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Reza Nejadnik

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Coriolis Pharma appoints formulation expert Prof. Dr. Reza Nejadnik to its Scientific Advisory Board

With the appointment of Reza Nejadnik to its scientific advisory board, Coriolis again strengthens its scientific expertise particularly in the area of protein formulation and analytics.

Bruce Kerwin

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Press Release: Bruce Kerwin

Coriolis Pharma appoints formulation and drug development expert Bruce Kerwin to scientific advisory board

Constanze Helbig - outstanding early career scientist

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Constanze Helbig honored by JPharmSci® as Outstanding Early Career Scientist

Constanze Helbig, Group Leader Scientific Research at Coriolis, is one of the outstanding early career scientists, honored by JPharmSci® for their most original and significant scientific findings.

We restructured our entire website

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We restructured our entire website

More content, more services, more Coriolis! Enjoy exploring our new pages...

Coriolis Pharma Invests in Growth by Creating a New Campus in Martinsried-Munich

News

Coriolis Pharma Invests in Growth by Creating a New Campus in Martinsried-Munich

Coriolis Pharma is substantially expanding its current headquarters with additional facilities to form a new Campus

Coriolis Employee Establishes Organization “Save Lives in Ukraine”

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Coriolis Employee Establishes Organization “Save Lives in Ukraine”

Protect the Virus! - Coriolis Experts Publish Article About Virus Formulation.

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Protect the Virus!

Coriolis experts around Gideon Kersten publish opinion article about virus formulation in "The Medicine Maker"

Coriolis Pharma Appoints Silvia Steyrer-Gruber as New Chief Executive Officer

News

Coriolis Pharma Appoints Silvia Steyrer-Gruber as New Chief Executive Officer

Coriolis Pharma Appoints Silvia Steyrer-Gruber as New Chief Executive Officer

Journal of Pharmaceutical Science Publishes Special Issue in Memory of Wim Jiskoot

News

Journal of Pharmaceutical Science Publishes Special Issue in Memory of Wim Jiskoot

Coriolis contributed several publications to honor a great colleague and friend.

Coriolis Pharma and U-Medico Announce a Strategic Alliance

News

Coriolis Pharma and U-Medico Announce a Strategic Alliance

Coriolis Pharma (Martinsried, Germany) and U-Medico (Osaka, Japan) will join forces to provide science-driven and innovative formulation development services for clients worldwide.

All news and updates

Meet us at World Vaccine Congress 2023 in Washington

Join us at World Vaccine Congress 2023 in Washington. Meet our experts Evelyn Eggenstein and Anna Gebhardt at booth 1104.

Coriolis Pharma appoints formulation expert Prof. Dr. Reza Nejadnik to its Scientific Advisory Board

With the appointment of Reza Nejadnik to its scientific advisory board, Coriolis again strengthens its scientific expertise particularly in the area of protein formulation and analytics.

Meet us at BioEurope Spring 2023 in Basel, Switzerland

Chat with our experts at the Bavarian joint booth at BioEurope Spring in Basel, Switzerland from 20 to 22 March, 2023.

Press Release: Bruce Kerwin

Coriolis Pharma appoints formulation and drug development expert Bruce Kerwin to scientific advisory board

4th Annual Gene Therapy Analytical Development

Don't miss our talk "Determination of cQAs of AAV-preparations by orthogonal approaches", held by Dr. Klaus Richter and meet our experts Dr. Evelyn Eggenstein and Dr. Jörg Müller at our booth.

Constanze Helbig honored by JPharmSci® as Outstanding Early Career Scientist

Constanze Helbig, Group Leader Scientific Research at Coriolis, is one of the outstanding early career scientists, honored by JPharmSci® for their most original and significant scientific findings.

Meet us at the BioProduction on the CPhI Frankfurt

Visit our booth 91J37 in hall 9.1 and speak to our experts Dr. Jörg Müller, Dr. Cora Keil & Dr. Matthias Lucke in person

Coriolis participates at the Global Bioprocessing Summit in Berlin

Visit our Coriolis Booth and speak to one of our experts in person

Coriolis Experts Speak at PDA Biomanufacturing Conference in Amsterdam

Listen to the Coriolis talk about "Protein Stability in the Freeze Concentrated Solution" and meet Matthias Lucke at our exhibition booth

2022/08/30 - 16:00

Maximum Quality at Maximum Speed - A Novel Approach to Freeze-Drying Cycle Design

Our scientific advisor Prof. Friess and scientific expert Dr. Vanbillemont introduce a novel freeze-drying cycle design approach recently established at Coriolis.

Coriolis Experts Speak at Colorado Protein Stability Conference

Listen to exiting talks by Coriolis CTO and our scientific advisors, and visit us at the Coriolis booth

Coriolis PhD Student Presents Poster at the CRYO2022 Event in Dublin

Alexandra Roesch received a Student Travel Grant to present her latest research data on the cryoprotection of Jurkat cells

High concentration protein formulation – challenges and solutions

By Dr. Alexandra Kafka, Dr. Andreas Stelzl, Dr. Daniel Weinbuch and Dr. Andrea Hawe

We restructured our entire website

More content, more services, more Coriolis! Enjoy exploring our new pages...

AI Improves Quality Control of Cell- and Gene Therapy Products

A glance into the future by Grabarek et al.

Meet us at the PDA Advanced Therapy Medicinal Products Conference

Visit our exhibition booth and talk to our experts face-to-face

Coriolis Pharma Invests in Growth by Creating a New Campus in Martinsried-Munich

Coriolis Pharma is substantially expanding its current headquarters with additional facilities to form a new Campus

Coriolis Employee Establishes Organization “Save Lives in Ukraine”

Protect the Virus!

Coriolis experts around Gideon Kersten publish opinion article about virus formulation in "The Medicine Maker"

Coriolis participates at the AAPS National Biotechnology Conference

Meet our CSO Dr. Andrea Hawe and join her talk about "Surfactant Degradation: The Closer You Look The More You Learn"

Coriolis Pharma Appoints Silvia Steyrer-Gruber as New Chief Executive Officer

Coriolis Pharma Appoints Silvia Steyrer-Gruber as New Chief Executive Officer

Meet us at the PEGS Boston Conference

Meet our team at the Coriolis booth or visit us at the poster session

Coriolis expert speaks at EIP Symposium in Portugal

Dr. Andrea Hawe will speak about the relevance of particle analysis for immunogenicity in biopharmaceuticals

Journal of Pharmaceutical Science Publishes Special Issue in Memory of Wim Jiskoot

Coriolis contributed several publications to honor a great colleague and friend.

Meet us at the PDA Visual Inspection Forum in Berlin

Our expert Dr. Jörg Müller is very looking forward to welcome you at the Coriolis booth!

Coriolis Pharma and U-Medico Announce a Strategic Alliance

Coriolis Pharma (Martinsried, Germany) and U-Medico (Osaka, Japan) will join forces to provide science-driven and innovative formulation development services for clients worldwide.

Prof. Dr. Paolo Arosio joins our Scientific Advisory Board

We welcome Prof. Dr. Paolo Arosio as a new Scientific Advisory Board Member and expert in protein aggregation and biophysical properties of biologics.

Coriolis Pharma opens new ATMP formulation development facilities

Coriolis’ new ATMP facilities will meet the growing demand for formulation development and analytical characterization for ATMPs up to BSL2/S2 level and increase Coriolis’ capabilities significantly

Prof. Dr. Hristo Svilenov joins our Scientific Advisory Board

We welcome Prof. Dr. Hristo Svilenov as a new Scientific Advisory Board Member and expert in formulation development of biotherapeutics

Coriolis spreads the Christmas spirit

Following our yearly tradition, we are donated 23,000 € to several charity organizations, which were selected by our employees.

2021/12/14 - 16:00

Particle Analysis in Biopharmaceuticals – an Overview from Protein Particles to Living Cells

Our CTO Dr. Tim Menzen will describe how to reliably size, quantify, differentiate and identify particles in the nanometer, micrometer and visible size range.

Coriolis AUC Expert gives Talk at the Gene and Cell Therapy Conference

Dr. Klaus Richter will speak about "Assessing Critical Quality Attributes of viral vectors for gene therapy" at conference in Munich.

Meet us at the Festival of Biologics in Basel

Fund us at booth 51 and arrange your face-to-face meeting with our experts on site.

A Sunny Sailing Trip at the Starnberg Lake

Coriolis employees enjoyed a wonderful sailing day with the Coriolis-sponsored GFK Team on the H-boat "Kiaora"

Meet us at the PEGS Europe Summit in Barcelona

Find us at booth 210 and listen to our Scientific Advisor Prof. Kersten's talk about "mRNA-Based COVID-19 Vaccines"

2021/09/21 - 16:00

Polysorbate - an excellent stabilizer with a dark side

Our CSO Dr. Andrea Hawe puts a spotlight on polysorbate, an important stabilizer for biopharmaceuticals. Based on her own research, she outlines critical degradation pathways and explains analytical strategies to ensure drug product stability and meet current regulatory expectations.

Coriolis supports live discussion forum BioM Science & Health

The BioM Forum is an interdisciplinary discussion platform making scientific viewpoints available to the public. Coriolis is gold sponsors of the next session about mRNA and gene therapy.

Prof. Dr. Susumu Uchiyama joins Scientific Advisory Board of Coriolis

We welcome Prof. Dr. Susumu Uchiyama as a new Scientific Advisory Board Member and expert for viral vectors for gene therapy.

Coriolis-sponsored sailing team happy with 2021 world cup race

The GFK racing team achieved a fantastic 10th place at the H-boat world cup race in Denmark.

In Memoriam Prof. Dr. Wim Jiskoot (1961 – 2021), Scientific Advisor of Coriolis

We will remember Wim as the openminded, brilliant, and honest person, who stayed positive even after a devastating diagnosis. Our thoughts are with his loved ones, in particular Karin, Julia and Carles.

Coriolis Scientist contributes to "Bioanalytik" by Lottspeich

Our AUC expert Dr. Klaus Richter co-authors chapter about protein interactions in Lottspeich's standard reference book "Bioanalytik"

Coriolis helps victims of flood catastrophe

Coriolis supports the emergency aid by Germany's Relief Coalition with donation. Our thoughts are with those who lost relatives and friends.

Prof. Dr. Olivia Merkel joins our Scientific Advisory Board

We welcome Prof. Dr. Olivia Merkel as a new Scientific Advisory Board Member and expert for targeted mRNA delivery

2021/06/29 - 16:00

Nucleic acid-based medicinal products: Formulation considerations

Our scientific advisory board member Prof. Dr. Wim Jiskoot discusses how the stability of nucleic acid-based medicinal products, including gene-therapy products and genetic vaccines, can be improved by means of formulation development.

Coriolis Supports Local Sailing Team on „Road to Sweden 2023” Project

The ambitious goal of the GFK sailing team is a top ten rank in the world championship in 2023.

Coriolis Pharma expands its ATMP development facilities

Constructions of new facilities for ATMP formulation development up to biosafety level S2 are in progress and operations are expected to start by Q4 2021

Prof. Ernst Wagner joins Coriolis Pharma’s Scientific Advisory Board as expert for nucleic acid therapeutics

We welcome Prof. Dr. Ernst Wagner as new Scientific Advisory Board Member and expert for nucleic acid therapeutics

Coriolis CSO and Scientific Advisor give key talks at international conference

Dr. Hawe & Prof. Kersten are invited speakers at the 12th Annual Biologics Formulation & Drug Delivery Forum

Gordon Research Conference invites Coriolis CTO as session chair

Dr. Tim Menzen will chair the session "Properties of Biologics Impacting Safety and Efficacy"

Coriolis Scientist receives PhD Award for Thesis about Protein Aggregation

We congratulate Dr. Lorenzo Gentiluomo for his great achievement!

Prof. Dr. Gideon Kersten joins Scientific Advisory Board of Coriolis

Prof. Kersten brings 35+ years of experience in vaccine development with a focus on characterization & formulation.

Coriolis Scientist wins Prize for PhD Thesis about Freeze-drying

We congratulate Dr. Brecht Vanbillemont for his great achievement!

Coriolis Group Leader gives Talk at ThermoFisher CAD Symoposium

Dr. Georg Schuster discusses the investigation of polysorbate degradation.

Lyophilization Process Development at Light-Speed

Novel approach obtains optimal process parameters with only one experimental run

Coriolis Scientist speaks at virtual CASSS Higher Order Structure Event

Dr. Constanze Helbig will talk about high-throughput analysis of subvisible particles

Coriolis AUC Expert gives Talk at the CHI Gene & Cell Therapy Analytics Summit

Dr. Klaus Richter speaks about 'Assessing Critical Quality Attributes of Viral Vectors for Gene Therapy'

Coriolis Advisor is Keynote Speaker at AAPS National Biotechnology Conference

Prof. Dr. Wim Jiskoot will outline 'Formulation Considerations for Nucleic-Acid-Based Medicinal Products'

Coriolis CSO invited to speak at IFPAC 2021 Event

Dr. Andrea Hawe joins FDA-hosted session about particles in biologic drug products

Coriolis CSO, CTO and advisor speak at PepTalk 2021

With talks and panel discussions about polysorbate analysis and AI-powered particle characterization

Coriolis' TOP 5 publications in 2020

We conclude our scientific year by nominating our TOP 5 publications of 2020

Artificial intelligence improves quality control of cell- and gene therapy products

See the Big Picture - Research Summary

Coriolis Website Now Cookie-Free by Default

Another item on our list of measures that we take to keep your personal and project-related data safe and secure.

2020/11/05 - 16:00

Nanoparticulate Impurities in Excipients - A Threat to Protein Stability

Dr. Andrea Hawe and Dr. Daniel Weinbuch give insights into their research on nanoparticulate impurities in pharmaceutical-grade sucrose.

Coriolis participates at Festival of Biologics

Listen to the talk by Coriolis CTO Dr. Tim Menzen and meet us at our exhibition booth.

Webinar: Nanoparticulate Impurities in Excipients - A Threat to Protein Stability

Merck Life Science hosts Webinar with Coriolis Scientists

Coriolis Expert Gives Talk About the Application of Analytical Ultracentrifugation for Biopharmaceuticals

Dr. Klaus Richter speaks at the 11th Biologics Formulation Development and Drug Delivery Event

Coriolis participates at the PDA Visual Inspection Forum

Visit our virtual exhibition booth and meet Dr. Jörg Müller online.

Study by Coriolis proposes new degradation mechanism for polysorbate

Micelles may function as nanoscale reaction vessels for polysorbate oxidation

Coriolis CSO gives talk about analytical techniques for polysorbate characterization

Listen to Dr. Andrea Hawe's talk at Thermo Scientific's virtual Biopharmaceutical Symposium

Modulating Scanning Fluorimetry (MSF): Unlocking a thermal protein-stability parameter for early drug development

At what temperature does protein unfolding become irreversible? - This new method only needs a few µl of sample to give you the answer.

Coriolis participates at the BioProcess International Conference

Visit our virtual booth and meet Dr. Matthias Lucke and Dr. Jörg Müller online.

Coriolis participates at PDA Europe's virtual ATMP conference

Visit our virtual booth and listen to the talk by our CTO

Coriolis participates in Covid-19 Virtual Partnering Event

Meet Dr. Stefan Heindl at the digital event from 4. - 6. May

Coriolis CTO speaks at CASSS symposium in Lisbon

Meet Dr. Tim Menzen and listen to his talk about a novel polysorbate quantification assay

Coriolis will be present at Freeze-Drying Summit in Vienna

Meet our lyophilization expert Matthias Wurm at the event

Coriolis advisor gives talk at LAII Conference in La Jolla

Prof. Dr. Wim Jiskoot will discuss immunogenicity concerns for long-acting injectables and implantables

Coriolis CSO discusses excipients for parenterals at IPEC Forum

Meet Dr. Andrea Hawe and other pharmaceutical excipient experts in Aix-en-Provence, France

Coriolis (co-)authored 14 scientific publications in 2019

We thank all authors and collaborators for this achievement

Coriolis celebrates “two giants”: Prof. Carpenter and Prof. Randolph

Scientists and advisors of Coriolis contribute 16 papers to J Pharm Sci issue dedicated to John and Ted

Coriolis participates at PepTalk event in San Diego

Listen to talks by our scientific advisor Prof. Dr. Winter and our AUC expert Dr. Richter

Coriolis spreads the Christmas spirit

After an exciting and eventful year 2019, the spirit of the Christmas holidays reminds us to take a step back from the daily routine and look at the bigger picture.

Coriolis scientific advisor to give Keynote Presentation at PEGS Europe

Prof. Dr. Wim Jiskoot will explain the ”size-gap” in particle analysis and how to close it

Coriolis co-organizes workshop on protein stability

Engage with many notable scientists during the APV Workshop in Munich

Coriolis scientific advisor speaks at MIBio in Cambridge, UK

Listen to Prof. Dr. Wim Jiskoot explaining the link between aggregate size and protein immunogenicity

Engage with Coriolis at Partnering Event in Hamburg

Visit the Coriolis booth and meet Dr. Jörg Müller at the BioEurope conference

Speed-Date Coriolis at the TUM Career Days

Our HR-Manager and scientific employees look forward meeting you

Coriolis participates with three talks at AAPS PharmSci 360 event

Our scientific advisor Prof. Dr. Wim Jiskoot, our CTO Dr. Tim Menzen and our lyophilization expert Dr. Matthias Lucke will give talks at the AAPS PharmSci 360.

Coriolis CSO will talk at PDA workshop in Sweden

Listen to Dr. Andrea Hawe’s talk about the importance of polysorbate in pre-filled syringes

Get to know us at the InPharma Symposium in Munich

Dr. Klaus Richter will introduce Coriolis and talk about transitioning from academia to industry.

Coriolis will be present at PDA Europe event in Berlin

Meet us at the Pharmaceutical Freeze-Drying Technology Conference

Coriolis CTO present at conference in Munich

Meet Dr. Tim Menzen at the Drug Delivery & Formulation Summit

Coriolis scientist speaks at AATP Conference in Paris

Dr. Constanze Helbig will share insight into the orthogonal analysis of aggregates and particles in biopharmaceuticals

Coriolis participates at the Nordic Life Science (NLS) Days

Meet us at the Coriolis booth and listen to the talk of Dr. Michael Wiggenhorn

Coriolis participates at the BioManufacturing Conference Europe

Dr. Matthias Lucke will present an interesting application of heat-flux sensors during lyophilization.

Coriolis CTO and scientific advisors speak at seminar in Tokyo

Dr. Tim Menzen, Prof. Dr. Gerhard Winter and Prof. Dr. Wolfgang Frieß are invited speakers at the Biopharma Seminar, October 8th 2019, Japan, Tokyo.

Coriolis scientists give talks at international conference in Boston

Dr. Constanze Helbig and Dr. Wendelin Kranz are invited speakers at THE BIOPROCESSING SUMMIT, August 13-17, 2019, Boston, MA.

Sponsoring the 2019 Colorado Protein Stability Conference

Coriolis Pharma is proud to be sponsor of the “2019 Colorado Protein Stability Conference: 25th Anniversary”.

PhD Student at Coriolis among Grant Awardees

Congratulations to Adam Grabarek for receiving the CASSS Travel Grant

Coriolis releases commentary to European Pharmacopoeia

Coriolis has written a comprehensive commentary to the Ph.Eur. Chapter 2.2.1. "Clarity and degree of opalescence of liquids"

Coriolis has a new website!

After months of hard work, we are proud to present our new website.

Introduction into Formulation Development of Biologics

Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates.

Orchestrating immune responses: How size, shape and rigidity affect the immunogenicity of particulate vaccines.

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

Design of freeze-drying cycles: The determination of heat transfer coefficient

Non-GMP manufacturing of liquid drug products

Nanoparticulate Impurities Isolated from Pharmaceutical-Grade Sucrose Are a Potential Threat to Protein Stability

Online fluorescent dye detection method for the characterization of immunoglobulin G aggregation

Label-free, flow-imaging methods for determination of cell concentration and viability.

Modulated Scanning Fluorimetry Can Quickly Assess Thermal Protein Unfolding Reversibility in Microvolume Samples

Imaging Flow Cytometry for Sizing and Counting of Subvisible Particles in Biotherapeutics

Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations.

Shaken, not stirred: mechanical stress testing of an IgG1 antibody.

Submicron size particles of a murine monoclonal antibody are more immunogenic than oligomers or micron size particles upon subcutaneous administration in mice.

Micelle driven oxidation mechanism and novel oxidation markers for different grades of polysorbate 20 and 80

Utility of three flow imaging microscopy instruments for image analysis in evaluating four types of subvisible particle in biopharmaceuticals

Measurement of the average mass of proteins adsorbed to a nanoparticle by using a suspended microchannel resonator

N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins.

Formulation of biologicals including biopharmaceutical considerations.

Immunological Evaluation In Vitro of Nanoparticulate Impurities Isolated From Pharmaceutical-Grade Sucrose

Particle characterization

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations.

Silicone Oil-Free Polymer Syringes for the Storage of Therapeutic Proteins.

Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development

Combining Unfolding Reversibility Studies and Molecular Dynamics Simulations to Select Aggregation-Resistant Antibodies

Quality under GMP and R&D

Light obscuration measurements of highly viscous solutions: sample pressurization overcomes underestimation of subvisible particle counts.

Progress in formulation development and sterilisation of freeze-dried oligodeoxynucleotide-loaded gelatine nanoparticles.

Development of HSA-free formulations for a hydrophobic cytokine with improved stability.

Addressing the Cold Reality of mRNA Vaccine Stability.

Higher order structure analysis

MFI and RMM - complementary methods to quantitatively differentiate protein particles and silicone oil droplets.

Long-term release and stability of pharmaceutical proteins delivered from solid lipid implants.

Structural Analysis of Proteins in Dried Matrices

Forced degradation of cell-based medicinal products guided by flow imaging microscopy: explorative studies with Jurkat cells

Lyophilization process development

Interaction of meso-tetrakis (4-N-methylpyridyl) porphyrin in its free base and as a Zn(II) derivative with large unilamellar phospholipid vesicles.

Influence of hydroxypropyl-Beta-cyclodextrin on the stability of dilute and highly concentrated immunoglobulin g formulations.

Capillary electrophoresis-mass spectrometry using noncovalently coated capillaries for the analysis of biopharmaceuticals.

Towards quantification and differentiation of protein aggregates and silicone oil droplets in the low micrometer and submicrometer size range by using oil-immersion flow imaging microscopy and convolutional neural networks

Lyophilizate analytics

Asymmetrical flow field-flow fractionation method for the analysis of submicron protein aggregates.

Application of different analytical methods for the characterization of non-spherical micro- and nanoparticles.

New method to produce equine antirabies immunoglobulin F(ab')₂ fragments from crude plasma in high quality and yield.

Ongoing challenges to develop high concentration monoclonal antibody-based formulations for subcutaneous administration: Quo Vadis?

Analysis of subvisible particles and aggregates in GMP compliance

Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Forced degradation of therapeutic proteins.

The role of polysorbate 80 and HPβCD at the air-water interface of IgG solutions.

Novel high-throughput assay for polysorbate quantification in biopharmaceutical products by using the fluorescent dye DiI.

Particles in Biopharmaceutical Formulations, Part 2

In-use stability studies

Does controlled nucleation impact the properties and stability of lyophilized monoclonal antibody formulations?

Comparison of analytical methods to detect instability of etanercept during thermal stress testing.

Fate of Multimeric Oligomers, Submicron, and Micron Size Aggregates of Monoclonal Antibodies Upon Subcutaneous Injection in Mice.

Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation.

Assessing the Aggregation Propensity of Single-Domain Antibodies upon Heat-Denaturation Employing the ΔTm Shift

Scientific excellence

Scalable organic solvent free supercritical fluid spray drying process for producing dry protein formulations

Fluorescent molecular rotors as dyes to characterize polysorbate-containing IgG formulations.

A comprehensive evaluation of nanoparticle tracking analysis (NanoSight) for characterization of proteinaceous submicron particles.

Trends on Analytical Characterization of Polysorbates and Their Degradation Products in Biopharmaceutical Formulations.

Addressing the challenges of purification and quality control in gene therapy

Non-GMP manufacturing of lyophilized drug products

Chemical and Biophysical Characteristics of Monoclonal Antibody Solutions Containing Aggregates Formed during Metal Catalyzed Oxidation

Extrinsic fluorescent dyes as tools for protein characterization.

Postproduction handling and administration of protein pharmaceuticals and potential instability issues.

Heat Flux Sensor to Create a Design Space for Freeze-Drying Development

Combining Machine Learning and Backgrounded Membrane Imaging

Cationic liposomes loaded with a synthetic long peptide and poly(I:C): a defined adjuvanted vaccine for induction of antigen-specific T cell cytotoxicity

The freezing step in lyophilization

Hyaluronan-based dissolving microneedles with high antigen content for intradermal vaccination

Advanced Therapy Medicinal Products: What's in a Name?

SV-AUC as a stability-indicating method for the characterization of mRNA-LNPs

Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics.

Test models for the evaluation of immunogenicity of protein aggregates.

Immunogenicity of therapeutic proteins.

Oil-Immersion Flow Imaging Microscopy for Quantification and Morphological Characterization of Submicron Particles in Biopharmaceuticals

Lyophilized Drug Product Cake Appearance: What Is Acceptable?

Expanding Bedside Filtration-A Powerful Tool to Protect Patients From Protein Aggregates.

Analytical approaches to assess the degradation of therapeutic proteins

Comparison of Different Liquid Chromatography-Based Purification Strategies for Adeno-Associated Virus Vectors

Surfactant characterization

Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods.

Isothermal chemical denaturation as a complementary tool to overcome limitations of thermal DSF

Towards heat-stable oxytocin formulations: analysis of degradation kinetics and identification of degradation products.

The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines

Chemical changes

How subvisible particles become invisible-relevance of the refractive index for protein particle analysis.

Needle-Free Injection of Vesicular Phospholipid Gels-A Novel Approach to Overcome an Administration Hurdle for Semisolid Depot Systems.

Aggregation and Immunogenicity of Therapeutic Proteins

Comparison of Syringes With Intravitreal Anti-VEGF Drugs: Particle Burden and Protein Aggregates in Brolucizumab, Aflibercept and Bevacizumab

Functional assays

Non-ionic Gd-based MRI contrast agents are optimal for encapsulation into phosphatidyldiglycerol-based thermosensitive liposomes.

Can controlled ice nucleation improve freeze-drying of highly-concentrated protein formulations?

Optimization of a pharmaceutical freeze-dried product and its process

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

Container closure & integrity testing

Comparison of ice fog methods and monitoring of controlled nucleation success after freeze-drying.

Transient molten globules and metastable aggregates induced by brief exposure of a monoclonal IgG to low pH.

A critical evaluation of microcalorimetry as a predictive tool for long term stability of liquid protein formulations

Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences

Development and Application of a Mechanistic Cooling and Freezing Model of the Spin Freezing Step within the Framework of Continuous Freeze-Drying

Particle identification

High-Resolution Asymmetrical Flow Field-Flow Fractionation Data Evaluation via Richardson-Lucy-Based Fractogram Correction

Residual transglutaminase in collagen - effects, detection, quantification, and removal.

No Touching! Abrasion of Adsorbed Protein Is the Root Cause of Subvisible Particle Formation During Stirring.

What makes polysorbate functional? Impact of polysorbate 80 grade and quality on IgG stability during mechanical stress.

Comparison of Submicron Particle Counting Methods with a Heat Stressed Monoclonal Antibody

Formulation development

Baculovirus-driven protein expression in insect cells: A benchmarking study

Probing bis-ANS binding sites of different affinity on aggregated IgG

PLGA particulate delivery systems for subunit vaccines: Linking particle properties to immunogenicity.

Taking subvisible particle quantitation to the limit: Uncertainties and statistical challenges with ophthalmic products for intravitreal injection.

Binding of the HSF-1 DNA-binding domain to multimeric C. elegans consensus HSEs is guided by cooperative interactions

Project success stories

Photodegradation Pathways of Protein Disulfides: Human Growth Hormone.

Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress.

The impact of inadequate temperature storage conditions on aggregate and particle formation in drugs containing TNF-alpha inhibitors.

Exploring Chemical Space for New Substances to Stabilize a Therapeutic Monoclonal Antibody.

Global intercompany assessment of ICIEF platform comparability for the characterization of therapeutic proteins

Analytical Gaps and Challenges for Particles in the Submicrometer Size Domain

Protein aggregation: pathways, induction factors and analysis.

Cationic liposomes: a flexible vaccine delivery system for physicochemically diverse antigenic peptides.

Particulate impurities in cell-based medicinal products traced by flow imaging microscopy combined with deep learning for image analysis

Short-term study on in-use stability of opened bevacizumab biosimilar PF-06439535 vials

IgG1 adsorption to siliconized glass vials-influence of pH, ionic strength, and nonionic surfactants

Surfactant free preparation of biodegradable dendritic polyglycerol nanogels

Biophysical and biochemical characteristics of therapeutic proteins.

Simultaneous automated image analysis and Raman spectroscopy of powders at an individual particle level

Approaches to expand the conventional toolbox for discovery and selection of antibodies with drug-like physicochemical properties

Evaluation of Heat Flux Measurement as a New Process Analytical Technology Monitoring Tool in Freeze Drying

Vesicular phospholipid gels as drug delivery systems for small molecular weight drugs, peptides and proteins: State of the art review.

mRNA-lipid nanoparticle COVID-19 vaccines: Structure and stability

Aggregate analytics

BMI for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development.

New insights into process understanding of solid lipid extrusion (SLE) of extruded lipid implants for sustained protein delivery.

Fluorescence Spectroscopy to Characterize Protein Aggregates and Particles.

Protein-Protein Interaction

Biological safety levels

Flow imaging microscopy for protein particle analysis--a comparative evaluation of four different analytical instruments.

Contamination of anti-VEGF Drugs for Intravitreal Injection

Misconceptions over Förster resonance energy transfer between proteins and ANS/bis-ANS: Direct excitation dominates dye fluorescence.

Formulation of Cell-Based Medicinal Products: A Question of Life or Death?

Forced degradation studies

Implementation and evaluation of an optical fiber system as novel process monitoring tool during lyophilization.

Particle contamination of parenteralia and in-line filtration of proteinaceous drugs.

Quality of original and biosimilar epoetin products.

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Preformulation studies

Porosity and mechanically optimized PLGA based in situ hardening systems.

Recent advances and further challenges in lyophilization.

A new strategy to stabilize oxytocin in aqueous solutions: I. The effects of divalent metal ions and citrate buffer.

Continuous milli-scale reaction calorimeter for direct scale-up of flow chemistry

Basic formulation characterization

Quantitative Laser Diffraction for Quantification of Protein Aggregates

Particles in therapeutic protein formulations, Part 1: overview of analytical methods.

Mechanistic studies on the release of lysozyme from twin-screw extruded lipid implants.

Stress Factors in Monoclonal Antibody Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy.

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion

Stability studies

Critical Evaluation of MRPS for Quantification and Sizing of Nanometer- and Micrometer-Sized Particles

Taylor dispersion analysis compared to dynamic light scattering for the size analysis

Sizing the optimal dimensions of a vaccine delivery system: a particulate matter.

Intrinsic Differential Scanning Fluorimetry for Fast and Easy Identification of AAV Serotypes.

Systematic Studies on Stabilization of AAV Vector Formulations by Lyophilization

Comparability studies