Downstream processes are those in which the products are harvested, tested, purified and packaged.
Upstream processes are those in which biological materials are either obtained from an outside source or inoculated and grown in culture, under controlled conditions, to manufacture certain types of products.
Many forms of biomanufacturing require technicians to carefully control the environment in which cells are grown or biological processes take place. If the final product will be used as a drug, biomanufacturing technicians will need to work together in environments where current Good Manufacturing Practices (cGMP) are strictly followed.
Technicians who carry out the complex steps in both upstream and downstream processes must communicate with each other and work together. They have to monitor equipment and pay attention to details.Full scale biomanufacturing requires technicians to work with other departments in a company, these departments may include - Process Development, Manufacturing, Regulatory, Quality, and Engineering Services - to define, design, develop and execute critical biomanufacturing processes , control parameters, and adhere to performance standards.
In pharmaceutical biomanufacturing, tasks are carried out in sterile or clean-room environments. In these environments, cells are grown in large stainless-steel bioreactors. The equipment for monitoring cell growth and purifying products is linked together by pipes and connected to electronic computerized controls.
Downstream Manufacturing Technicians harvest and purify recombinant proteins, or other products, obtained from the upstream cell expression systems. The downstream purification process starts with the material from the initial harvest and finishes with pre-formulation and the pure product. These technicians follow defined steps in order to produce as much material as possible, while minimizing loss. The technicians' goals are to produce a pure product, with a high yield, in an efficient manner.
Recombinant proteins are harvested and purified by a series of complimentary chromatography steps with intermediate filtration and other clearance steps. Downstream Manufacturing Technicians monitor control devices, perform column chromatography, carry out ultrafiltration, diafiltration, and other related operations. They run laboratory experiments including scaled down validation studies, test processes under different conditions, and measure the robustness of the process.
Their responsibilities include setting up area operations and performing clean-in-place (CIP) and sterilize-in-place (SIP) procedures with equipment used for cell growth. The Downstream Technician must also follow Standard Operating Procedures (SOPs) in accordance with a cGMP environment.
They troubleshoot biomanufacturing activities to come up with solutions in their teams. They maintain records to comply with all regulatory requirements. They may also package and label the final products.