INTRODUCTION Glycans are increasingly important in the development of new biopharmaceuticals with optimized efficacy, half-life, and antigenicity. Current expression platforms for recombinant glycoprotein therapeutics typically do not produce homogeneous glycans and frequently display non-human glycans which may cause unwanted side effects. To circumvent these issues, glyco-engineering has been...

The clinical impact of biotechnology has been constrained by the limitations of traditional hypodermic injection of biopharmaceuticals. Microneedle patches have been proposed as a minimally invasive alternative. In this study, the translation of a dissolving microneedle patch designed for simple, painless self-administration of biopharmacetucials that generates no sharp biohazardous waste is as...

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing pro...

Immunoglobulins G (IgG) could become widespread biopharmaceuticals if cost-efficient processes for their extraction and purification are available. In this work, aqueous biphasic systems (ABS) composed of polyethylene glycols and a buffered salt, and with ionic liquids (ILs) as adjuvants, have been studied as alternative extraction and purification platforms of IgG from a rabbit serum source. E...

The success of biopharmaceuticals started about 30 years ago with the first production of recombinant human insulin (Humulin®) in Escherichia coli, followed by the first production of human tissue plasminogen activator (tPA) in mammalian host cells some years later. Due to the lack of glycosylation in E. coli, which is required for the biological activity of most monoclonal antibodies, the use ...

In recent times competitive, commercial and fiscal pressures have introduced new and challenging issues for the pharmaceutical industry. This essay identifies some of these issues and proposes mechanisms for their resolution. This overview is not intended to serve as a comprehensive assessment, but rather as an introduction to and call for utilization of bioethics as a tool in the resolution of...

The therapeutic use of proteins has created an increasing demand for feasible and economical methods for both up- and downstream processes. However, whereas upstream processes have attracted substantial investment and commercial attention, downstream processing has been overlooked, causing a production bottleneck that is shifting the costs of production. This review focuses on the use of aqueou...

OBJECTIVES To evaluate the effect of consumer cost sharing on use of physician-administered and patient self-administered specialty drugs for rheumatoid arthritis. DESIGN Multivariate statistical analysis of probability and use of physician-administered specialty drugs, patient self-injected specialty drugs, non-biologic disease-modifying anti-rheumatic drugs, and symptom relief drugs. Analys...

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source pro...

Abstract Plants can be used to recombinantly produce high-quality biopharmaceuticals, such as therapeutic proteins and vaccines, also known plant molecular farming (PMF). Recent advances in engineering places PMF amongst the most innovative manufacturing technologies that reduce cost shorten production timeline. State-of-the-art uses a dual-approach strategy optimize generation of products, nam...