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908 Devices Ask the Expert
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Linking mAb Product Quality Profile Changes to Your Bioprocess: Case Study of
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Key strategies for effective technology evaluationKey strategies for effective
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Post-pandemic dip: Panelists discuss CGT challengesPost-pandemic dip: Panelists
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Webcasts
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during a video interview at Biotech Week Boston (BWB).

Therapeutic ClassPost-pandemic dip: Panelists discuss CGT challenges

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as cell and gene therapies struggle with funding challenges and complex
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Aurigene’s chief commercial officer says his firm and other Indian CDMOs are “a
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Therapeutic ClassHow and why AstraZeneca’s oncology eyes turned to cell
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Cell therapies will play an increasingly important position in AstraZeneca’s
broad oncology pipeline, an SVP told delegates at Biotech Week Boston (BWB) last
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Upstream Processing

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Expression Platforms
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Downstream Processing

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LC-MS Detection of Host Cell Proteins: Antibody Affinity Extraction Sample
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Simplifying Downstream Processing: Innovative Solutions for Filtration and
Chromatography
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Manufacturing

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Jun 26, 2024

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Information Technology
Buffer Design for Biopharmaceutical Processes: An Online Tool for Designing and
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Information Technology
Keys to Successful Technology Transfer
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Industry: A Simulation-Based Study
Practical Applications of Process Capability Indices in the Biopharmaceutical
Industry: A Simulation-Based Study

Corrective and preventive actions
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Effectiveness of Corrective and Preventive Actions
Determining Sample Size for Demonstrating Zero Failures: Ensuring the
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Emerging Therapeutics
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Special Reports


Sponsored Content
Scaling Up mAb Production with a Platform Medium and Feed SystemScaling Up mAb
Production with a Platform Medium and Feed System

As the monoclonal-antibody (mAb) market continues to grow, it is becoming
increasingly important for pharmaceutical and biotech companies to accelerate
process development and establish a scalable manufacturing process capable of
achieving high titers and consistent product quality. Central to this is a cell
culture media and feed system that can provide the required nutrients for
optimal cell growth, viability, and function, as well as facilitate a seamless
transition from development to clinical and commercial manufacturing. However,
choosing an appropriate system can be a complex and time-consuming process,
often requiring the evaluation of multiple medium and feed options. Platform
systems, consisting of a medium and complementary feed developed for a specific
cell line and application, have emerged as a valuable option for developers to
help simplify selection and increase scale-up efficiency. To meet the need for
high-performance platform mAb manufacturing solutions, Thermo Fisher Scientific
has dev...

Sponsored Content
From Pipettes to Infusion Pumps: Volume Accuracy in Regulated Industries and Its
Critical ImpactFrom Pipettes to Infusion Pumps: Volume Accuracy in Regulated
Industries and Its Critical Impact

Precision in volume delivery is critically important for both the
biopharmaceutical and medical device industries. This special report discusses
how accurate volume measurement affects patient safety, product quality, and
regulatory compliance. Sartorius emphasizes the roles that infusion pumps,
laboratory pipettes, and quality control (QC) measures play in ensuring reliable
and reproducible results. Register or Login and hit Download Now to get the full
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Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs,
Process Development, and Manufacturing to Ensure Drug QualityNavigating
Biopharma Commercialization: The Interplay of Regulatory Affairs, Process
Development, and Manufacturing to Ensure Drug Quality

This webcast features: Yves Scheurer, manager, regulatory affairs, Lonza & Robin
Schumacher, late-stage expert, Lonza. In this webinar, join Lonza to explore the
essential alignment between regulatory affairs, process development, and
manufacturing in biopharmaceutical commercialization. Their expert speakers will
discuss how integrating these functions ensures drug quality, safety, efficacy,
and enables navigation of the complex regulatory landscape. This webinar draws
attention to the commercialization of microbial bioprocesses, though the
playbook that is presented can also be applied to other technologies in Lonza’s
portfolio. First, gain insight into regulatory guidelines, with a focus on
chemistry, manufacturing, and controls (CMC) documentation. Then, learn how
effective regulatory affairs support can expedite global compliance and
accelerate the commercial filing process. Finally, discover how regulatory
guidelines shape manufacturing processes, with practical insights on applying
quality ris...

Sponsored Content
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Product Quality Profile Changes to Your Bioprocess: Case Study of Dynamic
Glucose Level Control in CHO Process Improves Product Quality

This webcast features: Erin Redman, PhD, principal scientist, & Graziella Piras,
PhD , senior director of strategic marketing, life science, 908 Devices. Changes
made to the bioprocess can be linked to product quality attributes, but only if
there are frequent data points to show the development throughout the
bioprocess. Access to good product quality data at frequent timepoints from a
full bioprocess can be a tall order for the analytical department. In this
webinar, Erin Redman, PhD, principal scientist at 908 Devices, guides us through
an easy solution to acquire mAb quality attribute profiling (charge variant
profile, sequence identity, and glycosylation profile). Presented here is a
simple dilute-and-shoot analysis using ZipChip capillary electrophoresis
separation coupled to a high-resolution mass spectrometer. Then, Graziella
Piras, PhD, senior director of strategic marketing, life science, describes a
case study where a comparison of CHO fed-batch process runs with the usual daily
bolus gluc...

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Emerson white paper
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Sustainability in Life Sciences: Actionable Solutions for Improving Energy
Efficiency
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Empowering Modern Drug Product Development: Breakthroughs in High-Concentration
Formulations and Drug-Device Combination Products
Empowering Modern Drug Product Development: Breakthroughs in High-Concentration
Formulations and Drug-Device Combination Products

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Accelerating Cell Line Development with an Efficient, Combined Platform Approach
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Process Control) for CHO Fed-Batch Application
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Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated
Process Control) for CHO Fed-Batch Application
Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated
Process Control) for CHO Fed-Batch Application



High Productivity and Process Economy in GxP Applications with the Octet™
Platform
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Platform
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Videos

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