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Development of autologous adipose derived mesenchymal stem cell therapy: Lessons learned from treating more than 250 patients
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µRAMOS: Online monitoring of respiration activities in 96-Deepwell Microtiter plates
Online monitoring systems for single-use micro bioreactors are powerful tools for the characterization of microbial cultures in bioprocess development. Among these bioreactor platforms, 96-deepwell microtiter plates are well established for process development and clone screening in high-throughput applications. Yet, a suitable non-invasive online monitoring device for 96-deepwell microtiter plates is still missing. For process characterization and a subsequent transfer to larger scales, one essential online parameter is the respiration activity. It is defined by the oxygen transfer rate (OTR), the carbon dioxide transfer rate (CTR), and the respiration quotient (RQ). The RAMOS technology (Respiration Activity MOnitoring System) is one available system for the measurement of respiration activities, yet it is limited to shake flasks. Hence, this study focuses on a transfer of the RAMOS technology to commercially available single-use 96‑deepwell microtiter plates. The novel µRAMOS system provides insights into the respiration activity of microorganisms cultured in 96-deepwell microtiter plates, and thereby, enhances the throughput in early-stage process development.
A new miniaturized optical sensor system was developed to allow an accurate and sensitive measurement of the gas composition within each individual well of the microtiter plate. Cultivations of microbial model organisms were conducted to show the application potential for process characterization using the µRAMOS technology. To evaluate the measurement accuracy, parallel experiments in shake flasks and 96-deepwell microtiter plates were performed. Results from both scales are in very good agreement.
In conclusion, a non-invasive high-throughput online monitoring device for 96-deepwell microtiter plates was developed, allowing accurate and sensitive measurements of respiration activities. Hence, with the µRAMOS technology monitoring of the respiration activity becomes available in the µL-scale and provides important scale transfer criteria. Thus, the new technology has the potential to accelerate process development for industrial applications
Learning from flexpack industry: Closing the loop
Recycling of used plastic material is one of the key challenges for the plastic industry. The European single use plastic directive (Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment) bans certain single us plastics like straws, food plates, balloon sticks, EPS (expanded polystyrene) food containers as of 3rd July 2021. Also, collection rates for single use plastic bottles are set within this directive. However, the end goal is an EU circular economy model via which remaining disposable plastics will be reusable or recyclable by 2030.
Right now, the SUPs ban exempts medical-related plastics, including test kits, FFP2 or medical masks as well as gloves that have become so widespread during the Covid pandemic. However, this may also change in future.
The most obvious way to recycle plastic and therefore avoiding plastic waste going into incineration or even worse into landfill is the mechanical recycling. Some industries with dedicated and pure material streams - preferably on mono materials - are using this technology already very effectively e.g. transport packaging, PET or HDPE bottles with implemented collection systems.
In Flexpack industry often multilayer laminates are in use due to their superior properties. These materials are often combinations of different Polymers and are therefore generally more complex in recycling. However, first examples show that this recycling loop is feasible even in food packaging applications. Published recycling studies done by Polymer producers show the impact of certain PA or EVOH quantities in recycled materials. First own closed loop projects with dedicated customers support these studies. Further optimization - especially during the compounding process need to be done and first concepts will be presented.
Contaminated materials or very complex structures may be converted via chemical recycling routes. A first proof of concept will be presented. From the production of materials, via the purpose of use, collection, chemical recycling, polymer production and use chemically recycled polymer (Mass balance system) back into film production.
The use of PIR (postindustrial recyclates) or even PCR (post-consumer recyclates) in very demanding markets like medical device or SUT packaging may be limited. However, this kind of packaging waste may be used in technical applications. A chemical recycling loop would be open also for demanding applications, as basically virgin material will be produced and hence deliver plastic material fulfilling highest quality standards
Growth through sustainable business model innovation using ICIS Framework
COVID-19 pandemic is a setback for sustainable development. For the first time since the adoption of the SDGs in 2015, the global average SDG Index score for 2020 has decreased from the previous year: a decline driven to a large extent by increased poverty rates and unemployment following the outbreak of the COVID‑19 pandemic. It becomes more urgent that businesses continue to evolve and innovate to minimize the impact of the pandemic and to safeguard our future for the next generation.
This presentation addresses how a technology and service provider in life science industry can meet sustainability challenges and their biopharma customers with a transformative agenda and create growth through creation of sustainable business innovation, based on the following manifesto:
1) We must innovate our business models; how we design, build, sell, distribute and take responsibility of our products and services throughout the entire lifecycle.
2) We must invent new services and technology that creates positive handprints, supporting a long-term transition
The presentation will report out, using single use technology and supply of pre- made buffer and process liquid, as an example, on how to
1) Adopt and develop what is currently available; technology and products that supports a sustainable road map.
2) Phase out process, products and technologies that are not sustainable, short or long term.
ICIS (Initiate, Commit, Innovate, Synthesis) framework in Figure 1 will be presented to illustrate creation of a new business model for single use technology and pre-made buffer liquid production service using a human centric innovation principle, identifying suitable design and innovation tools, addressing planetary boundaries to limit ecological footprint while driving growth and impact – social, ecological and economical
Sustainable resins for single-use technologies
The healthcare industry is a focus segment for SABIC as a materials supplier. Growing our presence requires a thorough understanding of our customers’ challenges and requirements. In addition to ensuring high quality products and complying with applicable regulations, there is an increasing demand around sustainability. SABIC has developed high quality certified renewable and recycled materials, which respond to the industry’s need for consistency and predictability while assisting in reduced carbon emissions. In this presentation, we will discuss the approach to generate such polyolefins and engineering resins and the implications for the user
Rapid and high yield microbial protein production system for human and animal vaccines: C1 Filamentous fungus Thermothelomyces heterothallica
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Affinity purification of SARS-COV-2 spike protein receptor binding domain produced in a C1 fungal expression system
The Receptor Binding Domain (RBD)of the spike protein of SARS-CoV-2 has shown promise for diagnosis, treatment, and development of vaccines for COVID-19. However, two problems persist with large scale production of RBD: 1) lack of high productivity upstream cell culture, 2) absence of a commercial, highly selective affinity resin. In an effort to overcome these limitations, we evaluated two novel technologies for the production and purification of RBD.
Briefly, RBD was expressed using C1, an engineered fungal strain of Thermothelomyces heterothallica (DyadicInternational1). The C1 platform expresses glycosylated antigens with high productivity, stability, and purity. RBD was purified using a novel affinity resin2 known to produce yields of 90% to 95% purity in one chromatography step. Affinity purification did not affect protein quality, as demonstrated by ACE-2 binding of RBD. The novel affinity resin showed excellent base stability, consistent product quality, and similar ACE-2 binding activity over 40 cycles.
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Increasing of PK15 biomass for PCV viral antigen production using modelbased and media optimization strategies that consider cellular metabolic requirements
Porcine circovirus associated disease (PCVD) is responsible for a significant economic loss in the livestock industry. A vaccine based on a viral antigen has been developed to prevent this disease, and it is produced industrially in the pig’s kidney cell line PK15. However, both biomass and viral antigen production are limited in the current attachment culture bioprocess set-up.
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