Recently on our blog
Annual Preventive Maintenance: Why It Matters for Clinical Trial Reliability
When most people think of clinical trials, they picture groundbreaking therapies, complex regulatory submissions, and dedicated scientists working to bring hope to patients. Rarely does anyone picture an air compressor, a chromatography skid, or the countless sensors humming in the background. Yet these systems are the unsung heroes of every clinical trial, and their reliability often determines whether an investigational drug makes it safely into the hands of patients. At Waisman Biomanufacturing, we understand that operational excellence is more than a checklist. It is a story of foresight, discipline, and care. One of the most important chapters in that story is annual preventive maintenance.
Plasmid DNA
- High yield fermentation
- No enzymes or organic solvents
- Scalable production process
- Multi-gram capacity
- Direct injection or ex-vivo/further manufacturing applications
Recombinant protein
- Bacterial / mammalian hosts
- 30L fermentation / 50-250L mammalian cell culture
- Cell harvest by centrifuge or filtration
- Protein refolding
- Scalable downstream processing
Cell therapeutics
- Suspension / adherent manufacturing capabilities
- Large scale bioreactor / multi-tray production
- Vial / cryobag container formats
- Controlled cryopreservation
EV/Secretome
- Mammalian cell extracellular vesicle (EV) / Secretome products
- 50-250L bioreactor / multi-tray formats
- Scalable chromatography and TFF (tangential flow filtration)
- Platform and custom analytical methods
Live Biotherapeutic Products
- Custom development of high yield fermentation
- Harvest/wash by TFF
- Experience with aseptic process simulation of full manufacturing process
Aseptic fill/finish
- Fully-automated dispensing / capping
- ISO 2R/6R/10R vial formats
- 2,000 unit capacity
- Prior media fill simulations and container closure integrity with annual requalification
Leadership
Christopher Bartley
Managing Director
Christopher Bartley is the Managing Director of Waisman Biomanufacturing, bringing over 20 years of experience in research and product development. With a B.S. in Bacteriology from the University of Wisconsin-Madison, he has played a key role in developing and manufacturing biologics, specializing in fermentation, bioreactor controls, and downstream processing.
Scott Smith
Director of Operations
Scott Smith, Director of Operations at Waisman Biomanufacturing, brings over two decades of progressive leadership in biomanufacturing and operations management within the biotechnology and pharmaceutical sectors. With a Bachelor of Science in Management and an Associate of Applied Science in Biotechnology, Scott has cultivated deep expertise in upstream and downstream cGMP manufacturing, fermentation, and protein purification.
Brian Dattilo
Director of Business Development
Brian Dattilo, Ph.D., is the Director of Business Development at Waisman Biomanufacturing, bringing extensive experience in recombinant protein production and biopharmaceutical development. With a background in both public service and industry, he specializes in client engagement, technical product development, and strategic investment in novel platform technologies.
John Vedo
Director of Quality Assurance
John Vedo, Director of Quality Assurance at Waisman Biomanufacturing, brings 20 years of experience in pharmaceutical and biotech cGMP environments. With a B.S. in Biology from Indiana University and an M.B.A. from DePaul University, he leads a team of quality professionals to ensure regulatory compliance and uphold industry standards.
Rita Stiemke
Director of Quality Control
Rita Stiemke, Ph.D., is the Director of Quality Control at Waisman Biomanufacturing, bringing extensive experience in cGMP-compliant quality testing, method development, and validation for biopharmaceutical products. With a background in chemical engineering and pharmaceutical sciences, she leads a team of QC specialists to ensure rigorous product release and stability testing in collaboration with clients and internal teams.
Your Industry-Academia Hybrid CDMO
Strategically part of the University of Wisconsin-Madison, WB maintains industry-standard facilities, equipment, and quality systems with a scientific staff that provide a highly flexible and collaborative project management approach. WB has a proven track record for producing high-quality clinical trial material for both large and small biotech companies, universities, and federal agencies for regulatory filings in the US and other global markets.
Waisman Biomanufacturing has manufactured hundreds of clinical grade products since inception in 2001 and has earned a reputation as a strategic partner for cost effective and timely delivery. We strive to meet these high standards with each manufacturing campaign or development program.
Partner with us today!
Contact us