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28 | AUGUST 2014 | GENengnews.com | Genetic Engineering & Biotechnology News Over the next 5–10 years, biotechnology will face unique challenges related to innovation, regulation, and economics. The industry will attempt to overcome these challenges by de- veloping novel drug classes and continuously improving manufacturing operations. The threat from Asian manufacturers, particu- larly in biosimilars, means that companies will need to continue innovating to remain competitive. To gain a clearer view of the competitive land- scape, GEN consulted with Prof. Dr. Oscar- Werner Reif, member of the executive com- mittee and executive vp of R&D; at Sartorius Stedim Biotech. GEN What types of innovation do you foresee in molecular classes? Prof. Reif The immense range of drug targets accessible through biologics suggests that these molecules will, over the course of the next decade, come to dominate development pipelines. One emerging class is the biolog- ical-cytotoxic conjugate. These are proteins, usually monoclonal antibodies, to which cy- totoxic small molecules have been chemically linked. The antibody seeks the tumor, while the small molecule component destroys it. Radionuclides are also possible payloads, or in some instances an enzyme may be included to initiate a therapeutic biological process. Manufacturing these drugs will require new technology, which is currently the most signifcant hurdle to development and com- mercialization. Many very successful link- ing techniques have already been patented, which limits freedom of operation for devel- opers. There are also issues related to mol- ecule design and production, but we are very close to solving these problems. GEN How about cell therapies, gene therapy, and vaccines? Prof. Reif Cell therapy will soon face an exis- tential challenge, namely will anyone pay for it? Technical and regulatory hurdles exist as well. As usual, success depends on econom- ics. Gene therapy is even more problematic. Although some flings have occurred, I be- lieve these treatments will remain in the sci- entifc or investigative realm for the foresee- able future. Vaccine R&D;, however, remains vibrant and promising. We have already begun to see more complex vaccination methodologies in the form of single-shot multivaccines or combinatorial vaccines. Vaccines may also appear within the next few years for treating cancer directly. GEN How about innovation on the engineering and manufacturing fronts? Prof. Reif Everybody is of course talking about continuous processing, a fully integrat- ed, top-down process similar to what we see in other manufacturing or process industries. But I'm afraid I will never see such a process adapted to the manufacture of biological drugs within my lifetime. I know that sounds negative, but so many hurdles remain. What will probably occur is for individual unit operations to run in continuous mode, for example, perfusion cell culture. Bayer's manufacture of Factor 8 is an example of a commercial success. But even that process re- verts to batch mode at critical junctures, so it's really a hybrid process. Regulatory remains a hurdle for continu- ous processing, as regulators and companies 39,916,800 The myriad of possible synthesis combinations using our extensive selection of modifi cations 18 Number of years we've been industry leaders in manufacturing oligos 23 Average years of experience of our oligo scientists QUALITY DNA, RNA & MODIFIED OLIGONUCLEOTIDES trilinkbiotech.com/oligo Sartorius Stedim Biotech's Prof. Dr. Oscar-Werner Reif Discusses Signicant Emerging Trends Embracing the Innovation Imperative BIOPROCESSING Perspectives