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Viral in 2020: Tide Motion Platform for Viral Vector Manufacturing

Jan 17, 2020

Why the TideXcell^™ Cell Harvesting System Is a 20/20

Jan 17, 2020

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Article has been published on BPI Technology Highlights and courtesy from BPI Journal

Esco Aster and Esco VacciXcell: The Difference

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Esco Aster

Esco Aster Pte Ltd is a cGMP CDMO operating as an independent subsidiary of Esco Group of companies. We are providing process development (PD) and contract manufacturing (from upstream to downstream, formulation and filling), consultation, clinical research services bridging the translation gap from bench to bedside.

THE
DIFFERENCE

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Esco VacciXcell

Esco VacciXcell is the bioprocessing tools microsite for the Esco Group of companies. It includes marketing all Esco bioprocessing tools from laboratory into commercial production as well as 3rd party, alliance, and non-Esco tools utilized within our Tide Motion Platform.

Highest Yield.
Lowest Cost.
Linearly Scalable.
Multi-Functional In-Situ Configuration.

WHY USE TIDE MOTION

1^st patented single use bioprocessing method in the far east and 2^nd single use bioprocessing method patented in 2002 after wave method.
Large Surface Area - 5.5g of carrier is already equivalent to 15,600cm² of surface area
Highest Productivity - 5.5g of carrier is able to culture up to 5x10⁹cells^*
Lowest Downstream Processing Cost - cells are fixed within proprietary BioNOCII macrocarriers and are separated from the media. This makes cell harvesting or media harvesting much easier
No Oxygen Limitation - Dual oxygenation action provides cells with ample oxygen regardless of the bioreactor scale.
Extremely Low Shear Stress - Gentle upward and downward tide motion (2mm/s) provides nutrients and oxygen to cells without applying shear stress, perfect for shear sensitive cells. Minimizes impurities with host cell protein and DNA/RNA.
No Bubbling, No Foaming - Tidemotion bioreactors use separate vessels for culturing and stirring thus isolating the cells being cultured from any form of bubbling or foaming.
100% Continuous Processing >3 months - Ideal for biosimilars / biobetters, Monoclonal Anti-bodies (MABs), and recombinant proteins. As cells are immobilized, cell retention devices which are typical for perfusion based suspension Chinese Hamster Ovary (CHO) cells are not required to separate cells from media. This means no fouling, foaming, and scalability issues resulting from flow rate limitations of cell retention devices.
Controlled cell growth (Batch mode) - Controlled cell growth during cell culture to promote productivity in batch mode via extending exposure time during tide motion without requiring additional feed control.
Shortest bioprocess scale up development time - parameters developed in academic /industrial R&D can be easily translated into clinical trials and commercial production as parameters are identical and hence linearly scalable without complex scale up bioprocess calculations (as those found in Stirred tanks).
Immortal cell lines - Freezing cells in G0 and G1 phase by nutrient starvation by deprivation of glucose to boost productivity of protein expression.

*based on vero cell line. Yield can further be increased using our adherent media Plus^TM Vero

WHY CHOOSE TIDEXCELL^™

3D in vivo like Culture Environment - allows cell-to-cell contact and a large surface area to footprint ratio for culturing cells
True Linear Scalability - Same parameters are used from 0.1L packed bed volume lab scale for seed preparation, all the way up to 5,000L packed bed volume production scale, eliminating lengthy developmental processes and parameter optimization common in scaling up in microcarriers and / or suspension culture. Unlike other packed bed or hollow fiber systems, seed cells are not prepared in 2D and expanded in 3D, this is 3D to 3D.
Closed cell harvesting system - TideXcell^™ cell harvesting system is a powerful and automated system for harvesting viable cells from 2L to 20L TideXcell^™ bioreactors with more than 90% recovery
100% nutrient exchange for highest virus titer - Media used for cell growth can be 100% pumped out as waste and 100 % new media is used after virus seeding for virus growth. This has higher yields for VLPs compared to stirred tank which new media can only be perfused in.
Hybrid System - Can be configured for either single use or combination of single use & autoclavable vessels.
Difficult Viruses - Parameters such as temperature, pH and oxygen levels are automatically monitored and adjusted to cater to specific virus requirements. TideXcell^™ also has extremely low shear stress for stress sensitive viruses and is capable of harvesting using an automated harvesting system for non-secreted viruses.
Even seeding - Unlike other packed bed systems, single use TideCell catridges allow even seeding within the packed bed itself via our single use cartridges.
Isolator Capability - CelCradle/ TideXcell^™ can be easily integrated inside an Esco Pharma isolator in case the application requires BSL3/4 environment or for Autologous / Allogeneic cell & gene therapy. Controls can be fully integrated into 1 common HMI with Esco BioVap (Hydrogen peroxide biodecontamination or Ammonia system for 6 log reduction in bioburden and/or Esco Autoclave mounted on the side).
cGMP References - TideXcell^™ is used in current good manufacturing practice (cGMP) Facilities for both commercial human and animal vaccines that are certified to FDA, eucGMP, Japanese Industrial Standard (JIS), Pharmaceutical Inspection Co-operation Scheme (PIC/s) standards.
PAT/IPQC - Process Analytical Techniques (PAT) and In Process Quality Control (IPQC) via patented single use sampling method of BioNoc II allows IPQC for cell counting during production unlike other packed bed bioreactors which need to be dis-assembled during process development.
In Situ Configurable - Batch, Fed-Batch, Perfusion, continuous processing and parameters for low temperature, anaerobic/hypoxic conditions, single use/autoclavable as well as mixing, feed & harvest tanks with auto switch pumps can be easily configured in-situ via Wonderware. These are easily programmed with minimal training without coding background.
SCADA enabled with 21 CFR part 11 compliance and CSV - Esco Healthcare factories globally in Singapore/USA/UK provide Supervisory Control and Data Acquisition (SCADA) or Distributed Control System (DCS) Configuration and deployment with computer system validation (CSV). We are well versed in DeltaV, Pcs7 by default Scada system deployed on VacciXcell adherent single use platform is using Wonderware running on Siemens programmable logic controller (PLC). Siemens human machine interface (HMI) can be provided for standalone non SCADA or non-multi-functional dedicated bioprocessing applications
International support - Esco TideXcell^™ is sold & serviced globally by Esco’s 25 direct sales/service offices, factories and trained sales & service partners.

WHY CHOOSE CELCRADLE^™

Ease of usage - CelCradle was designed to be used with basic science and good aseptic technique, good laboratory practice, like in normal static 2D culture (T Flasks, Roller bottle systems, petri dishes, stacked planar culture) but provide higher cell density. Usage is similar to T-flasks with simple caps and easy parameters while pH is controlled by manually adjusting CO2 concentration inside the CO2 incubator. A wide variety of bottles allows production of various adherent cell lines, viruses and proteins.
LIMS - A simplified laboratory information and management systems (LIMS) allows ease of recording of data for DOE and eventual scaling up into TideCell.
Fully single use perfusion option with closed cell harvesting
Portable and Intuitive - CelCradle^™ can easily fit inside a 6ft³ CO2 incubator for batch culture and 8ft³ CO2 incubator for perfusion culture. It has only two (2) parameters which can easily be optimized. . The magnetic control box of the CelCradle^™ can be magnetized to the outer wall of the CO2 incubator, allowing parameter change without opening the incubator.
Technology Transfer made Easy - CelCradle^™ uses the same principle as roller bottles, easily adapting whatever protocol or parameters are already established. Transferring from static culture like T-flasks or hyperstacks to CelCradle^™ is also just as easy. Learn More
Flexible - Capable of doing Batch, Fed-Batch and Perfusion culture by simply changing accessories.
High Yield in a Small Footprint - One (1) CelCradle^™ bottle containing only 5.5g of macrocarrier has a yield equivalent to Twenty (20) 850cm2 roller bottles or One-hundred Twenty Five (125) 150cm² T-flasks
3D in vivo like Culture Environment - allows cell-to-cell contact and a large surface area to footprint ratio for culturing cells.
True Linear Scalability - CelCradle^™ is a 0.1L packed bed bioreactor that can easily be used for seed preparation for TideCell^® bioreactor that scale all the way up to 5,000L packed bed volume production scale, eliminating lengthy developmental processes and parameter optimization common in scaling up in microcarriers and / or suspension culture. Unlike other packed bed or hollow fiber systems, seed cells are not prepared in 2D and expanded in 3D, this is 3D to 3D
Isolator Capability - CelCradle^™ can be easily integrated inside an Esco Pharma isolator in case the application requires BSL3/4 environment or for Autologous / Allogeneic cell & gene therapy controls can be fully integrated into 1 common HMI with Esco BioVap (Hydrogen peroxide or biodecontamination system for 6 log reduction in bioburden and /or Esco Autoclave mounted on the side, Esco Centrifuges, Co2 Incubators, Peltier Blocks).
International support - Esco CelCradle^™ is sold & serviced globally by Esco’s 25 direct sales/service offices, factories and trained sales & service partners.

WHY CHOOSE VACCIXCELL HYBRID BIOREACTOR^®

VacciXcell Hybrid Bioreactor was Conceptualized and designed in Singapore in 2016.
Four-in-One - VacciXcell Hybrid Bioreactor is capable of performing four (4) types of culture processes namely adherent culture using microcarrier, adherent culture using macrocarrier, suspension culture and fermentation. Adherent culture is performed through patented tidemotion technology while suspension culture and fermentation are performed through standard stirred tank process.
Perfect for Vaccine R&D, Pre-Screening - when deciding between suspension or adherent cell lines or converting adherent cell lines to suspension, data can be easily compared. Comparison can be made by using conventional microcarriers or our packed bed BioNoc II (when using tide motion).
Perfect for Cell & Gene Therapy - Adeno-associated Virus (AAV) / Lentivirus (LV) or other Simian Immunodeficiency Virus (SIV) production, Hek 293T with transient transfection, autologous or allogeneic mesenchymal or exosomes production ( including anaerobic hypoxic mode).
Perfect for Virus Production using adherent cell lines
Process Development for Tide Motion - Linearly scalable across different packed bed volumes
Perfect for new Bioprocessing Labs - Since the system is capable of performing four (4) types of culture, researchers can easily compare how one cell line performs or reacts to one type of culture method as compared to another. Costs are saved by not having to purchase multiple separate bioreactors. This allows researchers to determine which type of culture is the best one to go with when scaling up. Different culture vessels for fermentation 1:3 and autoclave between batches ensures minimal cross contamination. A wide variety of culture vessels which are easily inter-changeable between Tide Mode and Suspension Mode via a top mounting plate allows ease of usage without having to purchase a variety of culture vessels. Smaller vessels for suspension culture at 0.5 liter smallest can be provided
Temperature Control by Water Jacket - allows culturing in low or high temperatures for special cases
- Low Temperature - for viruses which would have better yields in low temperature such as BEFV or applications which require low temperature such as in aquaculture vaccines
- High Temperature – For applications which would require high temperatures such as in developing DNA vaccines.
Easy Scale Up - The adherent process of the hybrid bioreactor can easily scale up to TideCell^™ bioreactors while the hybrid bioreactor is also equipped with mass flow controller for suspension & fermentation process can scale up to larger stirred tanks. ATF systems for perfusion for higher concentration of cells for less complex seed trains running in suspension.
Isolator Capability - VacciXcell^™ Hybrid can be easily integrated inside an Esco Pharma isolators in case the application requires BSL3/4 environment or for Autologous / Allogeneic cell & gene therapy controls can be fully integrated into 1 common HMI with Esco BioVap (Hydrogen peroxide biodecon or Ammonia biodecontamination system for 6 log reduction in bioburden and/or Esco Autoclave mounted on the side).
International support - Esco VacciXcell Hybrid bioreactor is sold & serviced globally by Esco’s 25 direct sales/service offices, factories and trained sales & service partners.

WHY CHOOSE GLUCCELL?

Small Sample Volume and Fast Analysis - The specially designed glucose test strip requires as little as 3uL of sample volume of culture media in order to accurately analyze the glucose concentration. GlucCell^™ meter boast of being able to measure and display the result within just 15 seconds, ensuring minimal process and decision making delay for end users.
Portable Meter and Disposable Test Strips - Small and compact size allows measurements to be done right next to the culturing device (i.e. bioreactors, fermenters). It is also small enough to work comfortably under a biosafety cabinet. The interface of the GlucCell^™ meter is very intuitive, making it easy to use with minimal to no learning curve. The meter can store up to 180 test results with corresponding time and date, making recording of important data convenient and effective
Safe and Secure Handling - Its size and portability allows end user to easily move it under a biosafety cabinet where the testing process can be done. The specially designed glucose test strip are also single use, ensuring that there would be no issues of cross contamination. The GlucCell^™ gives end users much more flexibility on where and how to do their task.
Accurate and Reliable Results - The accuracy is independent with the ingredients and components of either serum-containing or serum-free culture medium. GlucCell^™ Glucose Monitoring System is capable of achieving results greater than 90% accuracy, 95% precision and 0.9997 linearity. Moreover, the result is 99.5% correlated with other expensive biochemical analyzers.

Human Vaccine

Animal Vaccine

Human Vaccine

Genetic (DNA/RNA) Vaccine

Cell / Regenerative Therapy

Autologous Cell Therapy

Allogeneic Cell Therapy

Skin Tissue Mass Production

Exosomes

Biosimilars/ Biobetters

Monoclonal Antibody

Recombinant Protein

Gene Therapy

Diagnostics

Artificial Meat

Cosmeceuticals

Organoids

Bone Regeneration

Viral in 2020: Tide Motion Platform for Viral Vector Manufacturing

Why the TideXcell™ Cell Harvesting System Is a 20/20

World Advanced Therapies Congress and Expo

2020 ISPE Europe Annual Conference

Pharmaconex

World Vaccine Congress Washington

Interphex

International Society for Extracellular Vesicles (ISEV)

International Society for Cell Therapy (ISCT)

2nd Annual Gene and Cell Therapy: Quality Developments to Commercialization Summit

The 18th International Conference of Asia Pacific Association of Surgical Tissue Bank

BioAsia Taiwan International Conference and Exhibition

International Society for Pharmaceutical Engineering (ISPE)

Thailand Lab International 2020

Tissue Engineering and Regenerative Medicine (TERMIS)

BioProcess International Conference and Exhibition

Developing Countries Vaccine Manufacturers Network (DCVMN)

CPhI

World Vaccine Congress Europe

European Society of Gene and Cell Therapy / British Society for Gene and Cell Therapy Collaborative Congress (ESGCT/BSGCT)

International Society for Pharmaceutical Engineering (ISPE) Pharma

Cell Therapy Manufacturing and Gene Therapy Congress