Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative
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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 Detection of Bacteria and Viruses in Bioprocess Samples: Justification, Regulation, Requirements and Technologies — How Can Industry Achieve Broad Adoption?
RAPID DETECTION OF BACTERIA AND VIRUSES IN BIOPROCESS SAMPLES: JUSTIFICATION, REGULATION, REQUIREMENTS AND TECHNOLOGIES — HOW CAN INDUSTRY ACHIEVE BROAD ADOPTION? CONNECT COLLABORATE ACCELERATE TM 1 Contents 1.0 Executive summary .......................................................................................................................................................................... 6 2.0 Introduction ....................................................................................................................................................................................... 8 3.0 Current practices ............................................................................................................................................................................10 3.1 Sterility testing ............................................................................................................................................................................. 10 3.2 Mycoplasma testing .................................................................................................................................................................... 11 3.3 Virus testing .................................................................................................................................................................................. 13 4.0 Drivers for change ...........................................................................................................................................................................15 -
Lean Manufacturing in a High Containment Environment
IPT 32 2009 11/3/10 15:48 Page 74 Manufacturing Lean Manufacturing in a High Containment Environment By Georg Bernhard A case study of how Pfizer’s Right First Time strategy helped overcome at Pfizer Global daunting capacity challenges at its new large-scale containment facility Manufacturing at Illertissen, Germany, while Six Sigma and Lean strategies enabled the site to achieve previously unknown levels of efficiency. In late 2006, Pfizer launched its smoking cessation film-coated tablets. All of the process stages (granulation, product varenicline, known as Chantix® in the US tableting and coating) are controlled and monitored from and Champix® across Europe. According to IMS a separate control room so that employees do not come benchmarks, Champix® was the fastest product launch in into contact with dust that might be generated during the the European pharmaceutical industry, with marketing tablet production run. Transport is handled by automated, in 16 European countries in a five-month period. As well and entirely robotic, laser-guided vehicles. Operators as creating rapid and unprecedented consumer demand, monitor and control all containment room activities from the product launch also brought capacity challenges for a separate control room. Pfizer Inc’s small-scale IllertissenCONtainment (ICON) facility in Illertissen, Germany. The facility’s innovative IT systems integration enabled an extraordinary 85 per cent level of automation (LoA), A strategic site in Pfizer’s global manufacturing network, outstripping even the ICON facility’s extremely high 76 per Illertissen is focused on oral solid dosage forms and is a cent LoA. Thus, in NEWCON, all process sequences centre of excellence in containment production. -
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. -
Automationml 2.0 (CAEX 2.15)
Application Recommendation Provisioning for MES and ERP – Support for IEC 62264 and B2MML Release Date: November 7, 2018 ID: AR-MES-ERP Version: 1.1.0 Compatibility: AutomationML 2.0 (CAEX 2.15) Provisioning for MES and ERP Author: Bernhard Wally [email protected] Business Informatics Group, CDL-MINT, TU Wien AR-MES-ERP 1.1.0 2 Provisioning for MES and ERP Table of Content Table of Content .............................................................................................................................................. 3 List of Figures .................................................................................................................................................. 6 List of Tables .................................................................................................................................................... 7 List of Code Listings ..................................................................................................................................... 11 Provided Libraries .................................................................................................................. 12 I.1 Role Class Libraries ............................................................................................................................ 12 I.2 Interface Class Libraries ..................................................................................................................... 12 Referenced Libraries ............................................................................................................. -
Simple Strategies to Improve Bioprocess Pure Culture Processing
Reprinted from PHARMACEUTICAL ENGINEERING® The Official Magazine of ISPE May/June 2010, Vol. 30 No. 3 Pure Culture Bioprocessing www.ISPE.org ©Copyright ISPE 2010 This article presents Simple Strategies to Improve strategies to improve Bioprocess Pure Culture Processing bioreactions by reducing contaminations by Michael Hines, Chris Holmes, and Ryan Schad by adventitious agents. ioreaction and fermentation processes of traditional bioprocess reactors and fermenta- of all scales – from 100,000 liter vessels tion processes. They are targeted squarely for to small development reactors – require the practitioner in their simplicity, and based pure culture for their successful, pro- on many years of managing pure culture opera- Bductive operation. In this article the term “pure tions at many scales. The focus of this article culture” and “pure culture capability” will be is on preventing bacterial contaminations in used instead of “sterile” or “sterility assurance” traditional fermentation systems; much of the to acknowledge that bioreactions are, by nature, material applies to protection of any bioreactor the process of growing large populations of systems from any adventitious agent. It is up to helpful microorganisms or cells as opposed to you to understand your system and process and the more unwanted varieties. Contamination to appropriately apply the principles outlined in by adventitious agents costs time, money, and order to meet the requirements of your process lost productivity; moreover, contaminants and and business. Higher potential risk from longer their sources can be very difficult to locate and growth times, longer inoculum trains, and lack eliminate. of selective agents (e.g., antibiotics) can be offset Many elements of pure culture bioprocess through the use of disposables, newer equip- design and operation are straightforward, often ment, and more stringent environmental and even a matter of common sense. -
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. -
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. -
Bottom-Up Self-Assembly Based on DNA Nanotechnology
nanomaterials Review Bottom-Up Self-Assembly Based on DNA Nanotechnology 1, 1, 1 1 1,2,3, Xuehui Yan y, Shujing Huang y, Yong Wang , Yuanyuan Tang and Ye Tian * 1 College of Engineering and Applied Sciences, State Key Laboratory of Analytical Chemistry for Life Science, Nanjing University, Nanjing 210023, China; [email protected] (X.Y.); [email protected] (S.H.); [email protected] (Y.W.); [email protected] (Y.T.) 2 Shenzhen Research Institute of Nanjing University, Shenzhen 518000, China 3 Chemistry and Biomedicine Innovation Center, Nanjing University, Nanjing 210023, China * Correspondence: [email protected] These authors contributed equally to this work. y Received: 9 September 2020; Accepted: 12 October 2020; Published: 16 October 2020 Abstract: Manipulating materials at the atomic scale is one of the goals of the development of chemistry and materials science, as it provides the possibility to customize material properties; however, it still remains a huge challenge. Using DNA self-assembly, materials can be controlled at the nano scale to achieve atomic- or nano-scaled fabrication. The programmability and addressability of DNA molecules can be applied to realize the self-assembly of materials from the bottom-up, which is called DNA nanotechnology. DNA nanotechnology does not focus on the biological functions of DNA molecules, but combines them into motifs, and then assembles these motifs to form ordered two-dimensional (2D) or three-dimensional (3D) lattices. These lattices can serve as general templates to regulate the assembly of guest materials. In this review, we introduce three typical DNA self-assembly strategies in this field and highlight the significant progress of each. -
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. -
Implementation of Lean Six Sigma Methodology on a Wine Bottling Line
MASTER THESIS The implementation of Lean Six Sigma methodology in the wine sector: an analysis of a wine bottling line in Trentino Master Thesis in Industrial Engineering by Sergio De Gracia Directed by Prof. Roberta Raffaelli Academic Year 2013-2014 Table of Contents Abstract ......................................................................................................................................... 9 Acknowledgements ..................................................................................................................... 10 Introduction ................................................................................................................................ 11 Lean Manufacturing .................................................................................................................... 14 1. Lean Manufacturing ................................................................................................................ 14 1.1. TPS in Lean Manufacturing.......................................................................................... 15 1.2. Types of waste and value added ................................................................................. 16 1.2.1. Value Stream Mapping (VSM) ................................................................................... 18 1.3. Continual Improvement process and KAIZEN ............................................................. 19 1.4. Lean Thinking ............................................................................................................. -
Optimal Operation of an Integrated Bioreaction–Crystallization Process
中国科技论文在线 http://www.paper.edu.cn Chemical Engineering Science 56 (2001) 6165–6170 www.elsevier.com/locate/ces Optimal operation ofan integrated bioreaction–crystallization process for continuous production of calcium gluconate using external loop airlift columns Jie Baoa, Kenichi Koumatsua, Keiji Furumotob, Makoto Yoshimotoa, Kimitoshi Fukunagaa, Katsumi Nakaoa; ∗ aDepartment of Applied Chemistry and Chemical Engineering, Yamaguchi University, Tokiwadai, Ube, Yamaguchi 755-8611, Japan bOshima National College of Maritime Technology, Oshima, Yamaguchi 742-2106, Japan Abstract A kinetic model was proposed to optimize the integrated bioreaction–crystallization process newly developed for production of calcium gluconate crystals using external loop airlift columns. The optimal operating conditions in the bioreactor were determined using an objective function deÿned to maximize the productivity as well as to minimize biocatalyst loss. The optimization of the crystallizer was carried out by matching the crystallization rate to the optimal production rate in the bioreactor because the bioreaction was found to be the rate controlling process. The calcium gluconate productivity under the optimal conditions of the integrated process was obtained by the simulation based on the process model. The productivity ofthe proposed process was found to be comparable to that ofthe current batch fermentationprocess. ? 2001 Elsevier Science Ltd. All rights reserved. Keywords: Process kinetic model; Optimization; Calcium gluconate; Bioreaction–crystallization