Biopharma Development

Impact of freezing and thawing on DS solutions in bottles
Development of in-house boundary element model (BEM) for modeling and simulation of lyophilization process with constructed design space in a vial
Non-clinical perspectives of developing complex biosimilars – GNT904 case study
Degradation of polysorbates 20 and 80 catalysed by histidine chloride buffer
Indirect proofs that HCPs are degrading polysorbates: GNT904A1 case
Protein formulations containing polysorbates: Are metal chelators needed at all?
The story of Ziextenzo® – Never give up!
WHO Prequalification of Rixathon ® – A success story
The epic treasure hunt for host cell proteins towards stable polysorbate
GP2015 WCB process optimization to obtain a larger cell bank
The effect of bioprocess conditions, designed to optimize biosimilar product quality, on CHO fed-batch productivity
Comparison of bioprocesses with CHO cell line in different bioreactors
Structure / function study: Effect of aglycosylation level in nivolumab (IgG4) on Fcγ receptor binding
Modeling of downscale model design and parameters for filter validation
Justification of regional sample size: SOK583A1 (aflibercept biosimilar) experience with PMDA
IdeS-SEC-MS - Effortless Screening of Glycovariants in Biosimilar Early Development
A tool for viscosity reduction activity prediction
Development and implementation of HTP approach in high protein concentration liquid formulation development
Evaluation and development of two analytical methods for high-throughput determination of free amino acids in cell culture samples for bioprocess development
Optimization of the cryopreservation of Chinese Hamster Ovary cells
Designing scalable ultrafiltration/diafiltration process of monoclonal antibodies via mathematical modeling
Blast freezing: visual evaluation of the ice growth direction in a plastic bottle
The Importance of Countering Biosimilar Disparagement and Misinformation
New In-vitro model for absorption prediction of subcutaneous administered proteins
Impact of saline and human serum solutions on inherent protein-silicone visible particles observed in GP2503 (pertuzumab)
Reimagining PSUR strategy: a Biopharma initiative from concept to reality
Ipilimumab biosimilar program implements new Tailored Preclinical strategy, reduces development risk and avoids animal testing
The Path Towards a Tailored Clinical Biosimilar Development
Characterization of an unusual N-glycan variant in nivolumab reference product batches
Impact of the COVID-19 pandemic on clinical trials: Serology testing framework
Test kits for visual inspection – a cross-functional collaboration between TRD and NTO
From scientific suspicion of hematologic malignancies related to Filgrastim biosimilar (Zarzio), to a potential happy ending story
Automation of peptide mapping method facilitating the process development of SOK583A1
Mass spectrometry- a powerful tool to support root cause identification for visible particle formation in GP2503 drug product samples
Native MS analysis of biomolecules
Assessment of protein conformations by Analytical Cascade of Enzymes (ACE)
Utilizing proteomic and pharmacogenetic research to understand unpredictable immune responses to adalimumab and their impact on pharmacokinetics
Characterization of complex disulfide linkages in Biopharmaceuticals by coupling electrochemical reduction and LC/MS analysis

Impact of freezing and thawing on DS solutions in bottles

Development of in-house boundary element model (BEM) for modeling and simulation of lyophilization process with constructed design space in a vial

Non-clinical perspectives of developing complex biosimilars – GNT904 case study

Degradation of polysorbates 20 and 80 catalysed by histidine chloride buffer

Indirect proofs that HCPs are degrading polysorbates: GNT904A1 case

Protein formulations containing polysorbates: Are metal chelators needed at all?

The story of Ziextenzo® – Never give up!

WHO Prequalification of Rixathon ® – A success story

The epic treasure hunt for host cell proteins towards stable polysorbate

GP2015 WCB process optimization to obtain a larger cell bank

The effect of bioprocess conditions, designed to optimize biosimilar product quality, on CHO fed-batch productivity

Comparison of bioprocesses with CHO cell line in different bioreactors

Structure / function study: Effect of aglycosylation level in nivolumab (IgG4) on Fcγ receptor binding

Modeling of downscale model design and parameters for filter validation

Justification of regional sample size: SOK583A1 (aflibercept biosimilar) experience with PMDA

IdeS-SEC-MS - Effortless Screening of Glycovariants in Biosimilar Early Development

A tool for viscosity reduction activity prediction

Development and implementation of HTP approach in high protein concentration liquid formulation development

Evaluation and development of two analytical methods for high-throughput determination of free amino acids in cell culture samples for bioprocess development

Optimization of the cryopreservation of Chinese Hamster Ovary cells

Designing scalable ultrafiltration/diafiltration process of monoclonal antibodies via mathematical modeling

Blast freezing: visual evaluation of the ice growth direction in a plastic bottle

The Importance of Countering Biosimilar Disparagement and Misinformation

New In-vitro model for absorption prediction of subcutaneous administered proteins

Impact of saline and human serum solutions on inherent protein-silicone visible particles observed in GP2503 (pertuzumab)

Reimagining PSUR strategy: a Biopharma initiative from concept to reality

Ipilimumab biosimilar program implements new Tailored Preclinical strategy, reduces development risk and avoids animal testing

The Path Towards a Tailored Clinical Biosimilar Development

Characterization of an unusual N-glycan variant in nivolumab reference product batches

Impact of the COVID-19 pandemic on clinical trials: Serology testing framework

Test kits for visual inspection – a cross-functional collaboration between TRD and NTO

From scientific suspicion of hematologic malignancies related to Filgrastim biosimilar (Zarzio), to a potential happy ending story

Automation of peptide mapping method facilitating the process development of SOK583A1

Mass spectrometry- a powerful tool to support root cause identification for visible particle formation in GP2503 drug product samples

Native MS analysis of biomolecules

Assessment of protein conformations by Analytical Cascade of Enzymes (ACE)

Utilizing proteomic and pharmacogenetic research to understand unpredictable immune responses to adalimumab and their impact on pharmacokinetics

Characterization of complex disulfide linkages in Biopharmaceuticals by coupling electrochemical reduction and LC/MS analysis