Monoclonal Antibody Production

1
Monoclonal Antibody Production

• Viral Filtration
• DE-105
• Katharine Riley
• Joseph Lasowski

2
Overview

• Overall Process
• Location of Viral Filtration
• Background
• Why is it Important
• Unit Specifications
• Membrane Characteristics
• Dead-End vs. Cross Flow Filtration
• Process and Engineering Specifications
• Final Design and SuperPro
• Design Parameters
• Production Timeline
• Suppliers and Costing

3
Overall Process
Bioreactor
Viral Filtration
4
Background

• Why is in important?
• Inherent biological concerns for process
• Ensure safety and purity of final product
• What is it?
• Physiochemical methods of viral removal
• Use of porous membrane to separate
• based on size

5
Unit Specifications

• Membrane Characteristics
• Based on pore size varying filter abilities
• Viral filtration uses Ultrafiltration

http//www.kochmembrane.com/sep_uf.html
6
Unit Specifications

• Cross Flow
• Flow parallel to membrane surface
• Recyclable input stream
• Requires additional pump and separation

• Dead-End Flow
• Flow perpendicular to membrane surface
• Easier and cheaper design
• Possible concentration accumulation of filter

7
Unit Specifications

• Process and Engineering Specifications
• Based on system requirements
• Flow will determine diameter
• Influent concentration determine spacing
• Pressure drop determines length
• Due to influent conditions
• Chosen more stable membrane for greater pH and
  temperature variances

8
Final Design

• Final Product was SelRO MPS-U20P from Koch
  Membrane Systems

9
Final Design

• SuperPro Design
• Assumed bottleneck of Bioreactors alleviated
• Overall process cycle time 3.5 days
• 81 batches per year
• Viral Filtration DE 105
• Operates 0.47 days per batch
• Constant flow rate due to after bioreactor
• 1142.85 L/batch or 24000 L/day
• 2 filters in series
• reduction of filtration area
• does not greatly increase the labour required
• Able to reduce filter size from 1.4 m2 to 1.2 m2

10
Final Design
Design Parameter
Batch Time 50.04 days
Number of Batches 81
Production 1555 kg purified Mab/yr
Filtration Unit (DE-105) Volume
Number of filters per unit 2
Membrane Pore Size 0.02 µm
Filtration Area per filter 1.2 m2
Spiral Filter Diameter 6.35 cm
Volumetric flow rate through DE-105 1142.85 L/batch
24000 L/day operational
DE-105 Operation time 0.47 days/batch
Minimum flow rate 10800 L/day operational
Maximum flow rate 27000 L/day operational
Temperature 25oC
Pressure 10.13 bar
11
Suppliers and Costing

• Suppliers
• Able to successfully find three suppliers
• Koch Membrane Services
• Niro Inc.
• Remco Engineering
• Unable to find costing from suppliers
• Costing from SuperPro of
• 13,356.00 per membrane
• 2,163,672.00 annually
• 9.5 of the cost of consumables

12
Questions