Technical Papers

158 Results

Single-use systems designed for your workflow

Single-use systems designed for your workflow

Thermo Fisher Scientific | 01-Apr-2015 | Technical / White Paper

Fluid transfer is an integral part of any biopharmaceutical manufacturing process, and one that can prove challenging. Choosing a customized, single-use...

Demonstrate Biosimilarity of Insulin Biosimilars

Demonstrate Biosimilarity of Insulin Biosimilars

SGS Life Science Services | 30-Mar-2015 | Technical / White Paper

Download this white paper to learn about two SGS developed assays used to show comparability in reactivity between the reference product and the biosimilar...

Applikon Biotechnology B.V

Generating scalable results in micro-bioreactors

Applikon Biotechnology | 23-Mar-2015 | Technical / White Paper

Micro-bioreactors are gaining market share in R&D laboratories. Common applications are strain selection, medium optimization and optimization of cultivation...

Global Ethics - what you need to ensure integrity

Global Ethics - what you need to ensure integrity

World Courier | 16-Mar-2015 | Technical / White Paper

In a recent World Courier survey, 35% of respondents said that they were aware of bribery in their industries. This may have been acceptable in the past...

Use H₂O₂ sterilization techniques with confidence

Use H₂O₂ sterilization techniques with confidence

Thermo Fisher Scientific | 01-Mar-2015 | Application Note

Sterilizing work spaces and containers is an important part of working with sensitive cells. As a highly efficient antimicrobial agent, hydrogen peroxide...

Regulatory Support for Critical Containment

Regulatory Support for Critical Containment

Thermo Fisher Scientific | 09-Feb-2015 | Technical / White Paper

Choosing the right container is an important factor during pharmaceutical production. Chemicals present within packaging materials can leach into the product,...

Quantitative Analysis of Bioprocess Engineering Parameters

Quantitative Analysis of Bioprocess Engineering Parameters

Eppendorf for Bioprocess – Solutions that grow with you | 02-Feb-2015 | Data Sheet

This poster characterizes the capabilities of the new Eppendorf BioFlo® 320 bioprocess control station in terms of key process parameters including oxygen...

Meaningful Metrics – A CMO Perspective

Meaningful Metrics – A CMO Perspective

Patheon Inc | 26-Jan-2015 | Technical / White Paper

Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage...

Broad spectrum pyrogen detection according to pharmacopoeia

Broad spectrum pyrogen detection

EMD Millipore | 08-Dec-2014 | Application Note

The Monocyte-Activation Test (MAT), which was introduced into the European Pharmacopoeia in 2010, detects pyrogens in pharmaceuticals. It covers a much...

The scalable solution to consistent cell culture

The scalable solution to consistent cell culture

Thermo Fisher Scientific | 07-Nov-2014 | Case Study

From research through to full scale bioproduction, you need a system that delivers reliable results, makes effective use of space and is easy to scale...

Directed evolution creates superior CHO cell lines

Directed evolution creates superior CHO cell lines

Fujifilm Diosynth Biotechnologies | 03-Nov-2014 | Data Sheet

Directed evolution is an iterative approach where selective pressure is applied to a system to identify variants with desirable characteristics, in this...

5-step guide to Temp-control using passive systems

5-step guide to Temp-control using passive systems

World Courier | 20-Oct-2014 | Technical / White Paper

Maintaining the strict temperature parameters required to ensure product stability is relatively straightforward in the plant or laboratory setting, where...

Viral-Challenge Studies: Regulatory Requirements

Viral-Challenge Studies: Regulatory Requirements

SGS Life Science Services | 13-Oct-2014 | Technical / White Paper

The use of viral-challenge studies as POC studies is gaining wider acceptance. This approach accelerates the selection of a safe and effective dose and...

Single-Use Practices for Cleanroom Fluid Transfer

Single-Use Practices for Cleanroom Fluid Transfer

AdvantaPure® | 29-Sep-2014 | Technical / White Paper

Pharmaceutical and biopharma manufacturers must transfer fluids from room to room quickly with maximum productivity and minimal effort and expense. By...

Turning “Oh No” into “No Problem”

Turning “Oh No” into “No Problem”

World Courier | 15-Sep-2014 | Technical / White Paper

With all that’s going on in the world right now it’s vital for us all to have plans in place to deal with the unexpected. We need to be prepared individually,...

Bacteria Welcome – BioBLU® f Single-Use Vessels

Bacteria Welcome – BioBLU® f Single-Use Vessels

Eppendorf for Bioprocess – Solutions that grow with you | 15-Sep-2014 | Data Sheet

The BioBLU 0.3f and BioBLU 1f Single-Use Vessels allow microbial process development at the highest level. These rigid wall stirred-tank single-use vessels...

Pharmaceutical Development for ADCs

Pharmaceutical Development for ADCs

Baxter BioPharma Solutions | 08-Sep-2014 | Technical / White Paper

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

Analysis & Control of Particles in Biologics

Analysis & Control of Particles in Biologics

SGS Life Science Services | 08-Sep-2014 | Technical / White Paper

A key challenge for companies developing biologics is the control of particles in the product formulation. Regulatory authorities require information on...

Eppendorf

Production of Human Stem Cells in Single-Use Vessels

Eppendorf for Bioprocess – Solutions that grow with you | 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

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

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

Eppendorf for Bioprocess – Solutions that grow with you | 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...

DoE Bioprocess Development

DoE Bioprocess Development

Eppendorf for Bioprocess – Solutions that grow with you | 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

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?

Steris: A global leader in infection prevention and contamination control | 27-May-2014 | Technical / 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

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

Applikon Biotechnology | 31-Mar-2014 | Technical / 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

Information not available | 27-Mar-2014 | Technical / 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

Eppendorf for Bioprocess – Solutions that grow with you | 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

Boehringer Ingelheim Biopharmaceuticals GmbH | 18-Feb-2014 | Technical / 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

SGS Life Science Services | 10-Feb-2014 | Technical / 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

Almac Group | 09-Dec-2013 | Technical / 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

Eppendorf for Bioprocess – Solutions that grow with you | 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...

Eppendorf DASbox® Mini Bioreactor System

Eppendorf DASbox® Mini Bioreactor System

Eppendorf for Bioprocess – Solutions that grow with you | 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

Eppendorf for Bioprocess – Solutions that grow with you | 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

Eppendorf for Bioprocess – Solutions that grow with you | 30-Sep-2013 | Application Note

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

ATMI

Simpler and Faster Viral Vector Production Scale-Up

ATMI Life Science | 23-Sep-2013 | Technical / 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...