Upstream Processing Development Services
We are the industry’s leaders and expert in Upstream Processing (USP) development using our Tide Motion® bioreactors.
We support an integrated approach to service delivery to increase viral expression titer, multiplicity of infection (MOI), and increase cell viability at high-density cultures.
CelCradle X®
Semi-Automated
Harvester
(CCX-SAH)
TideXcell®
Harvesting System
(TXLHS)
- Biomass Expansion
- Autologous/Allogeneic Cell Therapy
- Intracellular Virus
TideXcell™
3,500 up to 5,000 L
Tide 2mm/s: 3,000 - 5,000 L (st. st. tanks)
Tide 6mm/s: 55,000 L
Large st. st. tank,scale for secreted virus production, viral vectors, cellular agriculture (optional edible scaffolds), or biosimilars/biobetters
TideXcell™
300 L
TideXcell™
100 L
TideXcell™
20 L
TideXcell™
2 L
CelCradle X®;
with Semi-automated Harvester Esco standalone bioreactor. Single Bottle, Optional Docking to Isolator.
CelCradle® + CelShaker™
An ESCO standalone bioreactor using single bottle, equipped with semi-automated harvester.
optional docking to Isolator available as per request.
CelXrocker™
A laboratory Tide Motion shaker for process optimization of adherent cell culture.
~Seed from 20,000-60,000 cells/carrier
CHO library suits the expression of recombinant proteins, monoclonal antibodies, and biosimilars implemented with our proprietary bioreactors in a small footprint
Bioprocess optimization using Design-of-Experiments methodology in optimizing cultivations and unit operations
Animal component free media adapted to USP processes and lowering impurities
Robust proprietary technology platform that is scalable up to 5,000 liters capacity
Customizable and reprogrammable fed-batch, continuous, and perfusion mode(s) in hypoxia and/or anaerobic conditions
Downstream Processing Development Services
We integrate a Quality by Design (QbD) approach (based on ICH Q8-11), which is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product.
We offer a development platform in a modular approach, in which the customer can either choose a specific module or request for the entire process development package from bench to scale.
Process Development
- Initial development with screening, selection and combination of downstream processing techniques to achieve the desired quality using a systematic development pathway within acceptable timelines
- Identifying Quality attributes and Criticality assessment
Process Optimization
Optimization of the developed process aiming at:
- Reducing process waste high recoveries
- Establishing optimal conditions for the process variables using statistical tools to design and analyze data (DoE approach)
Process Scale up
Optimization of the developed process aiming at:
- Process platform developed at lab scale will be scaled up to pilot scale
- Demonstration of Process reproducibility and Consistency assessment
Process Characterization and Design Space Establishment
- Comprises risk assessments for the identification of potential Critical Process Parameters (pCPPs), statistically designed experimental studies (DoE) as well as studies assessing the linkage of the unit operations
- Outcome of the studies is the classification of process parameters according to their criticality i.e. Critical Process Parameters and Non-Critical Process Parameters and the definition of appropriate acceptable ranges of operation
- The process and product knowledge gained in these studies can lead to the approval of a Design Space
- Additionally, the information gained in these studies are used to define the ‘impact’ which the manufacturing process can have on the variability of the CQAs, which is used to define the testing and monitoring strategy.
Downstream Process Train Design
On completion of the development activity, our bioengineers will propose the most feasible downstream processing systems tailored for your project requirement.
Note:
- DSP development is not limiting to single-use concentrators or chromatography or microfluidics-size exclusion methods.
- We advise clients to seek our advice and value-added services in conjunction to USP development.
