Tag: <span>immunogenicity</span>

It appears that the state of the biotech industry continues to improve. We now have a licensed cellular therapy that Dendreon developed, and which has now been sold to another firm that thinks it can make and administer this prostate cancer vaccine more efficiently, plus provide a more effective product. There is also a viral gene vector that has been licensed in Europe, and an application for US licensing has been submitted. Then there is the licensed influenza vaccine that is made with baculovirus technology, plus a second baculovirus-derived flu vaccine that is near licensure. The two companies with these flu vaccines are now charging ahead with their baculovirus expertise to produce Ebola vaccines…

Biologics Production

Two cell disruption methods, mechanical and chemical, were applied for the recovery of a fusion protein named CIGB 550-E7, expressed on Escherichia coli grown in defined saline media. A comparison of the methods was done, and various operating parameters for each technique were optimized to obtain the maximum disruption efficiency and CIGB 550-E7 protein release. The mechanical disruption’s yield and recovery were 1.24 and 1.37 times higher than those obtained with chemical disruption. Modified conditions were assayed for the CIGB 550-E7 obtained by chemically defined media using the mechanical and chemical cell disruption methods.

Biologics Biologics Production Manufacturing Research

The recombinant protein alefacept (Amevive®) is an immunomodulator approved for the ­treatment of moderate to severe chronic plaque psoriasis. In phase 3 clinical studies, treatment of psoriatic patients with alefacept at a safe and well-tolerated dose caused ­meaningful reductions in psoriasis area and severity index and in physician global ­assessment scores as well…

Biologics Production

Several developing countries, including India and China, have young biopharmaceutical industries that have based much of their growth potential on the production of what are currently known as “biogeneric” products, or “bioequivalent” versions of biologics that have already been licensed in Western countries. With a disdain for foreign patents, an established philosophy of copying Western innovations, and success in generic pharmaceutical manufacturing, this approach appeared to be the logical way to build a biologic manufacturing industry. However, there are numerous problems with this development strategy. First and foremost is the inherent incompatability of the very concepts associated with biogeneric products…

Biologics Production Manufacturing