The Challenges of Immunogenicity

One of the big issues facing biotherapeutics is potential for generation of unwanted immune response. Biologicals have a propensity to elicit immune responses as a consequence of many factors including being protein-based macromolecules. Immunogenicity is relevant for both proteins and peptides including those generated by recombinant DNA technology as well as synthetic peptides. For […]

Biotherapeutics Manufacturing

I’m attending the BioProcessing Network Conference (21-23 Oct 2014) in Melbourne this week. It’s got me thinking about the major changes to biotherapeutics manufacturing. One of these significant changes has come about as a consequence of increased yield; when the quantity of product increases from mg/L to g/L then the scale of manufacturing can […]

By |October 21st, 2014|Manufacturing|0 Comments

Method of Manufacture Changes for Biologicals/Vaccines

Biologicals, including the products of recombinant technology and traditional vaccines, are the product of living cells. Because of this, seemingly inconsequential changes, such as feed rate, pH, stirring rate or temperature can have a profound effect on the proteins, including antigens, which the cells produce. Therefore, although many changes to the method of manufacture […]

By |September 15th, 2014|Manufacturing|0 Comments