Updated May 1, 2000

Final Programme of
Plasma Protein Biotechnology Meeting 1999
March 27th - 30th

Saturday, March 27th, 1999, 08.00 - 09.00

08.00	Welcome and Introduction
Plenary Lecture Chairman; Jan Berglof
08.15	"Plasma Products - Where are we and where are we going?  Richard Walker, Bio-Products Laboratory, Elstree, UK. "Current trends and issues on plasma products will be reviewed. What has and is happening in the industry, facing the current shortages of IVIG and potential threats of TSE. The developments in both developed and developing countries, regulatory issues, new products and alternative products and therapies will give us plenty of demanding challenges in the coming years. The industry will certainly look different in five years from now."

Saturday, March 27th, 1999, 09.00 - 12.00

Session 1; Albumin Chairman; Po Shing Wah
09.00	(101)	Development of Human Serum Albumin - A Model Process For a Safe Plasma Product and Other Applications. Po-Shing Wah, Global Manufacturing Technology/Engineering, Baxter Immuno-Hyland, 4501 Colorado Blvd, Los Angeles, CA 90039. U.S.A.[165]
09.30	(102)	The Development of Recombinant Human Serum Albumin (rHSA). Kaoru Kobayashi*#, Takao Ohmura##,Yoshio Tsuda#, Norifumi Nakamura#, Kunihide Oka1#. #Yoshitomi Pharmaceutical Industries. Ltd., Osaka, Japan, ##Bipha corporation, Hokkaido, Japan {140]
10.00 Coffee Break
10.30	(103)	Chromatographic Albumin Production - Pilot Plant to Manufacturing Plant. Edward M. Smith*. Manufacturing Manager, Bioplasma Division, CSL Ltd. Melbourne, Australia[164]
11.00	(104)	Negatively-Charged Albumins: A Novel Class of Polyanionic Proteins With Potent Anti-HIV Activity. A.H.L. Koenderman, J. Over, P.M.P. Bruckwilder, E.J.S. Meulenhoff, H. Schuitemaker, J.G. Huisman, P.J. Swart#, M. Kuipers# & D.K.F. Meijer#, CLB, Sanquin Blood Supply Foundation, Plesmanlaan 125, 1066 CX Amsterdam, & #University Centre for Pharmacy, Section Pharmacokinetics and Drug Delivery, State University Groningen, Groningen, The Netherlands {124]
11.30	(105)	Development of Human Serum Albumin as a Microcapsular Delivery Vehicle for In Vivo Diagnostic and Hemostatic Applications. Sarah Middleton*, Andaris Limited, Nottingham, England.[151]
12.00 Lunch

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Sunday, March 28th, 1999, 08.00 - 12.00

Session 2; Coagulation Factors Chairman; Jan Over
08.00		Chairman´s Introduction: Development and Production of Coagulation Factor Concentrates: Threats or Opportunities? J. Over, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands
08.15	(201)	Evoluation of Coagulation Factor Concentrates: Biotechnological Breakthrough of Immunoaffinity Chromatography Using Monoclonal Antibodies. Sudhish Chandra*, Chin C. Huang, and Fred Feldman, Centeon L.L.C., P.O. Box 501, Kankakee, IL 60901, USA. [147]
08.40	(202)	Safety Issues of Nanotiv(R), a Nanofiltered Highly Purified Factor IX Concentrate. Anna-Lena Löf, Pharmacia & Upjohn, Plasma Products, SE-112 87 Stockholm, Sweden [150]
09.05	(203)	A novel immunopurified Factor IX concentrate (Nonafact) prepared employing a monoclonal antibody that distinguishes between intact and cleaved Factor IX. K. Mertens*, D.C. Schotanus, A. Sprenkels, M. Tissing, C.P.M. Oerlemans, R. Zoethout, O.J.M. Bos, and P.C. van Mourik, CLB, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands [145]
09.35 Coffee Break
10.00	(204)	Clinical Experience with a new Recombinant Factor IX in Previously Treated and Previously Untreated Patients with Hemophilia B. S. Courter*, G. White, A. Shapiro, M. Magill, D. Rodriguez and the Recombinant Factor IX Study Group; University of North Carolina, Chapel Hill, NC; Indiana Hemophilia and Thrombosis Center, Indianapolis, IN; Genetics Institute, Inc., USA. [135]
10.30	(205)	Evaluation of Neoantigen Generation in a New Plasma-Derived Factor VIII Concentrate, BIOSTATE™ J Kanellos* T.M. Martinelli, G. DeMaria and N.H. Goss, CSL Bioplasma, Broadmeadows, Australia. [129]
11.00	(206)	Development of an Optimal Freeze-Drying Cycle for rFVIII. D.Q. Wang,, Bayer corp., Berkeley, California, U.S.A. [122]
11.30	(207)	ReFacto Potency Assignment : Practical Implications for the Clinic. Neil Kirby, Ph.D., Genetics Institute, Inc., USA. [149]

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Sunday, March 28th, 1999, 19.00 - 22.20

Session 3; Immunoglobulins Chairman; Hanns-Ingolf Paul
19.00		Chairman´s Introduction
19.20	(301)	"IVIG, the driving force in the plasma fractionation industry". Roland Hagberg, Pharmacia & Upjohn, Plasma Products, SE-112 87, Stockholm, Sweden[166]
19.40	(302)	Plasma Fractionation based on chromatography and precipitation by Polyethylene Glycol and Caprylic Acid. Joergen Dam* , Karina A. Barington, Per Kaersgaard. HemaSure Denmark A/S, Sauntesvej 13, DK-2820 Gentofte, Denmark[157]
20.10	(303)	Development and Scale-up of a Production Scale Chromatographic Process for the Production of Human IgG Intravenous. W.R. Lebing*, D.C. Lee, A.O. Davis, C.E. Nixon, H.I. Paul, Bayer Corporation, Clayton, NC 27520 U.S.A.[104]
20.40 Coffee Break
21.10	(304)	Chromatographic Purification of Immunoglobulins. J. Bertolini*, J. Davies, J. Wu, K. Pritchard, G. Seneviratne, K. Stuckly, K. Fogarty, N.H. Goss, CSL Limited, Broadmeadows, Vic. 3047. [152]
21.40	(305)	Characterisation and Formulation Development of a New Liquid Intravenous Immunoglobulin: Vigam Liquid. John More, BioProducts Laboratory, Elstree, Herts, UK, WD6 3BX[133]
22.00	(306)	The Influence of Iodine on Virus Inactivation and Human IgG in Virus Inactivation Procedures Using Iodine. Shirley Miekka*, William Drohan, American Red Cross Holland Laboratory and Ingrid Drevin, Ulf Hellberg, Peder Bergvall and Jan H. Berglöf, Amersham Pharmacia Biotech AB, Uppsala Sweden.[154]

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Monday, March 29th, 1999, 08.00 - 12.00

Session 4; Pathogen Removal and Inactivation Chairman; Bernard Horowitz
08.00	(400)	Chairman’s remarks - lessons from PCR, limitations of models, human use information - B. Horowitz
08.20	(401)	Chromatographic Partitioning of Model and Relevant Blood Borne Viruses and of Immune Complexes of Relevant Viruses in the Manufacture of Albumin and Immunoglobulin. W. Adcock, M. Hattarki, C. Broumis, A. MacGregor, A. Johnston, E. Uren* and N. H. Goss, Research and Development, Bioplasma Division, CSL Limited, 189-209 Camp Road, Broadmeadows, Victoria 3047 [128]
08.40	(402)	Cofact(R), a double virus inactivated prothrombin complex concentrate. H.G.J. ter Hart, I.M.M. Prins-de Nijs, F.A.C. van Engelenburg, H. Hiemstra and J. Over*. CLB, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands [146]
09.00	(403)	Influence Of Irradiator Design On Protein Recovery And Virus Kill On Treatment Of Blood Derivatives With UVC, X. Wang, Z. Yim, D. Hammond, J. Hamman, B. Horowitz*, V.I. Technologies, New York, NY, U.S.A. [141]
09.20	(404)	Caprylate Incubation as a Second Viral Inactivation Step in the Manufacture of Chromatographic Albumin. A. Johnston, R. Fang, D.Johnstone, K. Stuckly, C. Lambert, E. Uren* and N. H. Goss. Research and Development, Bioplasma Division, CSL Limited, 189-209 Camp Road, Broadmeadows, Victoria 3047[127]
09.40	(405)	Microwave Heat Inactivation of Virus: Investigation on Resistance of Various Pharmaceutical Proteins Exposed to High Temperature Short Time Heat Treatment. Joachim K. Walter*, Bettina Heil, Uwe Striffler and Stanley Charm#, Dept. Biotechnical Production, Boehringer Ingelheim Pharma KG,D-88397 Biberach, #Charm Bioengineering, Malden, MA USA[119]
10.00 Coffee Break
10.40	(406)	Preparation and Transfusion of Single Units of Fresh Frozen Plasma (FFP) Treated With a Psoralen Viral Inactivation Process. Laurence Corash*, David Wages and Gary Wiesehahn, Cerus Corporation, Concord, CA. USA[132]
11.00	(407)	INACTINE™ – A Viral Inactivation Technology for Reducing the Infectivity of Plasma-Derived Proteins. S. Ackerman*, C. Edson, A. Purmal, Q-X. Zhang, & E. Budowsky. Pentose Pharmaceuticals, Inc., Cambridge, Massachusetts, USA. [105]
11.20	(408)	Partitioning of TSE Agent(s) during Ethanol Fractionation of Human Plasma. Maring, J.-A.; MacAuley, C.‡; Theisen, P.W.‡; Dunston, B.‡; Stefansiko, K.‡; Adams, E.J.‡; Rentsch, M.; Rohwer, R.G.‡; Morgenthaler, J.-J.*; Red Cross Foundation Central Laboratory, BTS SRC, Bern, Switzerland, and ‡Molecular Neurovirology Unit, Medical Research Service, Veterans Affairs Medical Center, University of Maryland, Baltimore, U.S.A. [120]
11.40	(409)	Development and Application of a Sensitive Western Blot Assay to Measure PrPRES Partitioning During Plasma Fractionation. D. Lee#*, C. Stenland#, L. Ford#, R. Hartwell#, K. Gilligan#, J. Cheshire#, R. Rubenstein‡, R. Kascsak‡, M. Fournel#, and S. R. Petteway,Jr#. #Bayer Corporation, Research Triangle Park, NC and ‡NYS Institute for Basic Research in Develop-mental Disabilities, Staten Island, NY. [103]
12.00  Lunch

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Monday, March 29th, 1999, 19.00 - 22.00

Session 5; Regulatory Perspectives Chairman; Albert Farrugia
19.00	(501)	Current trends in plasma fractionation - a regulator's view. Albert Farrugia, Head, Blood Products Group, Therapeutic Goods Administration, Australian Commonwealth Government[142]
19.30	(502)	Prevention of Infections by Blood Products: Recent Recommendations of the German National Advisory Committee "Blood". Reinhard Burger, Robert Koch Institute, Berlin, Germany and German Natl. Advisory Committee "Blood"[102]
20.00	(503)	Regulation of New Technologies. Clive Morris, Molecular Biology Section, TGA Laboratories, PO Box 100, Woden ACT 2606 [118]
20.30 Coffee Break
21.00	(504)	Current Perspective on Recombinant Plasma Products - a Regulator's View. Rainer Seitz, MD, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, D-63225 Langen, Germany[125]
21.30	(505)	Perspectives on Novel Frameworks for Regulation of Bioengineered Products. P. R. Ganz*, E.S. Tackaberry, A. K. Dudani and A. Ridgway, Bureau of Biologics and Radiopharmaceuticals, Therapeutic Products Programme, Health Canada and Faculty of Medicine, University of Ottawa. [148]

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Tuesday, March 30th, 1999, 08.00 - 12.00

Session 6; Fibrin Sealants Chairman; William Drohen and Martin MacPhee
08.00		Chairman´s Remarks: Fibrin Sealant: Today and Tomorrow.
08.30	(601)	Clinical Trials with Fibrin Sealant. Sandra Burks, B.S.N., Heidi Flanagan, B.S.N., Gwo-Jaw Wang, M.D., Charles Gross, M.D., Thomas Daniel, M.D., Marcia Moore, M.D., Ph.D., and William Spotnitz, M.D.* Departments of Orthopedics, Otolaryngology, and Surgery , and The Tissue Adhesive Center, University of Virginia Health System, Charlottesville, Virginia.[162]
09.00	(602)   (603)	Ex Vivo Porcine Arteriotomy Assay: A Functional Assay for Characterizing A Fibrin-Sealant Bandage. Lathrop, J.T.*, Chihos, T. J., Tuthill, D., Friedman, S., Davis-Bruno, K., Rudnicka, K., Beall, D., and MacPhee, M., American Red Cross Holland Laboratory, Rockville, Maryland, U.S.A. [137] and An Arterial Hemorrhage Model in the Rabbit for the Assessment of Topical Hemostatic Agents. David Tuthill*, Vladislav Bayer, Anne Gallagher, Dawson Beall, William Drohan, and Martin MacPhee. American Red Cross Holland Laboratory, Rockville, Maryland, U.S.A.[139] A Combined Communication, Presented by Martin MacPhee
09.30	(604)	Infection Control Using Low Solubility Antibiotics in Fibrin Sealant. Christopher J. Woolverton1, William Drohan2 and Martin MacPhee2 , 1Department of Biological Sciences, Kent State University, Kent, OH 44242, USA and 2Holland Laboratory, American Red Cross, Rockville, MD 20855 USA.[153]
10.00 Coffee Break
10.30	(605)	Fibrin Dressings Reduce Blood Loss and Improve Survival in Hypothermic, Coagulopathic Swine with Grade V Liver Injuries. JB Holcomb MD*,1 AE Pusateri PhD,1 RA Harris DVM, MS,1 TJ Reid MD, PhD,2 JR Hess MD, MPH,2 MJ MacPhee PhD,3 1Ft. Sam Houston, TX, 2Wash, DC, 3American Red Cross, Rockville, MD. [158]
11.00	(606)	Use of the Absorbable Fibrin Adhesive Bandage (AFAB) to Facilitate Renal Reconstruction. Rhonda Cornum PhD MD*, Allen Morey MD, Richard Harris DVM, Vincent Gresham DVM, Ward Knight MD, John Holcomb MD and Anthony Pusateri PhD, Dawson Beall MS, and Martin MacPhee PhD. *Brooke Army Medical Center, San Antonio TX, USA [143]
11.30	(607)	Fibrin Sealant Foam Sprayed Directly on Liver Injuries Decreases Blood Loss in Resuscitated Rats. John B. Holcomb, MD* 1, Anthony E. Pusateri, PhD 1, L. Dawson Beall 2, MS, B. Bernadette Tock 2, MS, Richard A. Harris, DVM, MS 1, Martin J. MacPhee, PhD 2, John R. Hess, MD, MPH 3. -1Ft. Sam Houston, TX, 2 American Red Cross, Rockville, MD, 3 Washington, DC. [159]
12.00 Lunch

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Tuesday, March 30th, 1999, 13.00 - 17.00

Session 7; Other Therapeutic Products Chairman; Neil Goss and Prabir Bhattacharya
13.00	(701)	New Plasma Products - Opportunities and Challenges. Neil H Goss*, CSL Bioplasma, Broadmeadows Australia and Prabir Bhattacharya*, Alpha Therapeutics, City of Industry, U.S.A.[130]
13.30	(702)	Development of an Universal Solvent-Detergent Treated Plasma. Sing Chin, Maureen Brogan-Kim, Eleanor Chimezie, Bernard Horowitz, David Hammond* VITEX, New York, USA.[138]
14.00	(703)	Therapeutic Use of Plasma Apotransferrin for Protection Against High-Dose Chemotherapy-Induced Toxicity and Susceptibility to Infections. J. Parkkinen*, L. v. Bonsdorff, F. Ebeling, L. Sahlstedt#, T. Ruutu#, Finnish Red Cross Blood Transfusion Service (FRC), Kivihaantie 7, FIN-00310, Helsinki, Finland and #Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland [131]
14.30	(704)	Co-Purification of Superoxide Dismutase and Transferrin with Albumin from Hemolysate from Human Placenta. E.A.L. Martins*, V.M. Gonçalves, A.P.Y. Lopes, A.R. Carvalho, I. Raw, J. Cabrera-Crespo , Instituto Butantan: Centro de Biotecnologia. [121]
15.00 Coffee Break
15.30	(705)	Development of a Purification Process for AT-III Integrating Two Virus Clearance Steps. Bo Arve*, Subir Basak, and Hanns-Ingolf Paul, Bayer Corporation, Clayton, NC 27520, USA [134]
16.00	(706)	Cetor(R), A New C1-Inhibitor Concentrate and Its Use For Treating HAE Type I and AML. A.H.L. Koenderman*, H. Hiemstra, J. Over, H.W. Eijkhout, M.H. Tissing, C.E. Hack, A. Kleine#, W.Th. Hermens# & P.W.F. Strengers. CLB, Sanquin Blood Supply Foundation, Plesmanlaan 125, 1066 CX Amsterdam, & #Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands [123]
16.30	(707)	Development of PHP, a Hemoglobin-Based Therapeutic. Vipin K. Garg, Apex Bioscience Inc., USA [163]

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Saturday - Tuesday

Posters
(801)	Optimising Human Serum Albumin Production by Column Chromatography in a Blood Transfusion Service. S. Marrs, The South Blood Transfusion Service. [160]
(802)	Fractonation of Human Plasma to Obtain Albumin by the Combined Method of Cohn and Liquid Chromatography. K.Tanaka, E.Sawatani, G.A.Dias*, E.M.Shigueoka, F.Arashiro, T.C.X.B.Campos and H.C.Nakao. Division of Industrial Production and Development. Fundação Pró-Sangue Hemocentro de S.P., Av. Dr. Enéas de Carvalho Aguiar, 155 1o andar. CEP 05403-000 São Paulo-SP, Brasil.[117]
(803)	One-Step Ionic Chromatographic Purification of Human Albumin and Transferrin from Cohn Fraction IV. Jianhua Wang & Daoming Ni, No.1 Laboratory, Beijing Sai-Yin-Si Institute of Bio-technology, National Vaccine and Serum Institute, Beijing, 100024, P. R. China[115]
(804)	Albumin Production by Chromatography and Clinical Use. Olga Todorovska Damevska*, D. Ivanovski, P.Kolevski, V. Stefanovska, , Institute of Blood Transfusion, Plasma Fractionation, Skopje, Macedonia [101]
(805)	Study of Radial Flow & Axial Flow Process Columns for Protein Fractionation by Large Scale Chromatography. Sumant S. Karnik* , Vilas Baikar & Cyrus Boomla, National Plasma Fractionation Centre, Mumbai, Maharashtra, India[107]
(806)	Production and Efficiency of the Application of Human Rabies Immunoglobulin in the National Blood Transfusion Institute. Medic P.*, Tomovic O., Romic M., Gligorovic V., Popovic M., Pelevic S., Lalosevic D.1, Stankov S. 1, National Blood Transfusion Institute, Belgrade, Yugoslavia, 1Pasteur’s Institute, Novi Sad, Yugoslavia[126]
(807)	Intragam®P, a Double Viral Inactivated Intravenous Immunoglobulin Preparation In Patients With Primary Immune Deficiency. Fogarty K1*, Davies J1, Kemp A2, Gillis D3, McLachlan A4, Downs K5, Intragam®P Clinical Study Group§, 1CSL Limited Bioplasma Division, Broadmeadows, VIC 3047. 2Royal Childrens Hospital, VIC 3052. 3Institute of Medical and Veterinary Science, SA 5000. 4University of Sydney, NSW 2006. 5Datapharm Australia, NSW 2046.[161]
(808)	Purification of Human IgG by Chromatographic Method From the Precipitate F-I+II+III of Cohn Method. K. Tanaka, E. Sawatani*, G.A. Dias, E.M. Shigueoka, T.C.X.B. Campos, H.C. Nakao & F. Arashiro, Div of Industrial Prod and Devel, Fundacao Pro-Sangue Hemocentro de S.P., Av. Dr. Eneas de Carvalho Aguiar, 155 1o andar. CEP 05403-000 Sao Paulo- SP, Brasil. [110]
(809)	Stability Evaluation of Human Immune Globulin Intravenous (IGIV), 5% Solution. Rajesh Parti *, Meg Silva, Jesse Ardosa., Hyland Immuno Division, Baxter Healthcare Corporation 1720 Flower Avenue, Duarte, California, USA[114]
(810)	Use of High Resolution Techniques for Process Development and Quality Control in Production of Plasma Proteins. K. Löster*, Ch. Kannicht*, P. Schulz**, A. Buchacher**, K. Pock**, H. Schwinn** and Dj. Josic**, *Octapharma - Laboratory, Institute of Molecular Biology and Biochemistry, Arnimallee 22, D-14195 Berlin, GERMANY. **Octapharma, Oberlaaer Str. 235, A-1100 Vienna, Austria[155]
(811)	Production and Characterization of a new developed Factor IX Concentrate. A. Buchacher, L. Hoffer, K. Pock, K. Linnemayr, P. Schulz, H. Schwinn* and Dj. Josic, OCTAPHARMA, Oberlaaer Str. 235, A-1100 Vienna, Austria.[156]
(812)	In Vivo Analysis Of Packed Red Blood Cells Treated with S-303 to Inactivate Pathogens. D. Cook,* A. Stassinopoulos, S. Wollowitz, Y. Singh, M. Schott, F. Wang, R. Alfonso, C. Lin, A. Reames, K. DuPuis, L. Corten, K. Ling, W. Liu, Y. Tran, J. Merritt, K. Johnson, T. McCullough, Cerus Corp, Concord, CA and Baxter Healthcare Corp, Round Lake, IL[136]
(813)	A Flexible Process to Produce a Double Virus Inactivated, High-Purity and Protease-Free Fibrinogen. L. De Wael, M. Di Giambattista, Th. Branckaert, P. Caillet# and R. Laub, Central Fractionation Department, Red Cross, Brussels and #Laboratory of Radiophysiology and Radiobiology, Université Libre de Bruxelles, Belgium. Communicated by J. Over, CLB, Amsterdam, The Netherlands. [144]
(814)	Implementation of Biotech/Pharmaceutical projects using a modular approach. Clas Wallenborg, Pharmadule AB, Nacka, Sweden [167]
(815)	Terminal Sterilization of Biological Therapeutics Stuart Jackson*, Randall S. Kent & Frans Peetoom, University of Alberta, Edmonton AB, Canada & Puresource, Inc., Bellevue, WA, USA [168]
(816)	Process for fhe Increase of Human Plasma Albumin Yield. Tomovic O.*, Medic P. Romic M., Pitasevic Lj. and Gligorovic V., National Blood Transfusion Institute, Belgrade, Yugoslavia [169]

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