Waisman Biomanufacturing

What Waisman Biomanufacturing does

Waisman Biomanufacturing (WB) is a U.S. contract development and manufacturing organization (CDMO) that produces CGMP-grade novel therapeutics for Phase I and Phase II human clinical trials. The company operates from a single facility at 1500 Highland Avenue, Madison, Wisconsin, situated within the University of Wisconsin-Madison campus under an industry-academia hybrid model. WB serves small and large biotechnology companies, academic research institutions, and federal agencies, manufacturing plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicles/secretomes, live biotherapeutic products, and aseptic filled/finished vials.

The technical platform centers on multi-product CGMP manufacturing suites with segregated production areas, bioreactor capacity of 30-250L (microbial) and 50-250L (mammalian), multi-tray formats, scalable chromatography and tangential flow filtration, a fully automated Aseptic Technologies Crystal SL1 vial dispensing and capping line inside an ISO Class 5 barrier isolator (up to 2,000 vials per lot), and the first CGMP facility capable of banking human embryonic stem cells and producing iPSC-derived Master Cell Banks. Process development, quality control (HPLC, PCR, ELISA, sterility, endotoxin, custom assays), and QA/regulatory support including CMC filings and Type V Facility Master File cross-reference complete the service portfolio. The company reports having supported the delivery of over 70 FDA INDs and hundreds of clinical-grade products since inception.

Commercially, WB generates revenue through project-based, multi-year contract manufacturing engagements. Pricing is quote-based and tailored to each program's scope, timeline, and product characteristics; clients engage via direct business development outreach led by the Director of Business Development, supplemented by technical content marketing, conference presence, and inbound inquiries via the company website. Customer logos include RoosterBio, Cynata Therapeutics (the world's first allogeneic iPSC-derived clinical trial), BriaCell, Heat Biologics, GigaGen, Agilis Biotherapeutics, and prior collaborations with BARDA and UW-Madison. Capacity supports up to 20 active clients concurrently, and the operating model emphasizes flexible, collaborative project management over high-volume production.

Name

Waisman Biomanufacturing

Legal name

Waisman Biomanufacturing

Website

https://gmpbio.org

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Waisman Biomanufacturing is a UW-Madison-affiliated CGMP CDMO in Madison, Wisconsin that manufactures plasmid DNA, recombinant proteins, cell therapeutics, EV/secretome products, live biotherapeutic products, and aseptic filled/finished vials for Phase I and Phase II clinical trials.

Ownership category

akta.pro rank

Product category

Contract Biomanufacturing Services

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

akta.pro secondary industries

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC), Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

Keywords

• CGMP biomanufacturing
• Plasmid DNA manufacturing
• Cell therapy manufacturing
• Aseptic fill finish
• Contract development manufacturing

Headquarters

HQ city

Madison

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. Contract Manufacturing Services: Waisman Biomanufacturing generates revenue through contract development and manufacturing services for biopharmaceutical companies, universities, and federal agencies. Services include process development, GMP manufacturing, quality control, QA/regulatory support, and aseptic fill/finish for various biologic products including plasmid DNA, recombinant proteins, cell therapeutics, EVs/secretomes, and live biotherapeutic products. The revenue model is project-based with dedicated project managers assigned to each client engagement.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

Waisman Biomanufacturing is a Contract Development and Manufacturing Organization (CDMO) providing cGMP manufacture of novel therapeutics for Phase I/II clinical trials. The company produces plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicles/secretomes, and live biotherapeutic products, supported by process development, quality control, aseptic fill/finish, and QA/regulatory support services.

Product overview

Waisman Biomanufacturing is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end biomanufacturing services for novel biologics and vaccines into early clinical trials. The portfolio consists of clinical production services (GMP Plasmid DNA, GMP Protein Production, GMP Cell Therapeutics, GMP EV/Secretome, GMP Live Biotherapeutic Products, and Aseptic Fill/Finish) supported by process development, quality control, and regulatory/QA services. As an industry-academia hybrid affiliated with the University of Wisconsin-Madison, the company offers a collaborative, flexible approach to translating client benchtop processes into scalable CGMP manufacturing suitable for Phase I/II clinical trials.

Differentiator

Problem solved

Functional benefit

Products and services

• GMP Plasmid DNA cGMP-grade plasmid DNA manufacturing yielding multi-gram quantities via high-yield fermentation with no animal-derived enzymes or organic solvents, scalable to 30-120L steam-in-place fermentor capacity, for direct injection or ex-vivo/further manufacturing applications supporting Phase 2 clinical trials.
• GMP Protein Production Recombinant protein manufacturing using bacterial or mammalian host cells with 30L fermentation and 50-250L mammalian cell culture capabilities, cell harvest by centrifuge or filtration, protein refolding, and scalable downstream processing.
• GMP Cell Therapeutics Mammalian cell therapy manufacturing with suspension and adherent capabilities, large-scale bioreactor and multi-tray production, vial/cryobag container formats, and Master/Working Cell Bank creation for allogeneic and autologous applications.
• GMP EV / Secretome cGMP manufacturing of extracellular vesicles and secretome products from stem cells or other mammalian cells at 50-250L bioreactor or multi-tray formats for Phase 1/2 clinical trials, with scalable chromatography and tangential flow filtration purification.
• GMP Live Biotherapeutic Products Custom development and manufacturing of live biotherapeutic products up to Biological Safety Level 2, including high-density aerobic fermentation, harvest/wash by tangential flow filtration, and closed downstream processes validated via media fill studies.
• Aseptic Fill / Finish Validated aseptic fill/finish capabilities using fully automated dispensing and capping with a robotic fill line housed in a barrier isolator achieving ISO Class 5 environment, supporting ISO 2R/6R/10R vial formats up to 2,000 unit capacity.
• Process Development Transition of benchtop protocols to scalable, cGMP-compliant processes including microbial fermentation, mammalian cell culture development, and downstream processing optimization for client biologics programs.
• GMP Manufacturing Custom contract manufacturing of biologics for human clinical trials including plasmid DNA, cell therapeutics, viral vectors, vaccines, and recombinant proteins under cGMP guidelines for Phase I/II clinical trials.
• Quality Control Comprehensive analytical testing services including HPLC, PCR assays, ELISAs, sterility testing, endotoxin testing, and custom assay development for product release and stability testing.
• QA and Regulatory Support cGMP documentation management, batch release review, vendor audits, and CMC regulatory filing support including eCTD format and Type V Facility Master File cross-reference capability.
• GMP hES Cells Human embryonic stem cell Master Cell Banks (H1/WA01, H9/WA09, H14/WA14) produced under cGMP compliance for differentiation and use in human clinical trials.

Quantifiable outcome

• 70+ FDA INDs delivered for regulatory filings in US and global markets
• +3 more outcomes

Named customers8 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• RoosterBiocoreStrategic or Co-development Partner · 6 February 2024Collaboration announced February 6, 2024 for GMP manufacturing of cell and exosome therapies. Waisman provides manufacturing services while leveraging RoosterBio's cell culture and downstream processes. Includes technology transfer of Rooster Bio cell culture and downstream processes for EV/secretome production.
• WiCellcoreStrategic or Co-development PartnerOngoing collaboration for human embryonic stem cell banking. Waisman utilizes hESCs from WiCell to create Working Cell Banks for client projects. Partnership includes H9 (WA09) and H14 (WA14) cell lines.
• Cynata TherapeuticscoreTechnology or IntegrationManufacturing partnership for iPSC-derived cell therapy products. Waisman manufactured clinical-grade material for the world's first allogeneic iPSC-derived cell therapy clinical trial (CYP-001 for GvHD).

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Resilience: Resilience is a US-based biologics CDMO focused on complex modalities including cell therapies, gene therapies, and biologics — directly comparable in modality mix and target customer segments to Waisman's emerging-therapeutic focus.
• Bionova Scientific: Bionova Scientific is a boutique biologics CDMO offering process development, GMP manufacturing, and aseptic fill-finish for Phase I/II clinical trials — closely comparable in scale, scope, and target customer base to Waisman's early-stage clinical material focus.
• AGC Biologics: AGC Biologics provides microbial and mammalian cell-based CDMO services, including plasmid DNA and cell therapy manufacturing, with comparable offerings in early-stage clinical biologics production.
• Genezen: Genezen is a viral vector and gene therapy CDMO offering GMP manufacturing for lentiviral and AAV vectors — comparable in scale and clinical-stage focus, particularly relevant given Waisman's plasmid DNA and gene therapy-adjacent capabilities.
• Aldevron: Aldevron (now part of Danaher) is a US-based biologics CDMO specializing in plasmid DNA, mRNA, recombinant proteins, and antibody manufacturing for clinical and commercial stages — directly comparable to Waisman's core plasmid DNA and recombinant protein manufacturing services.
• KBI Biopharma: KBI Biopharma is a contract development and manufacturing organization offering microbial fermentation, mammalian cell culture, and analytical services for biologics — directly comparable to Waisman's recombinant protein and microbial manufacturing capabilities.

Emerging players

• Cellular Origins: Cellular Origins is an emerging CDMO specializing in automated cell therapy manufacturing — relevant as an emerging competitor in the cell therapy manufacturing space where Waisman also operates.

Broad incumbents

• Lonza: Lonza is the world's largest biologics CDMO with comprehensive mammalian and microbial manufacturing, cell and gene therapy services, and aseptic fill-finish capabilities — a broad incumbent competing across the same modalities as Waisman.
• Fujifilm Diosynth Biotechnologies: Fujifilm Diosynth is a large CDMO providing process development and GMP manufacturing for recombinant proteins, vaccines, and cell/gene therapies — a broad incumbent with overlapping early-stage clinical manufacturing services.
• Catalent: Catalent is a major global CDMO offering biologics, cell and gene therapy, and aseptic fill-finish services across all clinical and commercial stages — a broad incumbent where Waisman's Director of Operations Scott Smith previously worked.

Market position

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/WaisBio
• LinkedInlinkedin.com/company/waisman-biomanufacturing

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Waisman Biomanufacturing