The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
It can be said that 2014 was the year of genomics. The industry saw several new startups in the area, and Google's venture into the genomics market made a big splash. However, in 2015 the industry is expected to look beyond genes and focus on a dual approach to drug development leveraging data from both the genes and the tissue, particularly in oncology.
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.
It has become increasingly evident that closed impeller bioreactors provide an optimal manufacturing solution for vaccines, biologics, and cell therapeutics. The precision controls and small foot print of the reactor coupled with the large surface area for cell culture and growth provided by microcarriers has made these systems a staple in the biotechnology industry where adherent cells are required in large numbers.
mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate. Additionally, the contaminant HCP content is process-dependent.
In the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.
A significant proportion of academic and drug discovery research is devoted towards the elucidation of second messenger signaling cascades resulting from interactions between G-protein coupled receptors (GPCR) and their ligands. By Paul Held Ph. D. and Peter Banks, Ph. D., BioTek Instruments, Inc. and Paul Tewson, Anne Marie Quinn and Thom Hughes, Montana Molecular
We describe the use of a non-radioactive, bioluminescent Antibody-Dependent Cell- Mediated Cytotoxicity (ADCC) assay. The protocol is a simple sequential addition of reagents and cells that can be readily automated with a simple, inexpensive pipetting station.
America's biopharmaceutical companies are using biological processes to develop 907 medicines and vaccines targeting more than 100 diseases, according to a new report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).
Baxter International Inc. has begun dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company’s efforts to extend its oncology portfolio with advanced biological research and development.
Sirnaomics, Inc. (www.sirnaomics.com) announced today that the company has been awarded another NIH SBIR (Small Business Innovation Research) grant for developing its small interfering RNA (siRNA) therapeutic product STP705 to improve skin wound healing with minimized scar formation.