GMP Plasmid DNA
Working in close contact with clients, Waisman Biomanufacturing uses novel methods to yield up to multi‐gram quantities of clinical grade plasmid DNA. We have established a platform manufacturing process and work‐flow for cell banking and to efficiently verify yield and quality prior to full scale cGMP production campaigns. For challenging, low expressing plasmids, Waisman has developed optional processing steps that can further reduce host genomic DNA and enrich for supercoiled plasmid in order to exceed plasmid DNA specifications for vaccine indications. Waisman has delivered plasmid DNA vaccines for Phase 1/2 clinical trials and can support Phase 3/commercial for plasmid DNA used as an ancillary material. Download our Plasmid Flyer to learn about all our services.
GMP Protein Production
Waisman offers superior quality recombinant protein process development and manufacturing services. Our strength lies in the ability to develop a customized process that is reproducible and fully scalable, yielding an end product that meets industry standards for FDA submission.
GMP Cell Therapeutics
Waisman cell culture specialists have a broad range of experience that enables us to optimize the culture parameters unique to each product cell line. Working in close contact with each client, we develop a culture process and timeline that meets program needs and cGMP/ICH cell banking requirements. The Waisman facility houses four ISO Class 7 Cell Processing Suites specifically designed for the cultivation of mammalian cells for use in 1) cell therapy applications including autologous cell processing, and 2) production of Master and Working Cell Banks for biotherapeutics production and ex-vivo gene therapies.
GMP Viral Vectors / Vaccines
Waisman has the expertise to assist you with the cGMP manufacture of a variety of viral vectors that include adeno-associated virus (AAV), adenovirus and lentivirus, or custom viral vaccines such as enteroviruses, rhinovirus, etc. Our top priorities are to streamline our platform processes or work with you to design a process that meets your specific needs and expedites your transition to the clinic. Whether your intended clinical use is direct injection or ex-vivo transduction, our viral vector team has years of experience in the production, purification, and characterization of viral products. Additionally, Waisman has created and fully tested a cGMP compliant HEK293 Master Cell Bank (adherent and serum free/ suspension) for use as a host cell system for viral vector production. Custom cell banks can be produced as well.
Waisman Biomanufacturing sells human FGF-basic (synonyms: FGF-basic, bFGF, FGFb, hFGF-2) produced under cGMP conditions for use in culturing stem cells for human clinical trials or in research applications that are anticipated to lead to clinical research.
> 90% total purity; > 75% monomer purity; 0.1 mg/mL in 1 mL volume; Low endotoxin (< 0.1 EU/ug); Demonstrated to support growth of undifferentiated embryonic stem cells
GMP Bone Marrow Derived Mesenchymal Stromal Cells
Waisman Biomanufacturing maintains banks of bone-marrow derived Mesenchymal Stromal Cells (BM-MSCs), also called Mesenchymal Stem Cells, produced under cGMP conditions for expansion and use in human clinical trials as well as in research applications that are anticipated to lead to clinical development.
Waisman Biomanufacturing has established cell culture processes and quality control methods for expanding MSCs for early stage clinical trials. Custom manufacturing projects can produce 2-4×10^9 cells per lot with final product packaged in vials or bags for human clinical trials.