Purify harvested biomaterial in biomanufacturing downstream processing (DSP) using chromatography

Business Sectors (Suites): Scientific Manufacture
Developed by: Cogent
Approved on: 30 Mar 2017


​This standard covers the competences you need to separate harvested biomaterial in biomanufacturing downstream processing operations using chromatography, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and equipment to be used. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will be required to present records and details of your biomanufacturing work to the appropriate people.

You will be required to check that the work area and equipment are ready for use, and that the appropriate resources and services are available, as stated in the instructions and standard operating procedures you are given. You wil lpurify biomaterial using chromatography for downstream processing (DSP). You will be required to prepare media for the size of column, to check and
assemble the column components, and to prepare and fill the column in accordance with instructions and procedures. You will also complete all the required documents and paperwork in accordance with these same instructions
and procedures.

Your responsibilities will require you to comply with health and safety requirements and organisational policy and procedures for the biomanufacturing work that is undertaken. You will be required to report any
problems with the health and safety procedures that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.

Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to different filtration procedures. You will have an understanding of the process of purifying of biomaterial by the chromatography, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.

You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect yourself and others in the workplace.

This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.

Performance criteria

You must be able to:

P1 ensure that your work is carried out in accordance with standard operating procedures
P2 wear the appropriate personal protection equipment (PPE) when working in a biomanufacturing environment
P3 prepare the filter unit and connect to the biomaterial source for downstream processing, in accordance with established practices and procedures
P4 pump biomaterial through the filter unit, monitoring and adjusting the flow-rate according to specification
P5 collect filtered biomaterial in the correct aseptic containers, and in the required quantities
P6 perform a filter unit integrity test, in accordance with established practices and procedures
P7 dispose of waste in the correct manner and location, and tidy and clean the work area, in accordance with established procedures
P8 communicate the required information about the work done, to authorised people, in accordance with departmental and organisational procedures

Knowledge and Understanding

You need to know and understand:

K1 the health and safety requirements of the area in which you are carrying out the biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities
K3 the standard operating procedures, as set down in local
biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operational instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and
process them
K7 the biomanufacturing materials and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for materials undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K13 the basic principle of purification using large-scale chromatography
K14 the procedures for loading, packing and setting plungers for optimal height in large-scale chromatography
K15 how to conduct packing tests (including inject, asymmetry and HETP)
K16 how to set pressure limits and flow rates of the buffer
K17 how to connect pipework to the system for processing
K18 how to monitor the system instrumentation
K19 how to store fractions and collect samples
K20 how to store, separate and dispose of waste in the correct manner
K21 the main differences between uniform and density gradient column materials
K22 how to store filled biomaterial containers for further processing


1. carry out all of the following procedures:
1.1 use the correct issue of job instructions and specifications
1.2 follow risk assessment procedures and COSHH regulations
1.3 prepare media for the size of column, and wash
1.4 check and assemble column components
1.5 pour chromatography material into the column, seal the column and set the plunger
1.6 conduct a packing test, and set the pressure limit and flow rate of buffer
1.7 connect pipework to the column and prepare for loading and collection of fractions
1.8 run the program for loading, and monitor system instruments
1.9 store the fractions in sterile containers, and send samples for analysis
1.10 stop the processing, clean in place and dispose of waste
1.11 store containers with the fractions in the correct location and quantities for further processing
1.12 store records of your activities, in accordance with appropriate procedures

2. use three of the following types of protective clothing and equipment:
2.1 laboratory coat/overalls
2.2 gloves
2.3 head/hair covers
2.4 safety shoes/shoe covers
2.5 safety glasses/visors
2.6 other (please specify)

3. load the column by both of the following methods:
3.1 manual loading
3.2 automated loading

4. fill the column with both of the following filter types:
4.1 uniform matrix
4.2 density gradient

5. conduct a packing test, to include all of the following:
5.1 inject
5.2 asymmetry
5.3 height equivalent to a theoretical plate (HETP)

6. set the system pressure limit for all of the following:
6.1 media type
6.2 column type
6.3 system type

7. collect fractions in all of the following:
7.1 sterile bags
7.2 sterile containers
7.3 sterile tubes

8. monitor all of the following system parameters:
8.1 pressure
8.2 fraction
8.3 pH
8.4 flow-rate
8.5 collection
8.6 uV
8.7 conductivity
8.8 temperature

9. separate outputs into all of the following categories:
9.1 waste for autoclaving
9.2 waste for flushing
9.3 waste for chemical cleaning
9.4 biomaterial product

10. record details of the work done, and communicate the details to the appropriate people, using:
10.1 verbal report
Plus one method from the following:
10.2 written or typed report
10.3 computer-based record
10.4 3 specific company documentation
10.5 electronic mail

Scope Performance

Scope Knowledge





Links To Other NOS

External Links

Version Number


Indicative Review Date

29 Mar 2019





Originating Organisation


Original URN


Relevant Occupations

Associate Professionals and Technical oc, Engineering and Manufacturing Technologies, Manufacturing Technologies, Science, Science and Engineering Technicians, Science and Mathematics Science

SOC Code



production; biomaterial; downstream; processing; chromatography; manufacturing; biomanufacturing; science