Articles in this Issue
Ms. Anja Trapp, Ms. Sabine Faust
Mammalian cells are most frequently used for recombinant monoclonal antibody (mAb) production today. However, there is a certain risk of virus contamination when using mammalian cell culture systems. Furthermore, non-infectious Retrovirus-like particles (RVLP) are detectable in CHO cell culture supernatans by qPCR methods and electron microscopy.
Peter Tattersall, Ph.D., Brent L. Kleintop, Dr. Xuejun Xu
Analytical method transfers to external testing sites are required by health authorities to ensure both quality of clinical materials provided to patients, and effective testing during registrational stability studies.
Over the recent decades, the pharmaceutical industry has shifted focus to new modalities for disease treatment. The so-called “Biologics”, involves administration of proteins cells and nucleic acids derived drugs, with therapeutic proteins (TP) currently representing the major portion in the biologics field. To reduce the risk of potential failure during technical development due to unexpected liabilities, protein candidates require a careful assessment of their developability profile as early as possible in the process.
Girish Malhotra, PE
Recent layoffs and closures in the pharmaceutical industry have been on the horizon for some time. However, it seems the signs have been ignored.
Dr. Sandra Prior, Dr. Simon E. Hufton
Monoclonal antibodies (mAbs) are a highly successful class of drugs which have revolutionized the treatment of many important diseases in oncology and inflammation. Unlike chemically synthesised small molecule medicines, mAbs are complex multi-chain glycoproteins produced in living cells using sophisticated manufacturing processes.
Dr. Iva Turyan, Dr. Tyler Carlage
In this article, analytical strategies for characterization of N-linked glycosylation and monosaccharides have been compared. The application of hydrophilic interaction chromatography with fluorescence detection (HILIC-FLR) and capillary electrophoresis with laser-induced fluorescence (CE-LIF) for N-glycan analysis, including a discussion of the advantages and disadvantages of these commonly applied analytical techniques for N-glycan analysis are discussed.
Jennifer Fox
It has been approximately eight years since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law by President Obama as part of healthcare reform. Among other things, the BPCIA created an abbreviated pathway for regulatory approval of therapeutic biologics.
Gattefossé is a key provider of specialty excipients and drug delivery solutions based on lipid chemistry, transforming naturally occurring raw materials like vegetable oils into sophisticated, well-defined, fully characterized, safe, and functional ingredients.
Historically, biologics have been manufactured in large stainless steel bioreactors. The powdered media and buffers was charged by open manways, allowing powder to escape, and increase the chance of contamination. This was fine when one product is being made inefficiently at large scale.
The growth in specialty and more patient-centric medicines, and the need for specialized enabling technologies with which to bring these to market, are driving an increase in outsourcing and partnering across the pharmaceutical industry.
Diffusion and erosion mechanisms are the essentials of controlled release technologies.
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in March-April 2018.
Saly Romero-Torres, Ph.D., Kimberly Wolfram, John Armando, Dr. Syed Kaschif Ahmed, Dr. Jun Ren, Chao Shi, Dan Hill, Dr. Rob Guenard
As the pharmaceutical industry moves into the cyber-physical era, sometimes referred to as Industry 4.0, it will be imperative to harmonize terminology and expectations when developing advanced manufacturing technologies to accelerate their successful adoption and maturity.