Waisman Biomanufacturing
University-affiliated contract development and manufacturing organization providing CGMP process development, analytical testing, and clinical-stage manufacturing for biologics and vaccines. Offers pilot and clinical-scale production (plasmid DNA, recombinant proteins, viral vectors, cell therapeutics, extracellular vesicles/secretomes, and live microbial products), quality control and assurance services, and regulatory support for IND-stage programs.
Industries
Nr. of Employees
small (1-50)
Waisman Biomanufacturing
Products
GMP Master Cell Banks (hES lines)
Human embryonic stem cell Master Cell Banks produced under GMP for use in differentiation, clinical manufacturing and as working banks for individual projects (examples include H1, H9, H14 lines indicated on the site).
Clinical-grade plasmid DNA batches
Platform-produced plasmid DNA suitable for direct injection or ex vivo manufacturing applications, available at milligram to multi-gram scales with regulatory-focused QC (supercoil content, host impurities).
CGMP EV / Secretome product manufacturing
Manufacture and purification of extracellular vesicle and secretome products at clinical scale with supporting analytical characterization and aseptic final packaging options.
Aseptic Fill / Finish
Validated aseptic fill/finish capabilities offering an in-house validated process for pilot-scale CGMP aseptic fills, ranging from hundreds up to 2,000 vials for clinical trials.
GMP Plasmid DNA
Waisman's platform plasmid manufacturing process yields up to multi-gram quantities of clinical, CGMP grade plasmid DNA that can be used for direct injection or ex-vivo/further manufacturing applications.
GMP Manufacturing
Custom manufacturing of plasmid DNA, recombinant proteins, live microbial products, viral vectors/vaccines, cell therapeutics, or standalone aseptic fills for human clinical trials.
GMP Master Cell Banks (hES lines)
Human embryonic stem cell Master Cell Banks produced under GMP for use in differentiation, clinical manufacturing and as working banks for individual projects (examples include H1, H9, H14 lines indicated on the site).
Clinical-grade plasmid DNA batches
Platform-produced plasmid DNA suitable for direct injection or ex vivo manufacturing applications, available at milligram to multi-gram scales with regulatory-focused QC (supercoil content, host impurities).
CGMP EV / Secretome product manufacturing
Manufacture and purification of extracellular vesicle and secretome products at clinical scale with supporting analytical characterization and aseptic final packaging options.
Aseptic Fill / Finish
Validated aseptic fill/finish capabilities offering an in-house validated process for pilot-scale CGMP aseptic fills, ranging from hundreds up to 2,000 vials for clinical trials.
GMP Plasmid DNA
Waisman's platform plasmid manufacturing process yields up to multi-gram quantities of clinical, CGMP grade plasmid DNA that can be used for direct injection or ex-vivo/further manufacturing applications.
GMP Manufacturing
Custom manufacturing of plasmid DNA, recombinant proteins, live microbial products, viral vectors/vaccines, cell therapeutics, or standalone aseptic fills for human clinical trials.
Services
Bench-to-clinic process development including microbial fermentation, mammalian cell culture optimization, research cell banking, downstream purification, formulation and stability studies.
Clinical-stage manufacturing campaigns for plasmid DNA, recombinant proteins, viral vectors, cell therapeutics, EV/secretome products and live microbial products in segregated suites with CGMP documentation.
In-house analytical testing, assay development, qualification and validation to support process development and CGMP release testing, including HPLC, qPCR, ELISA, particle sizing, flow cytometry and microbiology.
QA oversight for CGMP documentation, batch review and release, audit facilitation, CAPA management, and preparation of CMC sections for regulatory submissions (eCTD Module 3) and facility master file cross-referencing.
Validated pilot-scale aseptic filling and capping inside barrier isolators with environmental monitoring, container closure integrity testing and validation via media fill simulations.
Creation and expansion of Master and Working Cell Banks, controlled cryopreservation, storage, and GMP production of cell therapy products including MSCs, iPSC-derived products and other mammalian cell types.
Bench-to-clinic process development including microbial fermentation, mammalian cell culture optimization, research cell banking, downstream purification, formulation and stability studies.
Clinical-stage manufacturing campaigns for plasmid DNA, recombinant proteins, viral vectors, cell therapeutics, EV/secretome products and live microbial products in segregated suites with CGMP documentation.
In-house analytical testing, assay development, qualification and validation to support process development and CGMP release testing, including HPLC, qPCR, ELISA, particle sizing, flow cytometry and microbiology.
QA oversight for CGMP documentation, batch review and release, audit facilitation, CAPA management, and preparation of CMC sections for regulatory submissions (eCTD Module 3) and facility master file cross-referencing.
Validated pilot-scale aseptic filling and capping inside barrier isolators with environmental monitoring, container closure integrity testing and validation via media fill simulations.
Creation and expansion of Master and Working Cell Banks, controlled cryopreservation, storage, and GMP production of cell therapy products including MSCs, iPSC-derived products and other mammalian cell types.
Expertise Areas
- Clinical trial material manufacturing (Phase I/II)
- Process development and scale-up for biologics
- Plasmid DNA manufacturing
- Cell therapy manufacturing and cell banking
Key Technologies
- Tangential flow filtration (TFF)
- Column chromatography
- Single-use and bench-to-pilot bioreactors (2.5–250 L)
- Continuous and batch centrifugation
News & Updates
Press release describing collaboration for GMP manufacturing of cell and exosome therapies.
Announcement of completed initial process transfer from RoosterBio.
Publication of a Phase 1 clinical trial of a DNA–protein HIV vaccine (linked on site).
Organization states it has partnered to deliver over 70 US FDA Investigational New Drug applications during its history.
Press release describing collaboration for GMP manufacturing of cell and exosome therapies.
Announcement of completed initial process transfer from RoosterBio.
Publication of a Phase 1 clinical trial of a DNA–protein HIV vaccine (linked on site).
Organization states it has partnered to deliver over 70 US FDA Investigational New Drug applications during its history.