Biotherapeutic products

Nearly every biotherapeutic product involving chronic or longterm use would benefit from non-invasive delivery, which could provide pharmaceutical companies with a competitive advantage, expand the market for... 

In practice, most animal cell-derived biotherapeutic products are evaluated by a series of meetings with experts from the regulatory bodies to discuss results and thus build up an overall picture of the cell line and its product. In particular, virus testing procedures are important to exclude contamination of therapeutic products, and therefore have to be exhaustive. Regulatory authorities may request an extended range of tests, including retrovirus testing. 

Arden, N., Nivitchanyong, T, and Beten-baugh, M.J. (2004) Cell engineering blocks cell stress and improves biotherapeutic production. Bioprocess. J. 2 23—28. 

The quality and utility of each RM will be greatly enhanced by the availability of a set of amide exchange rate coefficients derived from measurements by an orthogonal method, such as HX-NMR. The physical properties of proteins and their behaviors during proteolysis vary considerably. The optimum set of reference proteins should reflect these varied behaviors. This will enable researchers to pair the measurement difficulties of their commercial biotherapeutic product with a primary RM. The chosen primary RM can then be used to measure HX-MS laboratory performance over time and location. 

DiazSL,Padler-Karavani V,GhaderiD, Hurtado-ZiolaN, Yu H,ChenX,Brinkman-Vander Linden EC, Varki A, Varki NM (2009) Sensitive and specific detection of the non-human sialic acid V-glycolyneuraminic acid in human tissues and biotherapeutic products. PLoS One 4 e4241... 

New technologies are also addressing the pulmonary delivery of the new biotherapeutics , i.e. the products of biotechnology and molecular biology such as peptides, proteins and gene therapies which have been described in detail in Chapter 1 (Section 1.6). Biopharmaceuticals under investigation for potential pulmonary delivery include those for local, and systemic, effects (Table 10.4). 

There is a range of regulatory guidelines relevant to the utilization of cell lines or their products in the manufacture of both biotherapeutic and diagnostics. 

Alkylating agents Antimetabolites Natural products Hormonal agents Biotherapeutic agents Miscellaneous agents... 

Antibody therapeutics can potentially treat diseases that can be as diverse as autoimmune disorders to cancer and infectious diseases. Antibodies are currently rated as an important and growing class of biotherapeutics. Other than vaccines, monoclonal antibodies currently in development outnumber all other classes of therapeutics. Recombination technology plays a key role in the development and commercialization of therapeutic antibodies. In fact, eight of nine antibody products on the... 

THROMBATE III (Bayer) is a plasma-derived product that is used to treat AT-III deficiency, the first inherited trait discovered which was identified in 1965. The condition is associated with thrombophilia caused by low levels of AT-III or the presence of altered AT-III activity. Both conditions can result in excessive blood clotting. Acquired AT-III deficiency is another condition that occurs in situations with high risk of thrombosis such as trauma, burns, and sepsis. GTG Biotherapeutics conducted chnical trials with ATryn in high-risk situations such as surgery or child de-Hvery to prevent deep-vein thrombosis in hereditary AT-III-deficient patients and heparin-resistant patients with acquired AT-III deficiency undergoing coronary bypass. A pharmacokinetic study in patients with hereditary AT-III deficiency indicated that the administration of the recombinant product resulted in an increase in blood... 

---