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BioPharma Asia Magazine

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  • Platform tech development for biosimilar upscaling
    Platform tech development for biosimilar upscaling Dr Hung Fai Poon, President, QuaCell Biotech Ltd and Floris De Smet, Sartorius Stedim Biotech Recorded: Jun 21 2018 68 mins
    Discover strategies to move candidate molecules through development
    Building consistent, straightforward processes with low variability
    Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
  • An Interview with Dr Günter Jagschies, of GE BioProcess teams
    An Interview with Dr Günter Jagschies, of GE BioProcess teams Interview with Dr. Günter Jagschies, business advisor for the GE BioProcess teams Recorded: Jun 18 2018 65 mins
    AN INTERVIEW WITH DR GÜNTER JAGSCHIES, OF GE BIOPROCESS TEAMS ON WHAT ARE THE MAIN OPPORTUNITIES AND CHALLENGES IN THE RAPIDLY EVOLVING ASIAN BIOPHARMA MARKETS?

    Demand for better, more precise, and effective medicines is driven by a changing global population and increased economic power in growth economies. Asia and the Sub-Saharan Africa are almost exclusively driving the global population growth. Also, the ageing populations are growing there, resulting in an increased demand on the healthcare systems. But simultaneously, there are also more and more Asian patients who can afford treatment with biologics, which is aided by generally lower price levels and improved economic situations in the region.

    Currently, the Asian biopharma industry is mainly concentrated in China, India, South Korea, Japan, and Taiwan, but the development of these markets is going to be heterogenous as they have, for example, different starting points, local policies and biopharma know-how. However, these countries are likely to face a market fragmentation challenge, because a large number of Asian companies are all focusing on the development of biosimilars for only a very few (5-10) original drugs, while at the same time many multinational companies are also entering the region. This requires more product development and manufacturing innovation from the local players to develop a differentiated position in their markets and to move to original drugs, although access to affordable biosimilars is also critical.
  • Manufacturing strategies for Biosimilar: A case of continuous capture
    Manufacturing strategies for Biosimilar: A case of continuous capture Solomon Alva, Biocon & Presented by Yvan Ruland, PhD, Technology Director, Asia/Pacific operations, Novasep Asia Recorded: Jun 15 2018 74 mins
    Presented By Solon Alva Antibody Purification Group Lead, Senior Scientific Manager, Biocon Research Limited
    Continuous manufacturing is an emerging technology in biopharmaceutical industry. The focus of this webinar is a case-study on the benefits of continuous Protein A capture on productivity, capacity utilization and buffer consumption. The potential challenges of adopting the technology such as its integration with cell culture and low pH incubation step has been discussed. There is promise of this technology as an effective platform, and potential of additional savings when considering new generation Protein A resins and in-line concentration technologies.
    Followed by Yvan Ruland, PhD, Technology Director, Asia/Pacific operations, Novasep Asia
  • Fully continuous biosimilar manufacturing framework: A case study
    Fully continuous biosimilar manufacturing framework: A case study Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare Recorded: Jun 14 2018 68 mins
    Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

    The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
    Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
    Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
    As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
    Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
  • Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test
    Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux Recorded: Jun 11 2018 61 mins
    Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test
    Presenter: Karen Zink McCullough, MMI Associates
    The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge
    on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training,
    Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the
    July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and
    more. This Webinar will provide an overview of the contents of this new informational chapter.

    Title: Regulatory Compliance of Alternative Methods
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste
    (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in
    2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device
    Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will
    provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP
    chapters < 1225 > and < 85 >.
  • FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS
    FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora of Pall Biotech | Recorded: Jun 6 2018 65 mins
    – GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing. The drug product produced in clinical studies are given to patients.

    – GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products.

    IF WE CAN”T PROVE GMP WHAT HAPPENS?

    -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.

    -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.

    – Implementation of single will be inhibited

    Presented by Dr Trishna Ray-Chaudhuri, Senior QC Scientist in Direct Materials in Global Analytical Sciences & Technology / Global QC, Genentech

    DRiIVING QUALITY & RESPONSIVENESS IN SINGLE-USE TECHNOLOGIES

    Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems.
    Pall has developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies. We will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.

    Presented by Dr Hélène Pora, Vice President Technical Communication & Regulatory Strategy , Pall Biotech
  • Extractable Study Design & Data Evaluation of Polymeric Product Contact Material
    Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Dr. Ping Wang, Principal Scientist, Janssen R&D & Dr Nixdorf, SGS Group Recorded: Jun 5 2018 74 mins
    Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP and Erin Patton, Charles River Recorded: May 30 2018 65 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • Integration of Disposable Components into Traditional Stainless-steel Facilities
    Integration of Disposable Components into Traditional Stainless-steel Facilities Ron Bates, Bristol-Myers Squibb and Miriam Monge, Sartorius Stedim Recorded: May 22 2018 81 mins
    This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.
  • Implementation Strategies and Challenges for SUT at Commercial scale
    Implementation Strategies and Challenges for SUT at Commercial scale Adam Goldstein, Roche/Genentech & Jacob McNeil, Thermo Fisher Scientific Recorded: May 17 2018 73 mins
    For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

    While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

    In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.

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