Journal of Bioscience and BioengineeringVOL. 108 No. S1, S21–S28, 2009

www.elsevier.com/locate/jbiosc

Abstracts

Section II Biopharmaceuticals Production

BP-K1

Functional modification of protein therapeutics and its impact onproduction technologies

Toshiyuki Suzawa

Kyowa Hakko Kirin Co., Ltd., Takasaki-shi, Gunma, Japan

This presentation overviews advantage and current progress offunctional modification of protein therapeutics and its impact onproduction technology in biopharmaceutical industry. Protein ther-apeutics, especially monoclonal antibodies, have made a rapidprogress since late 1990s and more than 20 antibody products havebeen marketed so far. Thanks to the remarkable breakthrough inproduction technology at very large cell culture facilities, these newproducts requiring high therapeutic doses have been positioned inpractical use. However, prohibitively high production cost can still bepushing medicinal expenses and be recognized as untenable aspects.To overcome this drawback, additional breakthrough will be essentialfor the future biopharmaceutical industry. One approach for reducingthe cost of goods is to reinforce productivity using existinginfrastructures. Since facility expansion and scale-up ration areapparently limiting factors, production titer in cell culture looks tobe one of the major focus in the recent R&D activities.

Another outstanding approach will be to improve biologicalfunction of themolecule to be developed. For example, POTELLIGENT(R)

technology provides an opportunity to bring monoclonal antibodytherapeutics with more than 100-fold higher antibody-dependentcellular cytotoxicity than the past conventional antibodies byeliminating fucose moiety of the N-type carbohydrates presented asa common structure of the molecule. As another example, modifica-tion of protein therapeutics using certain polymers like polyethyleneglycols as well as conjugation of certain drugs with antibodies canbring significantly improved properties to the molecules. If such animproved function could be added onto the therapeutics, they mayexert desired therapeutic efficacy even with quite smaller adminis-tration doses.

Once such an improved technology becomes practically available,manufacturing capacity can be significantly reduced and, therefore,very large facilities might not necessarily be required. Thus, functionalmodification technology may provide some potential cornerstonesimpacting on manufacturing costs of biopharmaceuticals in thecoming decades.

doi:10.1016/j.jbiosc.2009.08.097

BP-K2

Developing new technologies for continuous manufacturing ofrecombinant proteins: When to innovate? What are the barriers?What are the challenges?

Konstantin Konstantinov, Peter McDonnell, and Blair Okita

Genzyme Corporation, Framingham, MA, USA

Genzyme has developed and implemented several large scalecontinuous processes for manufacturing of therapeutic proteins andsynthetic molecules. While the corresponding technology platformshave evolved independently, there are multiple essential conceptsand approaches that are compatible. We will review these similaritiesand will explore the synergistic opportunities to bridge knowledge inthese two areas, including process design concepts, new technologies,and logistics.

doi:10.1016/j.jbiosc.2009.08.098

BP-O1

Rapid response bioprocessing of influenza vaccines

Nani Wibowo, Tania Rivera-Hernandez, Yuan-Yuan Fan,Cindy Chang, Yap Pang Chuan, Linda Lua, and Anton Middelberg

University of Queensland, Brisbane, Queensland, Australia

Influenza viruses continuously undergo variation (antigenic driftand antigenic shift) to evade the immune system of the host, whichmeans the composition of the pandemic virus is not known in advance(1). The bottleneck to mass immunization increasingly lies in the areaof product manufacture, and in particular the recovery and purifica-tion of product from an often complexmixture without causing loss ofproduct efficacy. Current vaccine manufacturing technology, whichbegins by making an infectious virus in embryonated chicken eggs orcell culture, is unable to quickly deliver a mass vaccine to thepopulation (2). It will take several months before enough vaccine isavailable even to protect personnel working in essential services. Ourobjective is to break the vaccine manufacturing bottleneck to enablefull immunization of the population using existing biomanufacturingcapability, within weeks of new strain identification, and without therequirement for high-level containment during manufacture.