WHY WAISMAN Services and Products

With broad and comprehensive capabilities, Waisman Biomanufacturing is uniquely situated and highly qualified to lead clients through the complex process of bringing a novel therapeutic into the clinic. Integral to any product campaign is a well thought-out product development plan. You can rely on our business manager and team of project leaders to work closely with you to maintain an on-going flow of communication and develop a time and cost effective plan that meets your needs. Utilizing our expertise in both Quality Assurance/Control and Process Development/Manufacture we can translate your bench top process to a large scale manufacturing process. Using this strategy Waisman routinely produces cGMP grade material qualified for clinical trials for a wide variety of applications.

 

Waisman has expertise to assist with your contract manufacturing needs for novel biotherapeutics and vaccines that include:

 

Microbial Products - Microbial cell banking, plasmid DNA, recombinant proteins (e.g., vaccine antigens), microbial cellular therapeutics.

Cell Therapeutics - Cellular therapies including human embryonic stem cells (hESCs), mesenchymal stromal cells (MSCs), neural progenitor cells (NPCs), mammalian cell banking.

Mammalian Products - Gene therapy vectors (adenovirus, AAV, lentivirus), viral vaccines, and recombinant proteins including monoclonal antibodies in mammalian expression systems (e.g., CHO, HEK-293, MRC-5, Vero cell lines).

Aseptic Finish/Fill - Liquid aseptic fill including recombinant proteins, gene therapy vectors (DNA, viral vectors), and small molecule drugs.

Process Development - Full support for clinical process development including microbial fermentation, cell culture, research cell banking, and downstream processing for recombinant proteins, plasmid DNA, and viral vectors/vaccines.

Quality Control - Comprehensive product testing and analytical methods development/qualification/validation to support process development and cGMP release testing.

Quality Assurance - Review of cGMP batch records and release, full quality system support, and vendor audit support.

Regulatory Affairs Support – Support for writing of Chemistry, Manufacturing, and Controls (CMC) sections of IND filings as well as access to the Waisman Biomanufacturing Drug Master File (DMF) with FDA.