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.
As the Pharma 4.0 initiative sets a new industry paradigm, more biomanufacturing companies are asking how they can design and build facilities that apply risk-based thinking to manufacturing innovation.
To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging transposon-based gene delivery to compress timelines, increase clone stability, and offer...
The future of the biopharmaceutical industry hinges on its adoption of 21st-century digital tools and automation.
A must-read for all bioprocess scientists: This bundle of four ebooks created by Eppendorf guides you through the world of upstream bioprocessing.
The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative methods such as PCR and NGS have emerged these in vivo tests have stubbornly remained a central...
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.
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.
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.
Aflibercept (Zaltrap®) is a recombinant fusion protein with complex post-translational modifications. Therefore deep understanding of biosimilar development is required to develop a biosimilar like Aflibercept. UGA Biopharma has successfully completed...
Download the eBook written by Catalent experts to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize performance potential, novel analytical techniques for monoclonal...
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...
The Mastercycler X50 is Eppendorf's new PCR cycler with lots of new benefits. Not only can you heat with 10°C/s, you can also optimize two different temperatures in one run, e.g. the denaturation...
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...
The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. The two pharmacopeia techniques rely on the agar/broth culture test to detect...
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...
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...
When developing efficient, high quality biomanufacturing processes, it is imperative that the expression system (‘host cell line’ and ‘vector’) and the process to isolate and identify the...
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...