05 Biomanufacturing Brochure Cxns.Indd
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Biomanufacturing Technology Roadmap
©BioPhorum Operations Group Ltd SUPPLY PARTNERSHIP MANAGEMENT BIOMANUFACTURING TECHNOLOGY ROADMAP SUPPLY PARTNERSHIP MANAGEMENT BPOG Technology Roadmap 1 ©BioPhorum Operations Group Ltd SUPPLY PARTNERSHIP MANAGEMENT Acknowledgments The following member company participants are acknowledged for their efforts and contributions in the production of this roadmap document. (* indicates non-member contributor) AstraZeneca Merck & Co. Inc., Kenilworth, NJ, USA Merck KGaA, Darmstadt, Germany Mike Kinley Adam Randall Kendall Nichols Bayer Pfizer Asahi Kasei Bioprocess Edgar Sur Jennifer Johns Kimo Sanderson Biogen Roche Thermo Fisher Scientific Dave Kolwyck Freia Funke Steve Gorfien Rhea Mahabir GSK Shire Iris Welch Alan Glazer BioPhorum Operations Group Mike McSweeney Alfred Keusch Bob Brooks Bela Green Janssen Avantor* Chris Calabretta Dave Lescinski* BPOG Technology Roadmap 2 ©BioPhorum Operations Group Ltd SUPPLY PARTNERSHIP MANAGEMENT Contents 1 Summary ..............................................................................................................................................................................................................5 2 Introduction .........................................................................................................................................................................................................6 2.1 Vision ....................................................................................................................................................................................................................................6 -
Rapid Vaccine Development & Biomanufacturing Using a Scalable
Rapid Vaccine Development & Biomanufacturing Using a Scalable, Non-viral Delivery Platform for Cell Engineering. James Brady, Weili Wang, Rama Shivakumar, Pachai Natarajan, Krista Steger, and Madhusudan Peshwa. MaxCyte, Gaithersburg, MD, USA. Abstract Researchers have looked to recombinant technologies to develop innovative types of vaccines and new cell culture-based means of production that offer shorter lead times and greater production flexibility while High Level Cell Viability and Transfection maintaining vaccine safety. Transient transfection offers a means of rapidly producing an array of proteins, Efficiencies including antibodies, vaccines, viral vectors, and virus-like particles (VLPs). Although a variety of transient transfection methods are available, most do not meet the requirements of scalability, consistency, and cell Figure 1. High Efficiency Transfection of Cell Types type flexibility for use in vaccine development and manufacturing. MaxCyte’s electroporation-based delivery Commonly Used for Protein and Vaccine Production. platform reproducibly transfects a broad range of biorelevant adherent and suspension cell types with high Various cells were transfected with 2 µg/1E6 cells of pGFP cell viabilities & transfection efficiencies using single-use processing assemblies for cGMP, “plug-and-play” DNA using the appropriate MaxCyte STX protocol. Cells production of recombinant proteins and vaccines. In this poster we present data for large-scale production were examined for GFP expression using fluorescence microscopy 24 hrs post electroporation (EP). of antibodies, recombinant antigens, VLPs, and lentiviral vectors using the MaxCyte STX® Scalable Transfection System. Data are presented for high-efficiency transfection of cells commonly used in protein production including CHO, HEK293, and insect cells--without the use of baculovirus--with a timeline of just a few days from plasmid to gram quantities of protein. -
Bioprocessing Asia 2018 Programme and Abstract Book
BPA BioProcessing Asia BioProcessing Asia 2018 Programme and Abstract Book Third International Conference LANGKAWI, MALAYSIA, 12–15 NOVEMBER 2018 Contents General Information 4 The BioProcessing Asia Conference Series 7 Scientific Advisory Committee 8 Sponsors 10 Programme 18 Poster list 24 Abstracts 26 Session 1 27 Session 2 30 Session 3 33 Session 4 37 Session 5 41 Session 6 45 Poster Session 7 49 Welcome to the Third International BioProcessing Asia Conference at the Langkawi International Convention Centre, Langkawi, Malaysia It is a great pleasure to welcome you to the third meeting in the BioProcessing Asia Conference Series. This Conference continues the trend set by the two previous BPA conferences in 2014 and 2016 in exploring themes and topics focused on the contribution of bioprocessing towards the development and manufacture of affordable biopharmaceutical products in Asia. Of particular importance at this conference is the contribution made by our Scientific Advisory Committee on the identification of specific current trends in the field. This input has led to the selection of six Oral Sessions that cover important aspects of bioprocessing ranging from disease treatments, innovations in technology, vaccine design and development, the changing environment of plasma products, disruptive manufacturing strategies and the evolving regulatory environment in Asia. These topics are further developed and explored in the Poster Session where, as in the past, more detailed discussions and the exploration of ideas without the usual constraints of time can be pursued. We are fortunate to have attracted several outstanding Keynote and Focus lecturers to the meeting including Dr Ashok Kumar, President of IPCA Ltd’s R&D Centre in Mumbai and Dr Subash Kapre, Director Emeritus at the Serum Institute of India and from Inventprise, USA, who, together with the distinguished Session Chairs will set the tone and lead the discussions on salient areas of bioprocessing. -
Orange Book Cumulative Supplement 7 July 2006
CUMULATIVE SUPPLEMENT 07 July 2006 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs 2006 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 26th EDITION Cumulative Supplement 07 July 2006 CONTENTS PAGE 1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Applicant Name Changes.................................................................................................................. iv 1.3 Availability of the Edition ................................................................................................................... vi 1.4 Report of Counts for the Prescription Drug Product List ................................................................... vi 1.5 Zocor (simvastatin) Patent Relisting.................................................................................................viii 1.6 Cumulative Supplement Legend ....................................................................................................... vi DRUG PRODUCT LISTS Prescription Drug Product List ...................................................................................................... -
Scale and High-Quality Human T Cells Production Jianfa Ou1, Yingnan Si1, Yawen Tang1, Grace E
Ou et al. Journal of Biological Engineering (2019) 13:34 https://doi.org/10.1186/s13036-019-0167-2 RESEARCH Open Access Novel biomanufacturing platform for large- scale and high-quality human T cells production Jianfa Ou1, Yingnan Si1, Yawen Tang1, Grace E. Salzer1, Yun Lu1, Seulhee Kim1, Hongwei Qin2, Lufang Zhou3 and Xiaoguang Liu1* Abstract The adoptive transfer of human T cells or genetically-engineered T cells with cancer-targeting receptors has shown tremendous promise for eradicating tumors in clinical trials. The objective of this study was to develop a novel T cell biomanufacturing platform using stirred-tank bioreactor for large-scale and high-quality cellular production. First, various factors, such as bioreactor parameters, media, supplements, stimulation, seed age, and donors, were investigated. A serum-free fed-batch bioproduction process was developed to achieve 1000-fold expansion within 8 days after first stimulation and another 500-fold expansion with second stimulation. Second, this biomanufacturing process was successfully scaled up in bioreactor with dilution factor of 10, and the robustness and reproducibility of the process was confirmed by the inclusion of different donors’ T cells of various qualities. Finally, T cell quality was monitored using 12 surface markers and 3 intracellular cytokines as the critical quality assessment criteria in early, middle and late stages of cell production. In this study, a new biomanufacturing platform was created to produce reliable, reproducible, high-quality, and large-quantity (i.e. > 5 billion) human T cells in stirred-tank bioreactor. This platform is compatible with the production systems of monoclonal antibodies, vaccines, and other therapeutic cells, which provides not only the proof-of-concept but also the ready-to-use new approach of T cell expansion for clinical immune therapy. -
Drug Delivery Technology Y
* DDT Nov-Dec 2007 Working 11/9/07 2:29 PM Page 1 November/December 2007 Vol 7 No 10 IN THIS ISSUE Company Profiles 12 Drug Delivery Technologies 58 Excipients, Polymers, Liposomes & Lipids 78 Contract Pharmaceutical & Biological Development Services 83 Machinery & Laboratory Equipment and Software 96 Technology Showcase 102 The science & business of specialty pharma, biotechnology, and drug delivery www.drugdeliverytech.com * DDT Nov-Dec 2007 Working 11/9/07 2:39 PM Page 2 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 3 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 4 November/December 2007 Vol 7 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Coming in 2008 Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Drug Delivery Weekly & Fax: (703) 548-3733 E-mail: [email protected] Specialty Pharma News E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] 0 The weekly electronic newsletter from the publishers of Drug 1 International o N Delivery Technology and Specialty Pharma will provide over 12,000 Ralph Vitaro 7 219 Changebridge Road l o subscribers with the latest news of business deals, alliances, and V Montville, NJ 07045 Tel: (973) 299-1200 7 technology breakthroughs from the pharmaceutical, specialty 0 Fax: (973) 299-7937 0 2 pharmaceutical, drug delivery, and biotechnology industries. -
So, What Is Biomanufacturing?
Bioscience Industry Fellowship Project 2014 Presentations S Table of Contents Example of Course Development for STEM Slides 3-14 Community College Instructors Heather King; Igor Kreydin What does “Boot Camp” mean? Slides 15-61 Julie Ellis; Ezekiel Barnes Recruitment Plan for Biosciences Slides 62-66 Scott Gevart; Daymond Lindell Bioscience Awareness: Using what we know to Slides 67-93 build for tomorrow’s sustainability Savitha Pinnepalli; Jude Okoyeh BIOSCIENCES INDUSTRY FELLOWSHIP PROGRAM JUNE 2-27, 2014 Example of Course Development for STEM Community College Instructors (Based on BIFP Experience) Heather King Igor Kreydin Developmental Math Instructor STEAM Instructor Forsyth Technical Community College, NC Roxbury Community College, MA [email protected] [email protected] Modern Industry 2012 Educational Profile for Biotechnology Employees in NC High School 4% High School plus Certificate 10% 17% Associates in Science or 13% Associates in Applied Science Bachelor of Arts or Science 43% 13% Master of Arts or Science Doctorate NCGE-North Carolina in the Global Economy Project, http://www.ncglobaleconomy.com/NC_GlobalEconomy/biotechnology/overview.shtml In every math class you will hear … Why do I need to know this? When will I ever use this? In every science class you will hear … Did I learn how to do this in my math class? Don’t Let Your Students Get Stuck Here. Make Math Relevant! Basic Mathematical Concepts Equations Proportions Ratios of Lines Percents Exponents Basic Biotechnology Solving Equations Statistics Applications Graphs Fractions Scientific Formulas Conversions Notation Expressions, Linear Equations & Inequalities Dilutions of Solutions Forsyth Technical Community College Suppose you have a stock TGS electrophoresis buffer solution that is used in a protein profiler investigation of fish. -
9894 Pharma Tech Media Planner V6 2007
www.pharmtech.com years 1977– 2007 30ANNIVERSARY CELEBRATING 30 YEARS AS THE 2007 INDUSTRY’S MOST AUTHORITATIVE SOURCE Media Planner years 1977–2007 ANNIVERSARY years 1977–2007 ANNIVERSARY THE PHARMACEUTICAL TECHNOLOGY BRAND PUBLISHER’S STATEMENT Pharmaceutical Technology’s authoritative reputation and powerful brand recognition within the pharmaceutical/biopharmaceutical development & manufacturing marketplace will help you establish and maintain your own strong brand among pharma industry decision makers. A circulation of 38,667 BPA-qualified subscribers* and unmatched peer written and reviewed editorial make Pharmaceutical Technology an invaluable resource within top pharma companies, as well as small, specialty and biotech pharma companies spending billions each year on pharmaceutical development and manufacturing. Please celebrate with us as Pharmaceutical Technology marks its 30th Anniversary as the industry leader. —Michael Tracey, Publisher % 90 of readers rated Pharmaceutical Technology as important or very important to them as a professionalˆ EDITORIAL MISSION Pharmaceutical Technology publishes authoritative, reliable, and timely peer-reviewed research and expert analyses for scientists, engineers, technicians, and managers engaged in process development, manufacturing, formulation, analytical technology, packaging and regulatory compliance in the pharmaceutical and biotechnology industries. —Douglas McCormick, Editor in chief www.pharmtech.com *BPA June 2006 Statement ^2006 Readership Study Conducted by Advanstar Research -
Careers in Biomanufacturing
mapping your future: EXPLORING CAREERS IN BIOMANUFACTURING An Educational Module for Middle School and High School Teachers and Students Prepared by the North Carolina Association for Biomedical Research under contract with the North Carolina Biotechnology Center July 2006 mapping your future: EXPLORING CAREERS IN BIOMANUFACTURING This educational module was prepared by: The North Carolina Association for Biomedical Research (NCABR) P.O. Box 19469 Raleigh, NC 27619-9469 919-785-1304 http://www.ncabr.org Contact NCABR to obtain additional copies. © 2006 North Carolina Association for Biomedical Research. All rights reserved. mapping your future: EXPLORING CAREERS IN BIOMANUFACTURING ACKNOWLEDGEMENTS INTRODUCTION UNIT I: BIOTECHNOLOGY AND ITS APPLICATIONS A. What is Biotechnology? . 4 B. Biotechnology Timeline. 5 Student Activity: Biotech Timeline . 7 C. Practical Applications of Biotechnology . 12 Student Activity: Create a Logo. 18 Student Activity: Make a Yeast Incubator . 20 Student Activity: DNA Extraction From Yeast . 24 UNIT II: FROM LAB TO MARKET: DRUG DISCOVERY AND MANUFACTURING A. How a New Drug Gets to Market — An Overview . 28 B. Clinical Trials — A Closer Look . 29 C. The Pharmaceutical and Biopharmaceutical Industries — Regulated for Safety and Quality. 31 Student Activity: New Drug Development . 33 D. Producing a Pharmaceutical or Biopharmaceutical — The Manufacturing Process. 38 E. What Quality Means and Why It Matters . 39 F. Standard Operating Procedure (SOP) and Regulations . 41 Student Activity: Say What You Do and Do What You Say. 42 UNIT III: BIOMANUFACTURING CAREER OPPORTUNITIES A. Biotechnology Generates Opportunities . 48 B. Seizing the Opportunity . 49 C. On the Job — Typical Biomanufacturing Job Positions . 50 Student Activity: A Day in the Life of Six Biomanufacturing Employees . -
Audit Final Pn 5-28-04
Appendix Radio Radio Callsign Service Licensee State Callsign Service Licensee State KA26590 IG MDOI INC TX KA96512 IG PM REALTY GROUP TX KA2774 PW OXFORD, VILLAGE OF MI KAA245 IG YELLOW & CITY CAB CO KS KA3917 IG SCRANTON TIMES PA KAD598 PW RED OAK VETERINARY CLINIC IA KA40009 IG GADSDEN, CITY OF AL KAE933 IG FOODSERVICE MANAGEMENT GROUPFL INC KA40058 IG HOUMANN, JIM:HOUMANN, CHETND KAG551 PW COOK, RICHARD L MO KA42246 IG HOUSTON FLEA MARKET INC TX KAH411 IG MIKE HOPKINS DIST CO INC TX KA42563 IG MUIRFIELD VILLAGE GOLF CLUBOH KAH535 PW CEDAR RAPIDS, CITY OF IA KA4305 IG CITY OF LOS ANGELES DEPARTMENTCA OF KAJ418WATER & POWERIG KOPSA, LEO E IA KA43600 IG SHAPLEY, CHARLES P MO KAM394 IG CROOKSTON IMPLEMENT CO INCMN KA48204 PW PRESQUE ISLE, COUNTY OF MI KAM826 IG AIRGAS SOUTHWEST INC TX KA52811 IG R & R INDUSTRIES INC MA KAM951 IG TERRA INTERNATIONAL INC IA KA53323 IG ELK RIDGE LOG INC WA KAM983 IG RAY KREBSBACH & SONS IA KA53447 PW PIERCE, TOWNSHIP OF OH KAN247 IG BROCE CONSTRUCTION CO INCKS KA53918 IG B M I INC MI KAN892 PW HIAWATHA, CITY OF KS KA61058 IG THISTLE, RONALD F MA KAO274 IG MALINE, THOMAS G NE KA62473 PW KENTUCKY, COMMONWEALTH OFKY DBA KYKAP406 EMERGENCY MANAGEMENTIG DYNEGY IT INC TX KA64283 IG SAINT MARY MEDICAL CENTERWA KAP554 IG AWARE OPERATING SERVICES TXINC KA64769 IG SOUTHERN WAREHOUSING & DISTRIBUTIONFL KAQ533 LTD PW CALIFORNIA, STATE OF CA KA65089 IG DUN & BRADSTREET NJ KAQ708 PW PENNSYLVANIA, COMMONWEALTHPA OF KA65696 IG PARSONS INFRASTRUCTURE &CA TECHNOLOGYKAR785 GROUP PW PIMA, COUNTY OF AZ KA66353 IG BALTIMORE MARINE -
Progress Report January 2009 – December 2011
North Carolina State University Professional Science Master’s Program Progress Report January 2009 – December 2011 The Graduate School College of Agriculture & Life Sciences College of Design College of Education College of Engineering College of Humanities & Social Sciences Poole College of Management College of Natural Resources College of Physical & Mathematical Sciences College of Textiles College of Veterinary Medicine First-Year College 1 Greetings From the UNC System PSM Director The Professional Science Master’s (PSM) Program is one of the University of North Carolina (UNC) System’s ways to close the existing skills gap in the workplace. Together with local employers, we design graduate education and training regimens to match employers’ needs. The UNC System has undertaken a collaborative effort to develop these new programs in key areas of importance to North Carolina’s local economies. I am pleased to report that NC State University now offers nine PSM programs. Several new programs are at various planning stages, and numerous new central resources and services are available or under way for these programs. A special milestone in 2010 was the establishment of the PSM Council at NC State University. Members of this group include faculty who direct PSM programs or are planning to offer them in the future. The PSM Council oversees new program development and determines the future strategy for the PSM programs at NC State University. Another important milestone was the award of a new UNC System grant from the Alfred P. Sloan Foundation and support from the UNC General Administration for multiple online tools. I am greatly indebted to the many employers, professors and students who contribute to the collective success of NC State University’s PSM programs. -
Oral Delivery Oct 06 18/1/07 20:19 Page 1
Oral Delivery Oct 06 18/1/07 20:19 Page 1 ORAL DRUG DELIVERY WHEN YOU FIND THE HOLY GRAIL www.ondrugdelivery.com Oral Delivery Oct 06 18/1/07 20:19 Page 2 “Oral drug delivery: when you find the Holy Grail” CONTENTS This edition is one in a series of sponsored themed publications from ONdrugDelivery Ltd. Each issue focuses on a specific topic within the field of drug delivery, and contain up to eight articles contributed Introductory comment by leaders in that field. Guy Furness 3 Full contact information appears alongside each article. Contributing companies would be delighted to hear Growing sales and new opportunities for oral from interested readers directly. ONdrugDelivery fast dissolve would also be very pleased to pass on to authors, or Dr Ian Muir answer as appropriate, any queries you might have in relation to this publication or others in the series. Cardinal Health 4-6 During 2007 ONdrugDelivery will be covering the following topics: From oral drug delivery technology to proprietary February: Transdermal delivery product development April: Pulmonary delivery Dr Anand Baichwal, Thomas Sciascia, MD June: Prefilled syringes Penwest Pharmaceuticals 7-10 August: Oral drug delivery October: Delivering injectables December: Nanotechnology in drug delivery Combination oral products: the time is now! Fred H. Miller To start a FREE subscription (pdf or print) to INNERCAP Technologies 12-15 ONdrugDelivery’s sponsored series, please contact ONdrugDelivery directly (details below) Combining technologies without compromise: taste masking + ODT + modified release Steve Ellul Eurand 16-19 Oral drug delivery: the Holy Grail To find out more about how your company can Ms Bavani Shankar participate in 2007, please contact ONdrugDelivery Emisphere Technologies 20-21 directly (details below).