Content provided by Eppendorf Bioprocess Solutions | 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...
Despite the controversy surrounding the thicket of regulatory requirements for approval of biosimilars in various markets, regulatory agencies and governments...
Content provided by Patheon Inc | 26-Jan-2015
| White Paper
Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage...
Content provided by Pall Biotech | 21-Jan-2015
| Application Note
Fab antibody fragments have been increasingly used for therapeutic applications. Expressed at high yield, they are very specific and lack the Fc portion...
Content provided by 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 Monocyte-Activation Test (MAT), which was introduced into the European Pharmacopoeia in 2010, detects pyrogens in pharmaceuticals. It covers a much...
In recent years single-use bioreactors gained more and more importance in mammalian cell culture. With the new line of BioBLU f rigid wall, stirred-tank...
Content provided by 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...
Content provided by 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...
Content provided by World Courier | 20-Oct-2014
| White Paper
Maintaining the strict temperature parameters required to ensure product stability is relatively straightforward in the plant or laboratory setting, where...
Content provided by SGS Life Science Services | 13-Oct-2014
| 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...
Content provided by Boehringer Ingelheim Biopharmaceuticals GmbH | 30-Sep-2014
| White Paper
This whitepaper will focus on the interaction and collaboration with externals customers when transferring processes from a customer to one of Boehringer...
Content provided by AdvantaPure® | 29-Sep-2014
| White Paper
Pharmaceutical and biopharma manufacturers must transfer fluids from room to room quickly with maximum productivity and minimal effort and expense. By...
Content provided by World Courier | 15-Sep-2014
| 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,...
Content provided by Eppendorf Bioprocess Solutions | 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...
Content provided by SGS Life Science Services | 08-Sep-2014
| White Paper
A key challenge for companies developing biologics is the control of particles in the product formulation. Regulatory authorities require information on...
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...
Although successful expansion of mesenchymal stem cells (MSCs) in vitro has been well established, the large clinical-scale production of MSCs remains...
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...
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,...
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...
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...
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...
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...
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...
Fujifilm Diosynth Biotechnologies | Recorded the 28-May-2014 | Webinar
The development of large scale E. coli expression systems can be rate limiting in process development. Fujifilm's pAVEway™ system combines innovative...
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...
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...
With its comprehensive data management the Eppendorf DASware® Software Suite allows seamless integration of a Thermo Scientific® Prima® dB Mass Spectrometer...
Content provided by World Courier | 24-Feb-2014
| White Paper
The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical...
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...
Content provided by World Courier | 17-Feb-2014
| Data Sheet
World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared. A year on from the...
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...
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...
Single-use bioreactor solutions have been successfully established in animal and human cell culture in the last years. Now this technology is going to...
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...
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...
The routine application of human pluripotent stem cells and their derivatives in regenerative medicine and innovative drug discovery will require the constant...
Increasing process complexity coupled with rising cost pressures and rapidly evolving regulatory requirements makes today’s process development efforts...
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....
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...
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...
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...
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...
Content provided by Novasep | 06-Sep-2013
| Case Study
Molecules reaching the market in the recent years present an ever-growing complexity. In the meantime, purity criteria are more stringent than ever to...
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,...
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...
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...
