Platzhalter Bild “Current Best Practise in Biomanufacturing and the Critical Role of Innovation” International Vellore Symposium “Bioprocess Industry-Academia Interaction” July 2011 Dr. Uwe Gottschalk, VP Purification Technologies, Sartorius Stedim Biotech
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Platzhalter Bild
“Current Best Practise
in Biomanufacturing
and the
Critical Role of Innovation”
International Vellore Symposium “Bioprocess Industry-Academia
Interaction”
July 2011
Dr. Uwe Gottschalk, VP Purification Technologies, Sartorius Stedim
Biotech
What
are
the
hot Topics?
7th Annual Survey of Biopharmaceutical Manufacturing. Eric S. Langer, BioPlan
Associates Inc.
Existing Facilities to Meet Current Challenges
Data adapted from: F. Wurm
Production of recombinant Protein Therapeuticsin Cultivated Mammalian Cells. Nature Biotechnology 22, 1-6 (2004)
The
USDP/DSP Interface in a World of High Titers
Jim Davis, Lonza
Economics of Monoclonal Antibody Production: The relationship between upstream titer and downstream costs; IBC San Diego March 2008
DSP is
Mass
not
Volume
driven
Current
Best Practise
in DSP
Increasing biomass and contaminant levels
Protein A pool volumes and step cost
DNA & HCP levels post Capturing
Polishing load volumes and conductivity
Pathogen clearance as a moving target
High Titer
Implications:
Chromatography Technologies for DSP
Polishing
(Membranes)
• Highly porous structure
• Pore size: 3 –
5μm
• Convective Flow
• Minimal buffer useCapturing/IP
(Resins)
• Bead size distribution: 15 -160 μm
• Average pore size: 15 -
40 nm
• Diffusion limited flow
• High capacity
Capture Costs: Why bother?
Jim Davis, Lonza
Economics of Monoclonal Antibody Production: The relationship between upstream titer and downstream costs; IBC San Diego March 2008
Emerging capture
technologies expected to have limited market potential in upcoming years
Source: Sartorius
MaturityMaturity RiskRiskDescriptionDescription
•
CIM, BIA Separations, methacrylate
based monoliths•
Similar to membrane adsorbers•
Purification of large biomolecules
(viruses, plasmid DNA, conjugates), good resolution
•
Upfront/DSM work on single use technology for MABs•
Already used in depletion of valuable biomolecules
from particle containing feedstreams
at large scale (milk, juice, etc.)
•
Membrane adsorber
technology•
Own development and IP, depletion of valuable biomolecules
from particle containing feedstreams
•
Currently low priority, combines cell harvest and capture chromatography step
•
instAction, Prometic
(mimetic ligands), BAC, GEHC pipeline, Repligen
Protein A
•
Used at large scale in plasma fractionation (precipitation)
and APIs (crystallization)•
Not developed for mABs
•
Polybatics•
Disruptive technology•
Single use alternative to Protein A•
Platform character
TechnologyTechnology
Monoliths
Expanded bed ad-
sorption
Direct Capture MA
Ligands
Precipitation/Crystallization/
Extractionn
Affinity
nano-
particles
RelevanceRelevance
•
No significant market in upcoming years expected –
Potential for Niches (e.g. Vaccines, DNA)
•
No immediate commercialization possible
•
Potential for disruptive technology
Capt
ure
and
inte
rmed
iate
pur
ific
atio
n
Already used In development Start of development Low risk Moderate risk High risk