Downstream processes are those in which the products are harvested, tested, purified and packaged.
Education & Training:
Manufacturing technician positions generally require a two-year Associate in Applied Science (A.A.S.) degree. Degrees or certificates may be named biotechnology, bioprocess technology or industrial pharmaceutical technology. Further training can be obtained with a four-year Bachelor of Science (B.S.) degree in Biomanufacturing. Colleges and university degrees in microbiology or biopharmaceutical science can also be helpful.
In some areas, companies specify the BioWork certificate (North Carolina) or an Associates degree.
Commonly requested abilities
- Work in a clean room
- Be able to work on your feet for several hours
- Lift 50 lbs
- Adaptable to changing needs
Downstream biomanufacturing processes are those in which the products are harvested, tested, purified and packaged.
Upstream biomanufacturing involves cell culture. In the upstream processes, the cells are 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 work 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 need 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 carry out 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 or increasingly in single-use reactors. 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, that are obtained from the upstream cell expression systems. The downstream purification process starts with 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. Their 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 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 for their teams. They maintain records to comply with all regulatory requirements. They may also package and label the final products.