Protein therapeutics development and manufacturing, which include monoclonal antibodies as well as recombinant proteins, is a highly complex process. In both process development as well as commercial manufacturing, the protein therapeutics workflow includes cell optimization, cell culture, harvest, purification, formulation and fill and finish.
Gene and gene-modified cell therapies treat diseases by delivering therapeutic DNA into a patient’s cells. The first step is packaging a therapeutic transgene into a delivery vehicle (e.g., a viral vector), followed by expansion of its host cell lines to produce high-enough vector concentrations.
Vaccine manufacturing typically takes 6-36 months. While the sequence of operations, the specific cycles for each product and filling and lyophilization equipment may vary, there are common equipment across platforms such as bioreactors, filtration and chromatography equipment.
The process for the production of veterinary vaccines is similar to the process for developing and manufacturing vaccines for human use.