Search results for " reproducibility"
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical …
Article
Achieving Efficient Adenovirus Upstream Production
Adenovirus is one of the most frequently used viral vectors in the development of therapeutic vaccines and vaccines against infectious diseases. Adenovirus has also been explored as a viral vector f…
Article
NIST Spectroscopic Measurement Standards
RM 8671 (reference material, the NISTmAb) can then be used to ensure the accuracy and reproducibility of protein concentration measurements by providing an industrially relevant reference material, a …
Article
Flow Accuracy and Gradient Performance of ÄKTA pilot 600 Chromatography System
Accurate flow is important for your chromatography step to provide reproducible results at different scales. A comparable flow accuracy between scales can facilitate scaling of your methods.
In…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
…d convenient for a wide range of animal cell cultures, a key disadvantage is the possibility of poor reproducibility originating from the lack of knowledge of the exact composition (4). Synthetic or …
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…