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Day 1 |
Day
2
8:35 Recombinant Expression
and Purification of the Hepatitis C Envelope Protein
E1 in the Yeast Hansenula polymorpha
Joost Haelewyn, Ph.D.,
Purification Manager, Biologics, GENimmune NV
The
methylotrophic yeast Hansenula polymorpha was used
as a production system for the hepatitis C virus (HCV)
envelope protein E1, a potentially relevant protein in the
context of HCV treatment or prophylaxis. But while
recombinant, core-glycosylated E1 accumulates
intracellularly in yeast endoplasmic reticulum, the
hydrophobic nature of E1, and its tendency to
spontaneously form aggregates complicate the purification
process. We therefore developed a strategy to overcome
these challenges and established a first-generation
production process whereby batches of E1 drug substance
were produced according to cGMP standards to support
toxicity studies and clinical trials (phase 1 and 2).
During clinical trials, the production process was further
improved and optimized at the process-development scale,
which resulted in a fully scalable second-generation
production process with a 10-fold higher overall E1 yield.
Various cGMP-related issues were also resolved.
9:05 Producing Recombinant
Proteins and Antibodies in the Chloroplasts of Microalgae
Peter B. Heifetz, Ph.D., Chief
Scientific Officer, Rincon Pharmaceuticals, Inc.
Rincon’s AlgRx
platform utilizes the unique features of the plastid
(chloroplast) organelle of eukaryotic microalgae to
manufacture recombinant proteins. Recombinant proteins
expressed from genes introduced into the plastid genome
via homologous targeting are
tassembled with high fidelity into their native,
disulfide-bonded eukaryotic conformations. Once
synthesized, these proteins do not interact metabolically
with cellular components outside the organelle and thus
are functionally insulted allowing the accumulation of
typically difficult-to-express molecules. This strategy of
combining the most advantageous aspects of microbial
fermentation and eukaryotic cell culture has thus far
allowed us to produce a variety of therapeutic proteins
including a range of antibody formats from scFv’s to
complete human IgGs and chimeric receptor fusions.
9:35 Glyco-Engineering in
Moss and Production of Optimized Antibodies
Gilbert Gorr, Ph.D., Chief
Scientific Officer, greenovation Biotech GmbH
Glyco-engineered
mosses are suitable hosts for the production of
biopharmaceuticals. Long-term cultivation of mosses can be
performed in a robust, flexible and sustainable manner in
photobioreactors. Furthermore, moss-produced antibodies -
lacking fucose residues on its N-glycans - have been shown
to be superior when compared to its parental counterparts.
These data together with additional features like genetic
stability of transgenic moss strains will be presented and
discussed.
10:05 Coffee Break in the
Exhibit Hall
MANAGING
THE
MANUFACTURING PROCESS
10:50 The Business &
Science of Technology Transfer: A Case Study
Geoffrey Hodge, Ph.D., Vice
President, Process Development and Technology, Xcellerex,
Inc.
Technology
transfer is a complex process involving elements of
business and project management as well as good science.
This presentation will discuss the role of each of these
functional areas in order to ensure a clearly understood
technology transfer from client to CMO and a successful
scale-up of processes from bench to pilot and
manufacturing scale. Case studies and examples of
successes and potential pitfalls will be reviewed.
11:20 Creating a
State-of-the-Art Facility for Protein-Based Biopharmaceuticals Using Modular
Technology – Design Considerations, Project
Execution and Examples
Pär Almhem, President,
Pharmadule, Inc.
Bill Smith, President, Wes-Tech,
LLC, formerly VP of Engineering, Eli Lilly and Co.
Modular
technology has proven to be a viable and increasingly
popular alternative for designing and building facilities
for the production of biological drug products. This
presentation illustrates the benefits and challenges of
using modular construction, design considerations for a
biopharmaceutical production facility, and execution of
the modular project. It will include examples from
completed and ongoing projects.
11:50 End of Protein
Scale-Up & Manufacturing conference
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