Monitor the purification of harvested biomaterial in biomanufacturing downstream processing using chromatography

Business Sectors (Suites): Scientific Manufacture
Developed by: Cogent
Approved on: 29 Apr 2021


This standard covers the competences you need to monitor the purification of biomaterial in biomanufacturing downstream processing using chromatography, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and equipment that is 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 will purify biomaterial using chromatography for downstream (DSP) processing. You will be required to prepare media for the size of column, to assemble and check column components, and to fill and prepare 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 biomanufacturing activities 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 applying procedures for the monitoring of biomaterial purification by chromatography. You will have an understanding of the purifying of biomaterial by the chromatography process, 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:

1 ensure that your work is carried out in accordance with standard operating procedures

2 wear the appropriate personal protection equipment (PPE) when working in the biomanufacturing environment

3 prepare chromatography system and connect to biomaterial source for downstream processing, in accordance with established practices and procedures

4 collect purified biomaterial in the correct aseptic containers and required quantities

5 dispose of waste in the correct manner and location, and tidy and clean the work area, in accordance with established procedures

6 monitor and lead the quality and delivery of the above outcomes for yourself and your team

7 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:

1 the health and safety requirements of the area in which you are carrying out the biomanufacturing activities

2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities

3 the standard operating procedures, as set down in local biomanufacturing operating manuals

4 the importance of following equipment manufacturers' operating instructions

5 the principles of Good Manufacturing Practice (GMP) applied in the workplace

6 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

7 the biomanufacturing materials and batch process tracking and records system

8 the types of handling and sorting system, and the procedures used for materials undergoing processing in the manufacturing facilities

9 the importance of correct identification, and any unique organisational or manufacturing numbers

10 the organisational requirements for maintaining the security of the workplace

11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation

12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve

13 how to monitor and lead the quality and delivery of the purification of biomaterial in biomanufacturing downstream processing using chromatography

14 the basic principle of purification using large-scale chromatography

15 the procedures for loading, packing and setting plungers for optimal height in large-scale chromatography 16 how to conduct packing tests (including inject, asymmetry and HETP)

17 how to set pressure limits and flow rates of the buffer solution

18 how to connect pipework to the system for processing 19 how to monitor the system instrumentation

20 how to store fractions and collect samples

21 how to store, separate and dispose of waste in the correct manner

22 the main differences between uniform and density gradient column materials

23 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 it 1.4 assemble and check column components

1.5 pour chromatography material into the column, seal the column and set the plunger

1.6 conduct a packing test, set the pressure limit and flow rate of the buffer solution

1.7 connect pipework to the column and prepare for loading and collection of fractions

1.8 run the program for loading, and monitor the system instruments

1.9 store 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 fractions in the correct location and required quantities for further processing

1.12 store records of your activities, in accordance with appropriate procedures

  1. 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)

  1. control the loading of columns by both of the following methods:

3.1 manual loading 3.2 automated loading

  1. control the filling of columns with both of the following filter types:

4.1 uniform matrix 4.2 density gradient

  1. 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)

  1. monitor the setting of the system pressure limit for all of the following:

6.1 media type 6.2 column type 6.3 system type

  1. monitor the collection of fractions in all of the following: 7.1 sterile bags

7.2 sterile containers 7.3 sterile tubes

  1. monitor all of the following system parameters:

8.1 pressure

8.2 fraction 8.3 pH

8.4 conductivity 8.5 flow rate 8.6 collection 8.7 UV

8.8 temperature

  1. control the separation of 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

  1. 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 specific company documentation 10.5 electronic mail

Scope Performance

Scope Knowledge





Links To Other NOS

External Links

Version Number


Indicative Review Date

29 Apr 2026





Originating Organisation


Original URN


Relevant Occupations

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

SOC Code



production; team-leading; biomaterial; downstream; processing; chromatography; manufacturing; biomanufacturing; science