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Presentations

SPEED TO IND: RISKS TO ACHIEVING AGGRESSIVE BREAKTHROUGH/FAST-TRACK PRODUCT TIMELINES

By: Susan Dana Jones Presented at: KNect365 BioProcess International West Conference, February 27-March 2, 2017. The pharmaceutical industry is highly motivated by financial incentives to advance product candidates into first-in-human trials quickly. The drive to get biopharmaceuticals into the clinic quickly often leads companies to use platform manufacturing processes that are sufficient to...

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Opportunities for Continuous Manufacturing in Biopharmaceutical Production

Thomas C. Ransohoff, M.S., Vice President and Principal Consultant at BPTC, gave a presentation entitled "Opportunities for Continuous Manufacturing in Biopharmaceutical Production" at the World BioPharm Forum 2016: Progress in Continuous Biomanufacturing, on June 28, 2016 held at Robinson College, Cambridge, UK. Tom's presentation focused the potential benefits of continuous manufacturing in the production of...

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Opportunities for Continuous Manufacturing in Biopharmaceutical Production

By: T. Ransohoff Presented at: World BioPharm Forum 2016: Progress in Continuous Biomanufacturing; 2016 Jun 27-28; Robinson College, Cambridge, UK The potential benefits of continuous manufacturing in the production of bio/pharmaceuticals have been well publicized as have the challenges in implementing these and other new technologies in the production of biopharmaceuticals. This presentation...

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The Future of Downstream Processing

By: H. Levine Presented at: PDA Annual Meeting: Achieving Manufacturing Excellence: Current Trends and Future Technologies in Bioprocessing; 2016 Mar 14-16; San Antonio, TX. During the past several years, there have been many significant improvements in the upstream processes for biopharmaceutical product manufacturing, leading to increasing attention on similarly improving downstream processes. Recent...

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The potential impact of biosimilars on biomanufacturing capacity

By: T. Ransohoff Presented at: IBC's Biopharmaceutical Development and Production Week; 2015 Mar 30-Apr 2; Huntington Beach, CA. The emergence of biosimilars has the potential to significantly impact the biopharmaceutical industry on a global basis. In order to assess the influence of biosimilars on the biopharmaceutical manufacturing capacity landscape, we analyzed biomanufacturing data in...

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The potential impact of biosimilars on the biopharmaceutical capacity landscape

By: T. Ransohoff Presented at: BioProcessing Asia; 2014 Nov 3-7; Langkawi, Maylasia Much has been written about the emergence of biosimilars and their potential impact on the biopharmaceutical industry as a whole. Similarly, trends in biomanufacturing and biomanufacturing capacity have been the subject of many thoughtful reviews and publications with opinions varying widely...

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Biopharmaceutical manufacturing: Meeting tomorrow’s demands today

By: H. Levine Presented at: Repligen Investor and Analyst Breakfast Event; 2014 Oct 16; New York, NY. Howard Levine, Ph.D., President and Principal Consultant, delivered an opening presentation on current and future trends in biomanufacturing during Repligen's investor and analyst breakfast event in New York, NY. [emaillocker id=23238][qbutton size='' style='' text='VIEW PRESENTATION' icon_pack='' fa_icon='' fe_icon='' icon_color=''...

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The economic impact of single-use bioreactors

By: Rick Stock, Ph.D. Presented at: BIO International Convention: BioProcess Theater: Upstream Processing; 2012 Jun 18-21; Boston, MA. While the up-take of single-use bioreactors in the biotech industry has been steady, a surprising amount of apprehension still exists surrounding their application and promised benefits. This presentation highlights the benefits of increased overall cost...

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Technology transfer of novel immunotherapy program: GVAX and CRS-207

By: Patti Seymour Presented at: IBC's BioPharmaceutical Development and Production Week; 2014 Mar 24-27; San Diego, CA. Aduro BioTech is developing novel and complex immunotherapeutics for the treatment of oncology and infectious disease indications. This talk describes a case study for the selection of CMOs and technology transfer for Aduro’s lead clinical immunotherapy,...

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Going beyond flexible single use facilities for achieving efficient commercial manufacturing

By: Howard L. Levine, Ph.D. (BPTC), Fritjof Linz (DSM Biologics), Detlev Szarafinski (Sartorius Stedim Biotech GmbH) Presented at: A webinar sponsored by DSM In recent years, dramatic improvements in product titer and yield in manufacturing operations, the development of more potent biopharmaceutical products such as antibody-drug conjugates, and the increased focus on developing...

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Quality considerations in early biopharma development

By: Sheila Magil, Ph.D. Presented at: Pfenex's Strategies for Accelerating Preclinical Development of Vaccines and Therapeutic Proteins seminar. 2013 Aug 20; Boston, MA. Many decisions made early in development of a biopharmaceutical significantly impact the quality of the final product. Quality input should not be limited to those activities which are cGMP activities....

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Economical approaches to meeting global demand for high value biopharmaceuticals

By: Howard L. Levine, Ph.D. and Susan Dana Jones, Ph.D. Presented at: Informa Life Sciences' Ninth Annual BioProcess International European Conference and Exhibition While biopharmaceutical products are the growth engine of today’s global pharmaceutical market, their high cost and foreign manufacture make them expensive and difficult to obtain in many emerging markets such...

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The potential for continuous chromatography in clinical manufacturing of biopharmaceuticals

By: Thomas C. Ransohoff Presented at: IBC Life Science’s Biopharmaceutical Development and Production Week: Methods and Molecules; 2013 Feb 26-Mar 1; Huntington Beach, CA. With the rapid advance of single-use bioreactors and other technologies enabling large-scale production of biopharmaceuticals using disposables, the demand for disposable-format downstream process technologies is increasing. The emergence of...

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Fill & finish supply chain management: Bringing together security of supply, cost efficiency, global effectiveness, and local convenience

By: Howard L. Levine, Ph.D. and Kevin Orfan Presented at: World Trade Group's Fifth Annual Biomanufacturing Summit 2013; 2013 Jan 28-30; San Diego, CA. Fill and finish supply chain management over a global network is challenging. However, by combining the convenience of local manufacturing with the security and access to a global supply...

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Biomanufacturing outsourcing trends

By: Patti Seymour Presented at: Valuation and Funding: How to Accelerate Value Creation in Biotech Start-ups by Managing the CMO Selection Process; 2013 Jan 10; San Francisco, CA The biopharmaceutical industry is growing rapidly and one third of all drugs currently in development are biopharmaceutical products. There is sufficient capacity to manufacture these...

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Strategic outsourcing for success

By: Howard L. Levine, Ph.D. Presented at: MassBio's MA CRO/CMO Forum: Improving Speed to Clinic Using External Sourcing; 2012 Nov 16; Cambridge, MA Outsourcing can be an effective tool in helping companies, large and small, accelerate their product development activities and move product candidates from the laboratory to the clinic faster. By employing...

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State of the Biosimilar Industry and Implications for Technology

By: Patti Seymour Presented at: Massachusetts Institute of Technology's Center for Biomedical Innovation’s Fifth Annual Biomanufacturing Summit; 2012 Nov 7; Cambridge, MA. The impending patent cliff for many high-value innovator biopharmaceutical products offers significant opportunities for the biosimilar industry, whose market is estimated to grow from $243 million in 2010 to $3.7 billion...

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GL-2045: Applying QbD to cell Line development for a product with complex tertiary structure

By: Susan Dana Jones, Ph.D. Presented at: Informa's 10th Annual Bioproduction Conference; 2012 Oct 24-25; Berlin, Germany Gliknik Inc. is developing GL-2045, a recombinant stradomerTM, for autoimmune diseases. It has demonstrated potent efficacy in numerous animal models. StradomersTM are recombinant compounds designed to improve on both pooled human intravenous immunoglobulin and also on...

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Utilizing just-in-time labeling to increase flexibility in clinical supplies

By: Patti Seymour Presented at: Informa's 10th Annual Clinical Trials Supplies and Packaging; 2012 Oct 23-24; Munich, Germany Effectively managing the supply chain is essential during clinical development, as any weak link can result in significant impairment to the quality of the drug, budgets and timelines. Supply chain complexity requires an in depth...

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The use of disposable technologies in biopharmaceutical purification processes

By: Thomas C. Ransohoff Presented at: 2012 American Association of Pharmaceutical Scientists Annual Meeting and Exposition; 2012 Oct 14-18; Chicago, IL. With the rapid advance of single-use bioreactors and other technologies enabling large-scale production of biopharmaceuticals using disposables, the demand for disposable-format downstream process technologies is increasing. While single-use capsule filters have been...

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Design and interpretation of accelerated stability studies of biologics

By: Sheila Magil, Ph.D. Presented at: Cambridge Healthtech Institute’s Bioprocessing Summit; 2012 Aug 20-23, Boston, MA. Accelerated stability encompasses more than just the examination of higher temperature conditions during standard stability studies. A key aspect of accelerated stability is forced degradation studies in which the drug substance or drug product is exposed to...

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Applying quality by design to vaccine development

By: Sheila Magil Presented at: Cambridge Healthtech Institute’s Seventh Annual Immunotherapeutics and Vaccines Summit; 2012 Aug 13-15; Boston, MA. Developing a vaccine using Quality by Design (QbD) principles provides a design space allowing more flexibility for the manufacturer. This presentation highlights how a QbD approach can provide a pathway for more efficient and...

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Develop and implement contingency plans to better prepare for unexpected events

By: Patti Seymour Presented at: CBI’s Biopharmaceutical Forum on Clinical and Commercial Supply Chain Excellence; 2012 Jul 24-25; New Brunswick, NJ. Whether getting drugs to a population during a natural disaster or pulling product from the shelves in response to a recall, biopharmaceutical companies must have alternate supply chain strategies in place for...

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Neither beast nor bird: addressing biomanufacturing challenges with new expression systems

By: Thomas C. Ransohoff Presented at: BIO International Convention; 2012 Jun 18-21; Boston, MA. Of the many different types of biomolecule expression systems that have been tried, mammalian, primarily CHO cell, and E coli systems have remained the mainstays of biologic manufacturing, accounting for nearly 90 percent of the systems that produce today’s...

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The future of bioprocessing: new processes, new technologies, new products

By: Howard L. Levine, Ph.D. Presented at: Informa Eighth Annual BioProcess International Europe; 2012 Apr 18-19; Prague, Czech Republic The bioprocessing industry is under incredible pressure to reduce the cost of biomanufacturing yet remain competitive in bringing new technologies, therapies and processes through development. These slides were presented as part of Dr. Levine’s...

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Global demand and utilization of mammalian cell culture manufacturing capacity

By: Howard L. Levine, Ph.D. Presented at: Informa Eighth Annual BioProcess International Europe; 2012 Apr 18-19; Prague, Czech Republic. In the past five years, technological advances in manufacturing processes, improvements in expression levels, widespread acceptance of single-use bioreactors, an increase in biosimilar development throughout the world, and consolidation in the pharmaceutical and biopharmaceutical...

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Biomanufacturing capacity for biosimilars: Is there enough?

By: Patti Seymour Presented at: Cambridge Healthtech Institute’s Third Annual BIOAnalytical Summit; 2012 Mar 19-22; Baltimore, MD The impending patent cliff for many high-value innovator biopharmaceutical products offers significant opportunities for biosimilar companies, whose market is estimated to grow from $243 million in 2010 to $3.7 billion by 2015 in the United States,...

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The changing landscape of mammalian cell culture manufacturing capacity

By: Howard L. Levine Presented at: Eighth Annual bioProcessUK Conference; 2011 Nov 30-Dec 1; Glasgow, Scotland Recent technological advances in manufacturing processes, improvements in expression levels, widespread acceptance of single-use bioreactors, an increase in biosimilar development throughout the world, and consolidation in the pharmaceutical and biopharmaceutical industries have resulted in significant changes in...

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Can continuous purification of biopharmaceuticals become a reality?

By: Thomas C. Ransoff Presented at: IBC’s 7th Annual Biopharmaceutical Manufacturing and Development Summit; 2011 Sep 12-14; San Diego, CA Most biopharmaceutical products are manufactured using “tried and true” batch processing methods, which are effective but inherently less capital-efficient than continuous processing methods. Adoption of continuous processing approaches presents challenges, including regulatory uncertainties...

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Global trends in mammalian cell culture capacity and biomanufacturing

By: Thomas C. Ransohoff Presented at: The Swiss Biotech Program at BioPharm America 2011 At the end of the 20th Century, biomanufacturing output was limited by factory capacity and process bottlenecks, so companies launched technology and process initiatives to improve productivity. Today, such improvements, as well as mergers and globalization, have produced overcapacity,...

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The Biomanufacturing Capacity Conundrum: Matching Supply and Demand Over Space and Time

By: Howard L. Levine, Ph.D. (BPTC®), William J. Fallon (Halozyme Therapeutics), Roger Lias, Ph.D. (Eden Biodesign), Parrish Galliher (Xcellerex) Presented at: A break-out session at BIO International Convention; 2011 Jun 25-28; Washington, D.C. At the end of the 20th Century, biomanufacturing output was limited by factory capacity and process bottlenecks, so companies launched...

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Challenges in the cGMP Manufacturing of hESCs: Lessons Learned From Monoclonal Antibodies

By: Howard L. Levine, Ph.D. Presented at: 17th Annual International Society for Cellular Therapy Meeting; 2011 May 18-21; Rotterdam, The Netherlands. Commercialization of hESC-derived therapies will require the development of appropriate policies, procedures, and processes to address the large-scale GMP manufacturing, quality, and regulatory challenges of successfully bringing these new products to market....

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A brief review on evolving cell culture based manufacturing processes & technology drivers over the past 25 years

By: Wolf Noe, Ph.D. Presented at: Cambridge Healthtech Institute Peptalk San Diego, CA, Jan 10-14, 2011 Biomanufacturing Summit San Diego, CA, Jan 24–25, 2011 4th Annual Bioinnovation Leaders Summit London, UK, Feb 21–22, 2011 This presentation includes an overview of the challenges and advancements in cell culture over the past 25 years, including a discussion...

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Performance by Design: Engineering Functionality into Biopharmaceutical Products

By: Susan Dana Jones, Ph.D. Presented at: Cambridge Healthtech Institute Peptalk San Diego, CA, Jan 10-14, 2011 Most cell line development technologies focus on obtaining high titers quickly with little to no attention paid to post-translational modifications and potential product heterogeneity. A more effective approach would be to use cells engineered to produce...

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Biomanufacturing Capacity: The Bottleneck Moves Downstream

By: Thomas C. Ransohoff Presented at: ISPE Annual Meeting Orlando, FL, Nov 7-10, 2010 The industry is struggling to rebalance upstream and downstream processing. Why and how? Implications on world capacity? Topics covered include: What is the status of capacity distribution and utilization within the biopharmaceutical industry? The industry is struggling to rebalance...

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The Use of Disposable Technology for Downstream Processing

By: Howard L. Levine, Ph.D. Presented at: Cambridge Healthtech Institute Immunotherapeutics & Vaccine Summit; Short Course: Single Use Systems (Disposables) for Vaccine Manufacture Cambridge, MA, August 16-19, 2010 With the rapid advance of single-use and disposable-format bioreactors and other technologies enabling rapid and efficient production of vaccines, the demand for disposable-format downstream process...

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A World of Biomanufacturing: Shortages or Global Glut?

By: Howard L. Levine, Ph.D. Presented at: the 6th Annual BioProcess International European Conference and Exhibition Vienna, Austria, May 19, 2010 A short time ago, biopharmaceutical companies bemoaned the manufacturing bottlenecks that slowed drug development and delayed commercialization expressing fear that there would be insufficient capacity to meet the demand for all biopharmaceutical...

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Predictive Technologies for Cell Line Development Enable Enhanced Manufacturability

By: Susan Dana Jones, Ph.D. Presented at: Cambridge Healthtech Institute Peptalk San Diego, CA, Jan 11-15, 2010 To maximize success in biopharmaceutical clinical development and commercialization, incorporating strategies to optimize manufacturability early in development is essential. New technologies enable accurate prediction of bioreactor productivity, product quality, and cell line performance at the early...

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Disposable Technologies for Purification of Biopharmaceuticals

By: Thomas C. Ransohoff Presented at: the NE Local Section SIM Meeting Boston, MA, December 14, 2009 With the rapid advance of single-use and disposable-format bioreactors and other technologies enabling large-scale production of biopharmaceuticals using disposable technologies, the demand for disposable-format downstream process technologies is increasing. While single-use capsule filters have been used...

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If You Build It, Will They Come? The Promise and Perils of Investing in Biomanufacturing Capacity

By: Thomas C. Ransohoff Presented at: the 2nd Annual Bernstein Biosimilars Conference New York, NY, November 19, 2009 With the increasing likelihood that health-care reform in the US will include a biosimilars regulatory pathway, there is increasing interest from a wide range of companies in the biosimilars market. Any new entrant into the...

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The Pros and Cons of Using Platform Approaches for Early Development of Monoclonal Antibodies: When Do We Deviate from the Platform?

By: James Blackwell, Ph.D., M.B.A. Presented at: IBC's Preclinical Scale Bioprocessing Boston, MA, November 3, 2009 Platform technologies are used by most organizations today in conjunction with product development. Deviating from the use of an organization’s standard platform requires consideration of the alternative’s rewards versus risks, the pros and cons of the alternative...

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Strategic Decisions and Risk Assessment in Production Cell Line Development

By: Susan Dana Jones, Ph.D. Presented at: BioDevelopment Summit, Optimizing Mammalian Cell Lines Conference, Cambridge Healthtech Institute Cambridge, MA, August 26-27, 2009 Many different approaches are available to develop high expressing mammalian cell lines for production of therapeutic proteins or antibodies. Decisions on which approach to use will be made based on whether...

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Challenges in Vaccine Production and Rapid Scale up to Meet Emerging Pandemic Threats

By: Susan Dana Jones, Ph.D. Presented at: BIO International Convention, Process Zone Theater, Atlanta, Georgia, May 20, 2009 Over 95 percent of US flu vaccine is manufactured in eggs. This provides ~50 million vaccine doses annually but requires 8-10 months. In a pandemic, more doses must be produced quickly and therefore rapid, scalable...

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Validation for the 21st Century

By: Alex D. Kanarek, Ph.D. Presented at: BIO International Convention, Atlanta, GA, May 21, 2009 The presentation explains and discusses the differences between the original FDA Guidance on Process Validation of 1978 and the new Draft Guidance issued in November 2008. The old approach to validation, including the preparation of, usually, three conformance...

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Best Practices In Ensuring Quality Standards When Outsourcing to Contract Manufacturers, Licensees and Consultants

By: Alex D. Kanarek, Ph.D. Presented at: the Strategic Institute’s Quality & Regulatory Strategies Summit, Toronto, ON, Canada, March 5, 2009 The presentation examines the qualification of a contractor and the responsibilities of contract givers and contractors of all types in compliance with quality standards and GxP practices. Emphasis is placed upon adequate...

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Challenges and Solutions for Biopharmaceutical Manufacturing

By: Howard L. Levine, Ph.D. Presented at: Cambridge HealthTech PepTalk Conference San Diego, CA, January 15, 2009 The biopharmaceutical industry is a dynamic one with many risks and uncertainties associated with product development and commercialization. The ability of a company to manufacture sufficient quantities of their product when they need it, whether for...

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Use of Critical Process Parameters and Quality by Design to Improve Biopharmaceutical Product Quality

By: Howard L. Levine, Ph.D. Presented at: 2008 PDA Development and Regulation of Clinical Trial Supplies Conference, Cambridge, MA November 11, 2008 IBC’s Bioprocess International Asia Pacific Conference, Mumbai, India October 21, 2008 Quality by Design in biopharmaceutical manufacturing processes includes the identification of critical process steps and parameters and the use of rational...

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Efficient Project Management of Outsourced Biopharmaceutical Development and Manufacturing Programs

By: Thomas C. Ransohoff and Howard L. Levine, Ph.D. Presented at: IBC's 5th Annual Early to Late Stage Bioprocess Development Summit, Boston, MA October 20, 2008 Efficient and cost effective biopharmaceutical development requires coordination of numerous activities, including cell line generation, process development, preparation of reference standard, analytical method development and qualification, stability...

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Effective Methods for Selection and Management of Contract Manufacturing Organizations (CMOs) for Biopharmaceutical Manufacturing

By: Susan Dana Jones, Ph.D. Presented at: IBC’s Bioprocess International Asia Pacific Conference, Mumbai, India, October 21, 2008 Companies must insure that the selected CMO has sufficient resources to develop a robust manufacturing process and to meet requirements of global regulatory authorities. The project should be closely managed through frequent meetings with the...

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Advances in Disposable-Format Downstream Processing Technologies

By: Thomas C. Ransohoff Presented at: BioProcess International Conference Anaheim, CA, September 23, 2008 With the rapid advance of single-use and disposable-format bioreactors and other technologies enabling large-scale disposable bioprocessing, the demand for disposable-format downstream process technologies is increasing. While disposable capsule filters have been used in biomaufacturing for decades, other downstream unit...

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Recent Trends in the Development and Manufacturing of Fusion Proteins as Therapeutics

By: Howard L. Levine, Ph.D., BioProcess Technology Consultants Jayant Aphale Ph.D., MBA, Enobia Pharma and Paul Kaladas, Ph.D., Laureate Pharma, Inc. Presented at: BioPharm International September 9, 2008 This webinar discusses the development and manufacturing of fusion proteins. Fusion genes are created by joining two or more genes each coding for separate proteins....

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Efficient Project Management of Biopharmaceutical Development: Insuring On-time and Compliant Development Programs

By: Howard L. Levine, Ph.D. Presented at: BIO Process Zone Theater, San Diego, CA June 17, 2008 The efficient and cost effective development and commercialization of biopharmaceutical products requires close coordination of numerous activities, including cell line generation, upstream and downstream process development, development of analytical methods for product characterization and release, identification...

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The Outsourcing Decision: Which Assays and Methodologies are Best to be Outsourced and Which Should be Developed Internally?

By: Sheila Magil, Ph.D. Presented at: BioProcess International Analytical and Quality Summit Cambridge, MA, June 2, 2008 The importance of analytical testing to biopharmaceutical manufacturing cannot be overemphasized. At all stages of development and production, analytical results impact processing decisions and the ultimate quality of your product. Decisions about outsourcing analytics are critical,...

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Challenges in Scaling Up Newly Developed Microbial Manufacturing Processes

By: Susan Dana Jones, Ph.D. Presented at: BIO Process Zone Theater San Diego, CA, June 20, 2008 This presentation describes an approach that can save time and money for companies developing unique products expressed in microbial systems. The approach streamlines development and scale up of a microbial manufacturing process. Usually, biopharmaceutical manufacturing processes...

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Interactive Panel Discussion—Challenges and Opportunities in Using BioSMB™ or other Multi-Column Approaches for Downstream Processing

By: Thomas C. Ransohoff Presented at: the IBC Antibody Production Conference San Diego, CA, March 13, 2008 Panel members: Jorg Thommes, Biogen Idec; Tim Tressel, Amgen; Marc Bisschops, Tarpon Biosystems; and Pete Gagnon, Validated Biosystems. Topics: What is the impact of a SMB process step on product quality? What are the opportunities for an...

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The Use of Critical Process Analysis to Reduce Risk and Increase Biologics Product Quality

By: Howard L. Levine, Ph.D. Presented at: FIP Quality International 2007 Conference London, UK, November 27, 2007 Quality by Design in biopharmaceutical manufacturing processes includes the identification of critical process steps and parameters and the use of rational design to reduce risk and increase product quality. Unlike traditional pharmaceutical products, the manufacture of...

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From Target to Clinic: Reduce the Time to Your First Important Milestone

By: Howard L. Levine, Ph.D. Presented at: the BIO-Europe 13th Annual International Partnering Conference Hamburg, Germany, November 12-14, 2007 This presentation includes an overall timeline and budget for biopharmaceutical development and a "best in industry" accelerated timeline. It also covers early steps in product development based on clone generation and transient expression using...

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The Ever-Changing Landscape of Biopharmaceutical API Outsourcing

By: Thomas C. Ransohoff, Senior Consultant, BioProcess Technology Consultants Presented at: DCAT/ISM/ICIS Strategic Sourcing Summit & Showcase New Brunswick, New Jersey, October 24, 2007 Manufacturing biopharmaceutical APIs present a range of technical and commercial challenges. The contract manufacturing segment of the biopharmaceutical industry has changed dramatically over the brief history of the biopharmaceutical...

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Strategies for CMC Excellence: Playbooks for Product Development from First in Human through Commercialization

By: Patricia Seymour, M.B.A., BioProcess Technology Consultants and Eric Emery, PDL BioPharma, Inc. Presented at: the IBC Antibody Development and Production Event Carlsbad, California, February 28, 2007 To streamline product commercialization and enable rapid product development, PDL and BioProcess Technology Consultants assembled Playbooks describing CMC activities from First in Human clinical trials through...

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The Future of Viral Validation

By: Howard L. Levine, Ph.D. Presented at: IBC Process Validation for Biologicals Conference Carlsbad, California, February 26-27, 2007 Viral safety of biologic products continues to be a major concern of regulatory agencies worldwide. New trends in the conduct of viral clearance studies and the assessment of viral safety will be presented. [emaillocker id=23238][qbutton size=''...

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Evaluating Strategic Options for Biomanufacturing: Build vs. Buy vs. Acquire

By: Thomas C. Ransohoff Presented at: IBC Biopharmaceutical Manufacturing and Development Summit Orlando, Florida, December 5-6, 2006 This presentation reviews the many factors that must be considered in developing a comprehensive manufacturing strategy against the backdrop of the current industry-wide supply and demand situation for biomanufacturing capacity. In addition to suitability and availability...

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Finding the Right Partner to Fit Your Outsourcing Needs

By: Patricia Seymour, M.B.A., BioProcess Technology Consultants, and Jason Bertola, Carbogen-Amcis Presented at: IQPC 4th Annual Contract Manufacuring Forum San Diego, California, May 24, 2006 Whether you are outsourcing out of need or to supplement internal capacity, selecting the right partner, managing the risk, and monitoring performance are critical components of the process....

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Current Trends in Bioprocessing

By: James Blackwell, Ph.D., M.B.A. Presented at: American Institute of Chemical Engineers Boston, Massachusetts, April 6, 2006 This is an overview of major industry trends, including in the areas of biotherapeutics, production technologies, scale-up and plant design, and supply and demand of manufacturing capacity. Therapeutic antibody markets are growing at about 20% and...

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The Impact of the EU Clinical Trials Directive and Other Recent Regulatory Changes on PD and the Manufacture of Biopharmaceuticals

By: James Blackwell, Ph.D., M.B.A. Presented at: ISPE Tampa, Florida, February 20, 2006 This presentation contrasts the 2006 FDA GMP regulations in support of Phase 1 clinical trials with the effect of the European Union’s Clinical Trial Directive (EU CTD) on biopharmaceutical manufacturing strategies and costs. For Europe, the costly compliance issues now...

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Successfully Managing Biopharmaceutical Manufacturing Outsourcing

By: Patricia Seymour, M.B.A. Presented at: IQPC 4th Annual Contract Manufacuring Forum — Workshop San Diego, California, May 22, 2006 Much has been written about the advantages of outsourcing biopharmaceutical development activities that are either not accessible internally or are not a core competency of the organization, such as manufacturing. While enlisting qualified...

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Mycoplasma — Recent Developments in Detecting and in Preventing Bioreactor Contamination

By: James Blackwell, Ph.D., M.B.A. Presented at: ISPE Annual Meeting Scottsdale, Arizona, November 6-10, 2005 In this presentation, the implications of mycoplasma contamination on cell culture companies are discussed along with two primary means used to reduce risk of contamination in large scale operations — heat treatment and media filtration. The biology and...

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The State of Biomanufacturing Capacity – Do We Finally Have Enough?

By: Howard L. Levine, Ph.D. Presented at: IBC’s BioProcess International World Conference and Exhibition Boston, MA, September 19, 2005 As development commercialization of new biopharmaceutical products continues, BioProcess Technology Consultants has updated its in-depth analysis of the supply and demand for biomanufacturing capacity. This analysis indicates demand for cell culture manufacturing capacity will...

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The Use of Disposable Technologies in Downstream Processing of Biopharmaceuticals: Current and Future Trends

By: Tom Ransohoff Presented at: IIR Biopharmaceutical Production Conference San Francisco, CA, July 22, 2005 The successful adoption of buffer and media bag systems and disposable bioreactor technologies by many biopharmaceutical firms in pilot and commercial manufacturing operations has increased interest and awareness in these technologies. However, the full benefits of adopting disposable...

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Impact of European Union Clinical Trial Directive (EU CTD) on Cost of Manufacturing Products for Clinical Trial

By: Susan Dana Jones, Ph.D. Presented at: BIO 2005 Philadelphia, PA, June 22, 2005 This presentation focuses on the effect of the European Union’s Clinical Trial Directive (EU CTD) on biopharmaceutical manufacturing strategies and costs. New and costly compliance issues now face companies wishing to conduct clinical trials in Europe, and these higher...

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Ensuring Complete and Efficient Process Validation Within a CMO-Sponsor Relationship

By: Howard L. Levine, Ph.D. Presented at: IBC’s International Biopharmaceutical Outsourcing, Contracting, and Partnering Conference: Discovering & Enhancing Strategic Options in Biomanufacturing San Diego, CA, March 8, 2005 When companies outsource process development and manufacturing, ensuring that process validation does not fall through the cracks becomes important. Some process validation studies must be...

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Managing Vendor Selection through the RFP Process

By: Susan Dana Jones, Ph.D. Presented at: IBC’s International Biopharmaceutical Outsourcing, Contracting, and Partnering Conference: Discovering & Enhancing Strategic Options in Biomanufacturing San Diego, CA, March 7, 2005 Many of the activities that encompass biopharmaceutical development can be outsourced to qualified CMOs. Selection of appropriate CMOs for each activity is critical to successful...

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