Full Conference Details Inside

1:40
1:45
2:15
2:45
Thursday, October 11, 2012 (continued)
Cell Culture Recovery & Purification
Effect of the Cell Culture Environment
on Product Quality
Chairperson’s Remarks
Gary J. Welch, Director, Process Science,
Abbott Bioresearch Center
Engineering a Glycosylated Full-Length IgG
Antibody: Bypassing Glycosylation, Developing
Novel Effector Functions and Enhancing Potency
UNPUBLISHED
DATA
In IgG molecules, removal of the glycan at Asn297 abolishes
binding to FcγRs and effector functions mediated by
leukocytes. We have developed a robust screening platform
for engineering aglycosylated full length IgG with various FcγRs
selectivity. A set of Fc engineered versions of aglycosylated antibody
with unique or improved effector functions have been generated and
will be discussed.
Sang Taek Jung, Ph.D., Research Associate, Staff Scientist,
Department of Chemical Engineering,
The University of Texas at Austin
Optimizing Productivity and Product Quality
of a Commercial Cell Culture Process for
a High Demand mAb Product
CASE STUDY
UNPUBLISHED
DATA
This case study will highlight challenges and key
achievements in developing a high titer cell culture
process under short timelines. Initial platform process
bioreactor studies yielded unexpectedly low titers, but a two-fold
improvement was obtained through mimicking the uncontrolled
pH profile observed in shake flasks. Several product quality
challenges were also addressed, including mitigating sequence
variants and modulating charge variants.
Melissa Mun, M.S., Engineer II, Late Stage Cell Culture,
Genentech, Inc.
A Scale-Down Model Qualification Case Study
for QbD Cell Culture Process Characterization
Cell culture process characterization studies for a protein
production process were performed using a scale-down
model. A Quality by Design (QbD) approach was taken
in order to improve overall process understanding, with the final
outcome being both univariate and multivariate acceptable ranges
for each parameter tested. However, applicability of these study
results to the manufacturing scale depends on the validity of
the scale-down models that have been used. In this particularly
complex case study, both small and pilot scale models were
qualified. Evaluation of some product quality attributes required
further downstream processing through scale-down purification
models. As a result, qualification of the cell culture model
ultimately relies on qualification with the purification scale-down
model as well. The way the models were applied depends both
on the product quality attribute being evaluated and the unitoperation
being characterized. Our scale-down model qualification
approach will be presented and challenges related to applying
scale-down results to manufacturing scale will be discussed.
Angela Meier, B.Sc., Engineer I, Late Stage Cell Culture Process
Development, Genentech, Inc.
CASE STUDY
UNPUBLISHED
DATA
Streamlining Downstream Processing to
Improve Cost and Time to Clinic
Chairperson’s Remarks
Uwe Gottschalk, Ph.D., Vice President, Purification Technology,
Sartorius Stedim Biotech, Germany
Manufacturing High Concentration mAb
Formulations using Ultrafiltration / Diafiltration
Monoclonal antibody therapeutics have traditionally been
delivered using intravenous (IV) administration. Companies are
now increasingly developing high concentration formulations of
monoclonal antibody therapeutics to allow subcutaneous (SC)
administration. New UF/DF systems can be designed to minimize
hold-up volume and enhance mixing in the recycle tank, allowing for
formulation at high concentrations. Utilizing legacy UF/DF systems
for SC formulation can lead to many challenges. Challenges will be
discussed, and a case study will be presented on implementation
of high concentration formulation on a UF/DF commercial scale
system not originally designed for SC formulation.
Stephen Hohwald, Engineer, Purification Development,
Genentech, Inc.
Exploiting Online Refractometry for Improved
Ultrafiltration Development and Manufacturing
Engineering Operation Control
CASE STUDY
CASE STUDY
UNPUBLISHED
DATA
Accurate targeting of high protein concentration Drug
Product formulations has become a challenge within
biological manufacturing arenas via traditional absorbance methods
and process control techniques. The work presented here will
demonstrate the application of inline refractometry to provide
real-time concentration measurements for enhanced ultrafiltration
process monitoring and control. Data will be presented from
pilot and clinical manufacturing systems. In summary, inline
probes demonstrated >96% concentration accuracy up to 150g/L.
Additional applications for inline refractometry will be discussed for
Biologics processing.
Nickolas Brings, MBA, Process Engineer,
Global Engineering and Facilities, Biogen Idec
Robustness and Efficiency of Two Column
Purification Process
Timothy Iskra, M.S., Principal Scientist, Pfizer Inc.
UNPUBLISHED
DATA
Vaccine and Complex Biologics
Development and Production
Chairperson’s Remarks
Hari Pujar, Ph.D., Director, External Process Development,
Merck & Co., Inc.
QbD for Vaccines: From Regulatory Relief to
Design for Manufacturing
Due to the complexity of vaccines manufacturers are working
together with regulators to appropriately apply QbD approaches
to vaccine development and control. Many companies, however,
have realized the value of these enhanced methods in developing
a robust manufacturing process and in helping to ensure product
quality through a carefully established control strategy. This talk
will highlight QbD approaches which help assure an ample supply
of quality vaccines to the public.
Timothy Schofield, Managing Director, Arlenda USA
Implementing Vaccine QbD
Robert Repetto, M.S., MBA., Research Fellow, External Affairs,
Pfizer BioTherapeutics Pharmaceutical Sciences;
Chair, PDA Single-Use System Task Force
Presentation TBA
17 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com • www.IBCLifeSciences.com/BPI