I wrote the cover article, “Future Factories for Manufacturing Flexibility”, for the current issue of Pharmaceutical Engineering about biopharmaceutical manufacturing. It came about from my interview with John Cox, executive VP of Pharmaceutical Operations and Technology at Biogen.
Biogen, a biotech company with 18 biopharmaceutical experimental therapeutic drugs in development, most of which are monoclonal antibodies (mAbs), is aiming to transform its manufacturing capabilities so it can produce the metric tonnes of product needed.
Cox wants to know how pharmaceutical manufacturing, which is driven by capacity constraints, existing and to-be-built pipelines and the risks of sinking capital into future projects, can embrace innovations to provide the mass of drug product required by the booming market for mAbs and other biologics.
What I found especially fascinating are the exponential improvements in production that have occurred in since 1980. Pharmaceutical product titers have followed a variation of Moore’s Law, increasing 1000-fold from their levels 35 years ago (0.01 g/L), with facilities now routinely hitting 10 g/L. While these increases are substantial, what is equally impressive is that the price per gram of product has fallen 200-fold in that time to a mere $50. Advancements in downstream processing have taken advantage of these high titers to bring about process yields of 3 g/L and more.
All of these advances in manufacturing of biopharmaceuticals are necessary to meet capacity needs. A large-scale plant today can cost roughly $1 billion and take five years to design, build and license by regulatory agencies for commercial production. Companies taking huge capital risks long before they know the product is going to get approved.
Read the whole article by clicking on the image above.