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Pharma and biopharma manufacturing
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One-step Feed Optimization for Upstream Cell Culture Processes
Optimizing feed for upstream cell culture improves monoclonal antibody production, but requires balancing outcomes for both viable cell density and productivity.
Upstream Bioprocessing Feed Strategies and Scalability: A Case Study with Cellvento® ModiFeed Prime COMP
This case study walks through optimizing feed and media for upstream bioprocessing and how it translates to large-scale bioreactors.
Drospirenone Assay - USP Monograph
Determination of the progestin medication, Drospirenone, using Purospher® STAR RP-18e Hibar® HPLC column and meeting the system suitability criteria as described in the USP monograph.
Bioburden Control in Bioprocessing
Bioburden control in bioprocessing requires assessing the risks, mitigating the risks, and monitoring bioburden levels.
Tangential Flow Filtration in the Antibody Drug Conjugate (ADC) Manufacturing Process
Find best practices for using Pellicon® Capsules in ADC processing as well as data from two studies using Pellicon® Capsules and Pellicon® cassettes in the ADC manufacturing process.
API Solubility and Dissolution Enhancement Via Formulation
Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.
An Optimized Protocol for Peptide Mapping of Therapeutic Monoclonal Antibodies with Minimum Deamidation and Oxidation Artifacts
An optimized peptide mapping protocol using NISTmAb as a model monoclonal antibody, shorter incubation times, and improved digestion buffer to demonstrate minimal artificial asparagine deamidation and methionine oxidation.
Scalability Challenges of Viral Vector Manufacturing
Scaling up viral vector production using adherent cell culture systems is challenging. Learn how suspension cell culture systems benefit large-scale bioprocessing.
Bioreactor Process Development and Scale-Up for Transient Transfection-Based Lentivirus Manufacturing in Suspension Cell Culture
A step-by-step overview of suspension-based, transient transfection bioreactor process development and scaleup of lentivirus production.
Cell Retention Technology and Specialized Cell Culture Media for Intensified Upstream Processing
How the Cellicon® filter and controller enables seamless adoption of a perfused N-1 seed train step into the cell expansion process.
Lentivirus Platform: Optimizing Performance for De-Risked Production
Learn how the VirusExpress® lentivirus platform utilizes DoE experiments and supplementary studies to optimize workflows, enhance yield, and ensure quality in cell and gene therapies.
Plasmid DNA (pDNA) Manufacturing Process: Downstream Purification
Get a step-by-step overview of the plasmid DNA manufacturing process and the challenges in pDNA downstream purification. Read our free pDNA downstream purification eBook for mRNA, plasmid-based DNA Vaccines, and Viral Vector applications.
Impact of DMSO And Freezing Technique in Developing a High Cell Density Cryopreservation Process for Upstream Bioprocessing
Understand how considerations such as DMSO concentrations and freezing techniques are key in the successful implementation of high cell density cryopreservation (HCDC).
Seed Train Intensification Using High Cell Density Cryopreservation
High cell density cryopreservation (HCDC) is a closed processing alternative to the traditional seed train expansion process. Learn more about the benefits of HCDC.
What is Multi Column Chromatography?
Multi column chromatography has the benefit of using less resin, increasing productivity, and enabling continuous processing. Learn more in this technical article.
One-Batch Calibration: A Process-, Instrument-, Scale- & Site-agnostic Method For Streamlining Raman Implementation
Challenges associated with Raman spectroscopy implementation in bioprocesses can be overcome by the innovative one-batch calibration approach. This streamlined process requires less time and resources compared to traditional approaches, unlocking Raman benefits for biopharmaceutical applications.
Determination of N-Nitrosamines in Valsartan
Nitrosamines have been discovered as a serious contaminant group in active pharmaceutical ingredients (API) belonging to the sartan family. This article describes a GC-MS method for the determination of nitrosamines in Valsartan tablets according to US FDA guide lines that
Chemically Defined Media Supplements Improve Quality and Lower Risk in Upstream Bioprocessing
Chemically defined media supplements offer many benefits including decreased lot-to-lot variation, decreased risks, and improved glycosylation profiles.
Optimizing Upstream Media and Feeds in Bioprocessing
Why optimize your upstream bioprocess media and feed? This article discusses the why and how of optimizing your media and feed to maximize cell viability and productivity.
Protein Binding Determination Using Supel™ BioSPME C18 Pin Device as Part of the Manual Methodology With and Without Shaking
The application note describes a comparative analysis of plasma protein binding results for free/bound drugs using two different sample extraction steps, with and without agitation.
Dry Granulation in Solid Oral Formulation: Advantages of Spray-Dried Mannitol in Roll Compaction
In recent years, mannitol has gained popularity as an excipient in solid dosage formulation due to its beneficial physicochemical properties.
Solid Formulation Development Using Melt-based 3D Printing Technologies
3D printing can overcome challenges during formulation development, with a focus on enhancing API bioavailability in solid dispersions. Find out how in this technical article.
Bioprocessing And Scale-Up Of Suspension HEK293 Cells For AAV Manufacturing
To address scalability challenges of AAV manufacturing, we developed an HEK293 suspension cell line that can be used across many serotypes. Get the data in this article.
Improving Fed-batch Yields in Upstream Bioprocessing
Our step-by-step guide to optimizing media and feed combinations for upstream bioprocessing.
Tangential Flow Filtration in Downstream Bioprocessing
There are many options for tangential flow filtration (TFF) in downstream bioprocessing from multi-use to single-use TFF or batch TFF and single-pass TFF.
Single-Pass Tangential Flow Filtration Implementation and Scaling
Get practical guidance on using single-pass tangential flow filtration in your downstream process and scaling between capsules and cassettes.
Viscosity Reduction in High Concentration TFF
This overview describes how use of viscosity-reducing excipients can address viscosity challenges in high concentration tangential flow filtration (TFF) and improve process economics.
Improving Antibody-drug Conjugate (ADC) Solubility with Hydrophobic Novel Payloads Using the Chito-oligosaccharide ChetoSensar™
See the data on how the chito-oligosaccharide ChetoSensar™ overcomes ADC solubility challenges.
Simplifying Antibody-Drug Conjugate Payload Synthesis Using Payload Intermediates
Meta description: ADC payload intermediates such as, DOLCore ™, MAYCore ™, and PBDCore ™, simplify payload synthesis for the most commonly used payloads: maytansine, dolastatin, and PBD dimers.
Chromatographic Purification of Plasmid DNA (pDNA) for mRNA, Plasmid-based DNA Vaccines, and Viral Vector Applications
See case study examples of how to optimize chromatographic purification of plasmid DNA for Biopharmaceutical Applications.
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