Technical Papers

182 Results

Pharmaceutical Development for ADCs

Pharmaceutical Development for ADCs

Content provided by Baxter BioPharma Solutions | 08-Sep-2014 | White Paper

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex.While the development of an aqueous solution formulation...

Eppendorf

Production of Human Stem Cells in Single-Use Vessels

Content provided by Eppendorf Bioprocess Solutions | 11-Aug-2014 | Application Note

Although successful expansion of mesenchymal stem cells (MSCs) in vitro has been well established, the large clinical-scale production of MSCs remains...

Seamless Scale-Up of Lyophilized Vial Products

Seamless Scale-Up of Lyophilized Vial Products

Content provided by Patheon Inc | 04-Aug-2014 | Case Study

Manufacturers often face a challenge of scaling-up products while maintaining consistency. Learn how to scale-up such lyophilized products as formulations...

Smarter supply chain strategies for you

Smarter supply chain strategies for you

Content provided by World Courier | 28-Jul-2014 | Data Sheet

The growing prominence of initiatives like just-in-time supply in the clinical trial market points to two key trends in pharmaceutical development: first,...

Eppendorf

Taking the Strain: Scalable Vaccine Production

Content provided by Eppendorf Bioprocess Solutions | 21-Jul-2014 | Case Study

Today, the rapidly expanding demand for vaccine products for viral diseases such as rabies has necessitated the development of more sophisticated production...

SGS Group Management

Ligand Binding Analysis Using Surface Plasmon Resonance

Content provided by SGS Life Science Services | 23-Jun-2014 | White Paper

When ligand binding is part of the functional activity of a biopharmaceutical, FDA and EMA guidelines require this property be quantified. The Biacore...

DoE Bioprocess Development

DoE Bioprocess Development

Content provided by Eppendorf Bioprocess Solutions | 16-Jun-2014 | Data Sheet

Design of Experiments (DoE) is a structured approach to the development and optimization of pharmaceutical processes. Compared with a one-factor-at-a-time...

Boehringer Ingelheim

Setting the Standard for Plasmid DNA Production

Content provided by Boehringer Ingelheim Biopharmaceuticals GmbH | 06-Jun-2014 | Data Sheet

Boehringer Ingelheim stands out due to global contract manufacturing excellence in plasmid DNA production. It is one of the world’s leading companies for...

Steris

Do you have spores?

Content provided by Steris: A global leader in infection prevention and contamination control | 27-May-2014 | White Paper

Trending analysis of cleanroom environmental monitoring data sometimes shows the presence of spores. These undesirable microbes must be eradicated quickly...

LB3 Limited

Ambr™ for cell line and process development

Content provided by Information not available | 14-Apr-2014 | Case Study

Requirements for rapid development have pushed process runs to a higher throughput in smaller scale. Implementation of a microbioreactor system allows...

Applikon

RAMbio, the high intensity mixer

Content provided by Applikon Biotechnology | 31-Mar-2014 | White Paper

The RAMbio® bench top biological mixer utilizes ResonantAcoustic® technology that applies low-frequency, high-intensity acoustic energy to agitate microbial...

Developing a bioformulation stability profile

Developing a bioformulation stability profile

Content provided by Information not available | 27-Mar-2014 | White Paper

Rapidly identifying stable biotherapeutic formulations is critical to reducing development costs and determining a biotherapeutic's future success....

Eppendorf

Bioprocess Optimization by MS Integration

Content provided by Eppendorf Bioprocess Solutions | 10-Mar-2014 | Application Note

With its comprehensive data management the Eppendorf DASware® Software Suite allows seamless integration of a Thermo Scientific® Prima® dB Mass Spectrometer...

Global Disposable Concept at Boehringer Ingelheim

Global Disposable Concept at Boehringer Ingelheim

Content provided by Boehringer Ingelheim Biopharmaceuticals GmbH | 18-Feb-2014 | White Paper

Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals. We are a global service...

SGS Group Management

CONFIDENCE IN BIOLOGICS FORMULATION DESIGN

Content provided by SGS Life Science Services | 10-Feb-2014 | White Paper

To ensure a long product shelf-life for biopharmaceutical drug products, a stable storage environment is critical. Determination of the optimal environment...

Temperature-Controlled IMP Distribution Challenges

Temperature-Controlled IMP Distribution Challenges

Content provided by Almac Group | 09-Dec-2013 | White Paper

UNDERSTANDING THE CHALLENGES OF TEMPERATURE CONTROLLED INVESTIGATIONAL MEDICINAL PRODUCT DISTRIBUTION IN EMERGING MARKETSTemperature deviation within the...

Fermentation in BioBLU® f Single-use Bioreactors

Fermentation in BioBLU® f Single-use Bioreactors

Content provided by Eppendorf Bioprocess Solutions | 18-Nov-2013 | Application Note

Single-use bioreactor solutions have been successfully established in animal and human cell culture in the last years. Now this technology is going to...

Rocket 4D Automatic Evaporation of Large Volumes

Rocket 4D Automatic Evaporation of Large Volumes

Content provided by Genevac | 11-Nov-2013 | Data Sheet

Why stay trapped in the glassy world of production scale rotary evaporators when freedom is at hand. You can exchange the need for frequent monitoring...

Eppendorf DASbox® Mini Bioreactor System

Eppendorf DASbox® Mini Bioreactor System

Content provided by Eppendorf Bioprocess Solutions | 11-Nov-2013 | Data Sheet

The smart design of the Eppendorf DASbox makes the 4-fold units ideal for parallel processing of 4, 8, 12 or more bioreactors. Together with the Eppendorf...

Expansion of Stem Cells in Single-use Bioreactors

Expansion of Stem Cells in Single-use Bioreactors

Content provided by Eppendorf Bioprocess Solutions | 21-Oct-2013 | Application Note

The routine application of human pluripotent stem cells and their derivatives in regenerative medicine and innovative drug discovery will require the constant...

Mini Scale Parallel Cultivation of Human CAP® Cells

Mini Scale Parallel Cultivation of Human CAP® Cells

Content provided by Eppendorf Bioprocess Solutions | 30-Sep-2013 | Application Note

Increasing process complexity coupled with rising cost pressures and rapidly evolving regulatory requirements makes today’s process development efforts...

SGS

TRANSMISSION ELECTRON MICROSCOPY IN BIOSAFETY TESTING

Content provided by SGS Life Science Services | 23-Sep-2013 | White Paper

TEM allows for visualization of virus particles, particle size, morphology, and intra- and extra-cellular location, both in biological fluids and in vitro....

ATMI

Simpler and Faster Viral Vector Production Scale-Up

Content provided by ATMI Life Science | 23-Sep-2013 | White Paper

Discover how to efficiently produce wild-type or recombinant viruses to be used as vaccines and human gene therapy vectors. Learn more about results achieved...

Eppendorf

Parallel Fermentation using Single-Use Bioreactors

Content provided by Eppendorf Bioprocess Solutions | 16-Sep-2013 | Case Study

The following case study shows how reproducible results were achieved with the new Eppendorf BioBLU® 0.3f vessel used in parallel process runs. Fermentation...

sgs

Nucleic Acid Amplification Technique for Biosafety

Content provided by SGS Life Science Services | 09-Sep-2013 | White Paper

Use of cutting-edge NATs reduces the amount of time needed for development and safety testing of novel biotech products. This white paper describes specific...

Biosafety Testing: In Vitro Virus Detection

Biosafety Testing: In Vitro Virus Detection

Content provided by SGS Life Science Services | 06-Sep-2013 | White Paper

Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing...

Biosimilar Development: The Race to Market

Biosimilar Development: The Race to Market

Content provided by SGS Life Science Services | 06-Sep-2013 | White Paper

This article provides an update on the current regulatory situation for biosimilars, and addresses the issues with demonstrating physicochemical similarity,...

ATMI

How to Industrialize Stem Cell Culture Processes?

Content provided by ATMI Life Science | 25-Jun-2013 | White Paper

Learn about the scale-up of allogeneic stem cell processe, from multi-tray stacks to the Intergity® XpansionTM multiplate bioreactor. Results demonstrated...

ATMI

Virus Production: From Bench to Industrial Scale

Content provided by ATMI Life Science | 25-Jun-2013 | Case Study

Discover the linear scale-up of various viral production process using the Integrity® iCELLis®, a scalable range of disposable fixed-bed bioreactors operating...