1. 1. Downstream Processing: Purification
Purify protein product (biopharmaceutical) using largely chromatographic and filtration techniques.
Downstream processing serves to:
To ensure the protein is in the right confirmation and once there protect it from harm.
Remove any contaminants and prevent any contaminating substances or organisms from entering the product.
Ensure the protein is in the right solution and at the right concentration to prepare it for storage and injection into humans.

2. 2. Disposable Centrifuge
The Unifuge uses a disposable insert inside the centrifuge bowl.
The kSep technology balances centrifugal and fluid flow forces to capture cells in up to four disposable chambers.
Both contain:
Sterile disposable inserts
Fully automated, hands-off production
All product contact surfaces are 100% replaceable after each run
Both technologies involve retaining cells inside the centrifuge while the centrate that contains the product is continuously separated and discharged.
Unifuge
kSep System

3. 3. Disposable Depth Filtration
It consists of a set of inlet and outlet single use manifolds with vents and a flexible number of capsule filters placed between those manifolds.
Sartorius Sartoclear P
3M Zeta Plus
Pall Stax System
Millipore POD

4. 4. Disposable Mixing Systems
Advanced technology for mixing biopharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media.
Currently, the largest mixing system is 5000L, introduced in 2016 by ABEC

5. 5. Ready to Process Chromatography Columns
The columns are available with a range of media in different sizes. The columns are prepacked, presanitized, and prequalified.

6. 6. Membrane Chromatography
Suppliers
Sartorius Stedim Biotech - Sartobind
EMD Millipore - Chromasorb
Pall Corporation - Mustang
Natrix – HDQ
Chromatography Steps
Ion-Exchange (Cation and Anion)
Mixed Mode in Development
Capture - a potential alternative to Protein A

7. 6. Advantages/Disadvantages of Membrane Chromatography
Efficient
Higher throughput for trace impurity removal (g/h)
Economical
Save capital
No packing, regeneration
No re-use validation
95% less buffer consumption
Ease of Use
Disposable, simple set-up
Handle like a filter capsule
Disadvantages
Low binding capacity
Relatively new technology
Involves making change to existing bioprocess. Pre-packed columns provide industry with an integrated facility process.

8. 7. Benefits of Continuous Bioprocessing
Reduced costs:
Operating continuously allows use of much smaller scale equipment, with a smaller volume bioreactor operating over time resulting in as much product as larger equipment operated in fed-batch mode.
Smaller facility footprints are also required.
Increased productivity:
Most of the process equipment is operated continuously, so there is little need for large transfer/storage vessels and no halts between processes.
Improved quality:
Problems associated with proteolysis or other degradation over time in bioreactors and other vessels can be minimised.
If any problems occur, only part of the entire production run likely needs to be rejected.
Increased flexibility:
Continuous bioprocessing allows more adaptability and facility utilisation.
Ref: Continuous Bioprocessing. Current Practice & Future Potential. Refine Technology.

9. 8. Continuous Chromatography
As an alternative to traditional “batch” processes, new emerging
technologies such as periodic counter current chromatography (PCC)
are being developed.
Compared with a traditional batch set-up, the capacity of the
chromatography medium can be utilised to a greater extent in a
multi-column PCC setup.
Hence there are resultant decreases in;
Chromatography medium volume requirements
Buffer consumption
Processing times
Cost savings

10. Thank You
Nice work. I like the deck a lot.