News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
The customer has a central role in Sacco System and we are now ready to offer our Made4You service. We can support you in the development and study of a new microbiome solution in the food and pharmaceutical space, but our help will continue also with...
Join us as our in-house experts, along with Cecile Bellamy from Pfizer, discuss current and future trends in biopharmaceutical raw material selection.
This mRNA eBook was created by Thermo Fisher Scientific, in collaboration with Genetic Engineering & Biotechnology News (GEN), to provide you with prospects of the mRNA technology, tips on scaling up mRNA production, and analytical solutions for mRNA...
Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs given.
A must-read for all bioprocess scientists: This bundle of four ebooks created by Eppendorf guides you through the world of upstream bioprocessing.
Effective drug discovery and development relies on the availability of predictive preclinical model systems. Technologies based on human induced pluripotent stem cells (hiPSC) hold great promise to overcome this challenge. In this application note...
Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility, and reduce COGs.
This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives in combination with either a conventional fed-batch or high-seed fed-batch bioreactor.
Experimentation at small scale is crucial for the cost-efficient development of bioprocesses, which then can be transferred to larger volumes. We have proven the feasibility of ATF-based perfusion using the DASGIP Parallel Bioreactor System.
We successfully performed microaerobic fermenta¬tion of a probiotic strain, Lactobacillus acidophilus, at a very low oxygen level, representing the natural physiological condition of human gut microbiome, using BioFlo® 120 and 320 control stations.
Rising interest in gene therapy-based applications leads to increasing demands in scalable production systems for viral vectors. Find out how Cevec Pharmaceuticals adapted a small scale shake flasks rAAV production process to stirred-tank bioreactors.
Therapeutic proteins are inherently unstable and sensitive to temperature change, shearing, shaking, solvents, ionic strength, purity, protein concentration, pressure and freeze/thaw-drying cycles. Read our latest research in this case study to learn...
Perfusion cell culture processes promise advantages for industrial bioprocessing, like saving space, increasing volumetric productivity, achieving more consistent product quality, and improving production of less stable proteins. Download our poster.
Our newest strong anion exchange resin provides both high binding capacity and high recovery, even at high flow rates. A rigid bead complete with optimized pores and surface extenders, this robust resin was designed for your large...
3D cell aggregates are of great interest for applications like disease modeling and manufacturing of stem cell-based products. Read more about the cultivation of the human tumor cell line H157 as 3D cell aggregates in a stirred-tank bioreactor.
Accelerate Your Process Development. Your technology selection guide for the clarification of mAb processes.
At Pall we have supported the water intrusion test for more than 20 years and we developed the Palltronic® AquaWIT IV system to deliver fast and simple automated in-situ testing of gas and vent filters wherever they are located.
In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals. The key objective of the survey was to gauge views about the current state of the global...
For many years cylindrical stainless steel tanks have been used in biopharmaceutical production.The primary reason for the cylindrical shape was that it provided the mechanical stability required...
Single-use bioreactors have only been cylindrical in design, until now. The Allegro™ STR single-use, stirred tank bioreactor provides advantages over the traditional cylindrical shape. Download...
The Auto Culture modes, standard on the Eppendorf BioFlo® 120 bioprocess control station, offer push-button automatic process control for some of the most common microbial and mammalian cultures....
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current state of the biopharmaceutical...
Screening of large number of cell lines, specific media or target drug could be tedious and expensive work. This is also the case for the characterization of multiple bio-engineered strains...
SGS scientists have validated a multiplex, bead-based immunoassay which determines nine cytokines simultaneously per sample, resulting in savings in costs, sample volume, and time. Download this...
The Applikon BioSep system is a unique, cell retention device for high-density perfusion processes. BioSep is the ultimate tool for cell culture perfusion from 100 ml scale bioreactor up to...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...