Current Trends in Bioprocessing
This is an overview of major industry trends, including in the areas of biotherapeutics, production technologies, scale-up and plant design, and supply and demand of manufacturing capacity. Therapeutic antibody markets are growing at about 20% and products are increasingly antagonistic towards their therapeutic targets; these types of products typically require relatively more capacity than agonists due to higher dosing requirements. Trends in newer antibody-related therapeutics are also discussed. Production technology trends include disposables, microbioreactors, platform technologies, and controlled glycosylation in yeast. Regulatory views of scale-up, development timelines, and overviews of bioreactor and chromatography scale-up are given. Examples of scale-up issues are presented for cell culture and chromatography. Scale-up issues include nutrient effects and changes to media; glycosylation and deamidation product changes; and large-scale chromatography effects. Advantages of modular construction of biopharmaceutical facilities are presented. Modular construction will often increase upfront capital costs, but can lower overall project and organizational risk by delaying the build decision based on clinical or other strategic information. The BioProcess Technology Consultant approach to estimating future supply (bioreactor capacity) and demand (from biotherapeutics) is given along with projections of market dynamics. In general, industry capacity supply is expected to match industry demand out to 2010, but market variables, as shown in a Monte Carlo analysis, can result in large swings in capacity demand, particularly from biotherapeutics commanding the most capacity.