019. He was able to contribute his deep management and strategic insights via the consulting firm he founded in 2015, i.e. Advising, LLC, which supported Fortune 500s, institutional investors, biotechs and non-profits alike with M&A, turnarounds, and more. Previously, he ran business units for GE, Lonza, and BD, ranging in size from start-up to a half billion in revenues. Notably, he founded BD Advanced Bioprocessing (which sold to ThermoFisher in 2018 for $477M), and Commence Bio, Inc. a cellular immunotherapy company. Mr. Isett received his B.Sc. degree with Honors in Biological Sciences from Drexel University.
Marc Banjak
General Counsel
Mr. Banjak joins iBio with over 15 years’ experience in the biotechnology and contract research industries. He previously served as the first general counsel of both Istari Oncology and Dova Pharmaceuticals, leading the legal and compliance functions within both organizations. While at Dova, Mr. Banjak advised the company through a number of clinical and corporate milestones, including FDA and EMA approvals, a secondary public offering and the acquisition of Dova by Swedish Orphan Biovitrum AB. Prior to that, Mr. Banjak negotiated strategic contracts, advised on Foreign Corrupt Practices Act (FCPA) and Anti-Bribery matters, and labor issues at PRA Health Sciences. His industry experience spans rare disease biotechnology companies, global contract research organizations, and medical device companies. Prior to entering the biotechnology and contract research industries, Mr. Banjak served as an active duty officer in the U.S. Air Force in a variety of legal roles.
Mr. Banjak was admitted to the Colorado state bar. He earned his JD from the University of Denver School of Law and a BA in Psychology from Franklin and Marshall College.
Martin Brenner, DVM, Ph.D.
Chief Scientific Officer
Dr. Brenner has a strong history of success heading drug discovery and development teams at several of the world’s leading pharmaceutical companies, including AstraZeneca, Eli Lilly and Company, Pfizer Inc., and Merck Research Laboratories. Most recently, Dr. Brenner served as the CSO at Pfenex Inc., which, using its patented Pfēnex Expression Technology® platform, created an advanced pipeline of therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex was acquired by Ligand Pharmaceuticals Incorporated for approximately $516 million in October 2020.
Previously, Dr. Brenner served as the CSO at Recursion Pharmaceuticals, Inc., a company focused on accelerating drug discovery for rare diseases and diseases with high unmet medical need. Prior to his time at Recursion, he was Vice President and Head of Research & Early Development at Stoke Therapeutics, Inc., a biotechnology company using antisense oligonucleotides to increase gene expression for the treatment of rare diseases. Prior to Stoke, he was Executive Director at Merck, where he built a biotech unit from scratch, focusing his team’s research on diabetes and nonalcoholic steatohepatitis (NASH). Earlier in his career, Dr. Brenner was the Senior Director and Head of cardiovascular, renal, and metabolism (CVRM) biosciences at AstraZeneca. In addition, Dr. Brenner was an Associate Research Fellow at Pfizer where he led the islet biology and in vivo pharmacology in the CVMED Target Exploration Unit before assuming the role of Head of the Insulin Resistance Group.
Robert M. Lutz
Chief Financial & Business Officer
Mr. Lutz brings more than 25 years of experience to iBio, joining most recently from Strongbridge Biopharma plc, a Nasdaq-listed, commercial-stage biopharmaceutical company focused on rare diseases. He served as Strongbridge’s CFO since August 2019, and prior to that, as its Chief Business Officer since October 2014. During his tenure, he led the search, evaluation, contracting, and financing of multiple assets which proved to be critical growth drivers for Strongbridge.
Previously, Mr. Lutz spent more than a decade at Shire Pharmaceuticals in leadership positions with global responsibilities, including identifying opportunities for acquisition, licensing, partnership and development for Shire’s largest business unit (Neuroscience) and the financial management of approximately $5 billion in revenue for its Specialty Pharmaceuticals division. Prior to joining Shire, Mr. Lutz served in a variety of financial, strategic and executive positions after having started his career at Goldman Sachs & Company. He holds an MBA from the Kellogg School of Management and a BA in Economics and Computer Science from Amherst College.
Lisa Middlebrook
Chief Human Resources Officer
Ms. Middlebrook is a human resources executive with a strong record of accomplishment for achieving results within the CDMO and Generics arenas. Most recently, she served as Senior Vice President, Human Resources-The Americas at Lupin Incorporated, a global pharmaceutical company offering branded and generic formulations, biosimilars and active pharmaceutical ingredients. Previously, Ms. Middlebrook’s more than 13 years of progressive experience at Lonza Group included executive roles as Global Head of Human Resources (Lonza Bioscience), Global Head of Leadership Development and Talent Management (Lonza AG), Head Integration (Lonza Inc.), Head of Human Resources & Environmental Health and Safety (Lonza Bioscience), in addition to earlier positions in staffing, human resources and employee relations. She holds an MS in Organizational Development from Johns Hopkins University and a BS in Industrial Relations from LeMoyne College.
Randy Maddux
Advisor
Mr. Maddux has more than 20 years of global biologics drug development and manufacturing, business development and relationship management experience. Before joining iBio in December 2020, he was SVP and Chief Manufacturing Officer at Aptevo Therapeutics. Previously, Mr. Maddux was VP and Site Director at GlaxoSmithKline, where he led the largest biopharmaceutical development and manufacturing site within the GSK manufacturing network and was instrumental in launching a successful contract development and manufacturing (CDMO) services business. Prior to GSK, he was VP Quality and Operations at Human Genome Sciences and held positions of increasing responsibility within Biogen’s Quality organization. During his career, Mr. Maddux has served in key roles supporting the licensure and commercial launch of several biopharmaceutical products. He holds an MBA in Operations and Statistics from Duke University, Fuqua School of Business and a BS Professional in Analytical Chemistry from East Carolina University.
Brian R. Berquist, Ph.D.
Vice President of Process Development
Dr. Berquist is the Vice President of Downstream Process Development and Manufacturing at iBio CDMO. He has been the group leader for downstream process development since 2013 and performed or directed all downstream process development activities ranging from early-stage feasibility through scale-up and manufacturing.
Prior to his career in downstream process development, Dr. Berquist was a research assistant professor in the College of Medicine at the Texas A&M Health Science Center (2011 to 2013) investigating aspects of eukaryotic DNA replication and repair. From 2006 to 2011, Dr. Berquist performed his post-doctoral studies in the Lab of Molecular Gerontology at the National Institute of Aging, a part of the National Institutes of Health. He examined the molecular mechanisms behind premature aging and cancer-prone diseases under Dr. David M. Wilson III and Dr. Vilhelm Bohr. He earned a doctorate in Molecular Medicine from the University of Maryland School of Medicine in 2006 performing his graduate work in the lab of Dr. Shiladitya DasSarma.
Dr. Berquist’s training has encompassed genome sequencing and annotation, comparative genomic analyses, bioinformatics, molecular biology, microbial genetics, mammalian cell culture, confocal microscopy, protein purification, protein biochemistry, protein characterization, and enzyme kinetics. He currently utilizes all his scientific training and knowledge to aid and execute the design and implementation of downstream purification schemes for the clients of iBio CDMO.
Dr. Berquist has authored more than 25 peer-reviewed papers and book chapters.
Melissa Berquist, Ph.D.
Vice President and Head of Vaccines and Animal Health
Dr. Melissa Berquist brings nearly 15 years of livestock infectious disease experience to the role of head of animal health programs. During her professional career, Dr. Berquist has directed two national Science and Technology Centers of Excellence and a World Organisation for Animal Health Collaborating Centre in biological threat reduction. She has contributed to White House- level policy documents related to the development and implementation of national-scale biosecurity and biosurveillance activities and has operationalized technology products into use by customers. Dr. Berquist has a strong understanding of animal health industry drivers, markets, and trends to be able to identify unmet needs and deliver solutions for relevant stakeholders. Prior to joining iBio, Dr. Berquist served as director for the Institute for Infectious Animal Diseases (IIAD) within the Texas A&M University System, where she oversaw executive operations, provided scientific leadership, and synchronized the unit’s efforts related to strategic management, organizational change, and efficiency. Dr. Berquist also served as the IIAD’s associate director for six years, prior to taking over the director role in 2017. She joined the Texas A&M University System following three years at BAI, Inc., a professional services company in Alexandria, Va., first as a senior biosurety analyst and then as a senior analyst and program coordinator supporting scientific activities and programmatic implementation of national-level biodefense portfolios.
With diverse experience in delivering impactful tools and products to stakeholders and customers across the animal agricultural enterprise, she serves as a state-, national-, and global-level expert for a variety of animal health organizations. Dr. Berquist graduated from Northwestern University with a Bachelor of Science in biomedical engineering and earned her doctorate in molecular medicine/molecular and cellular biology as a Summa cum Laude graduate from the University of Maryland’s School of Medicine.
Mike Jenkins
Vice President, Operations
Dr. Jenkins has three decades of experience in operations, business development and consulting. Before joining iBio, he was Senior Vice President CMC at Ridgeback Therapeutics during BLA preparation and eventual approval of ansuvimab. Prior to Ridgeback, Dr. Jenkins worked as a Senior Consultant at Bioprocessing Technology Consultants where he managed CDMO clients in both cell and gene therapy. He’s held technical and business roles in the mammalian cell culture space, helping to establish Catalent’s GPEx technology for mammalian cell line engineering and serving as the General Manager during construction of Catalent’s cGMP manufacturing site in Madison Wisconsin. Additionally, Dr. Jenkins held positions with increasing responsibility at CropTech Corporation, a company with a novel, inducible system to produce recombinant proteins in tobacco plants. Dr. Jenkins has a BS in Microbiology from the University of Illinois and a PhD in Molecular and Cellular Biology from the University of Arizona, where he studied the molecular genetics of UV sensitivity in plants.
Lisa Johnson
Vice President, Quality
Ms. Johnson joins iBio with more than 30 years’ experience in the pharmaceutical and biotechnology industry. She has served in Quality leadership roles for Hospira, Celgene, Merck, and most recently held the position of Sr. Director of Quality for Sterile/Bio Internal Manufacturing for Bristol Myers Squibb. Prior to BMS, Ms. Johnson held the position of Executive Director of Quality for Merck’s Vaccine Manufacturing in Durham, North Carolina. Her quality experience spans small and large molecule for both bulk drug substance and finished parenteral drug product. She has experience in facility startup including construction, qualification, technology transfer, analytical validation, and regulatory compliance. Having hosted pre-approval inspections as well as general GMP inspections for manufacturing and testing facilities, she has extensive exposure to worldwide regulatory health authorities. Ms. Johnson holds an MBA in Business Operations Management from Meredith College and a BS in Chemistry from Barton College.
Peter Kipp, Ph.D.
Vice President of Platform Technology and Scientific Innovation
Pete brings over 20 years of experience in R&D operations, quality management and strategic planning across multiple life science disciplines. Combining diverse scientific training spanning plant biotechnology to oncology drug development with entrepreneurial leadership in process and technology development.
Pete spent the past four years in oncology drug development and discovery. As VP of Translational Medicine at Klus Pharma, Pete collaborated with colleagues in China to manage the progression of a portfolio of immuno-oncology mAb and ADC “bio-better” programs. As Director of Strategic Partnering for Champions Oncology, Pete built relationships with leading oncology clinicians at MD Anderson Cancer and Karmanos Cancer Institute. Pete led the industrialization of Lexicon Pharmaceuticals’ $250M reverse genetics program, converting an academic process into a business unit by devising and instituting a total quality management strategy. He acted as the alliance manager for Lexicon’s $12M Hypertension alliance with Takeda Pharmaceutical and led the project management function for Lexicon’s 250 FTEs engaged in early stage target validation programs in conjunction with collaborators at Genentech, BMS and Organon.
Pete routinely leads change management and operational improvement initiatives to increase R&D and operational productivity, reduce costs and improve strategic alignment in fast growing environments. Pete actively develops and advances new technologies and is an inventor on 6 issued US patents. He collaborates within the start-up community as a member of scientific advisory boards and is a 2-time NCI ICORPs mentor. Pete holds a BA in Biochemistry and Molecular Biology from Rice University, and a Ph.D. in Biochemistry, Molecular and Cellular Biology from Cornell University.
Matthew Luter
Vice President of Information Technology
Mr. Luter brings over 25 years of experience in the field of information technology. Before joining iBio, he served as Sr. Director, Information Technology - The Americas at Lupin Incorporated, a global pharmaceutical company. During his tenure as Sr. Director, he aligned IT functions across the Brazil, Mexico, U.S., and Canada regions and successfully deployed advanced security and threat mitigation tools across all four regions. His 11 years of progressive experience at Lupin saw him build the U.S. information technology enterprise from the ground up, serving in roles as Director – IT Infrastructure & Support, Sr. Manager – IT Infrastructure & Support, and Manager – Information Technology. Previously, Mr. Luter spent 14 years in engineering and other information technology related roles in the television, news media, and server hosting industries. He holds a BBA in Business Information Systems from Mississippi State University.
Dillon Phan, Ph.D.
Vice President and Head of Early Research and Development
Dr. Phan is an accomplished Drug Discovery leader with more than 15 years of industry experience in building and leading research teams to discover and develop therapeutic agents in diverse areas of unmet medical need. Most recently, Dr. Phan served as the director of In Vivo Pharmacology at Ferring Pharmaceuticals where he and his team conducted preclinical research to support Ferring’s global pipeline. Previously, he held a position as Associate Director of Drug Discovery at Pfenex where he established the preclinical drug discovery infrastructure and co-developed an innovative rare disease and oncology strategy. Prior to Pfenex, he was a Senior Investigator at The Genomics Institute of the Novartis Research Foundation where he led drug discovery programs in Type 1 Diabetes and Heart Failure indications. Dr. Phan spent 10 years at Gilead Sciences in the Cardiovascular Therapeutic Area after his postdoctoral fellow training at the University of Texas, Southwestern Medical Center. During his tenure at Gilead Sciences as Senior Research Scientist, Dr. Phan and his team identified and validated numerous targets, initiated drug discovery programs and co-led a novel kinase inhibitor program into the clinic for Diabetic Kidney Disease and Pulmonary Arterial Hypertension. Dr. Phan earned his Ph.D. at the University of Texas, MD Anderson Cancer Center in Molecular Pathology and his B.S in Genetics from the University of California at Davis.