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Process Development
Process Development
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A thorough understanding of commercially viable manufacturing process is crucial to the successful submission of IND application for gene and cell therapy product. Adhering to the goal of “Developing robust and commercially viable manufacturing process”, we implement our core technologies to support various gene and cell therapy programs with diversified and flexible technology approaches, fully meeting the demands of clients at different stages.  
 
With the technical synergy of high throughput process development (HTPD) and design of experiments (DoE) approaches, we adopt the concept of Quality by Design (QbD) throughout the whole product life cycle, and facilitate a robust and reliable manufacturing process through identifying the critical process parameters. By our higher-than-standard requirements on internal quality control, we have established a comprehensive and rigorous testing and control system in line with regulatory requirements of multiple countries for different categories of gene and cell therapy products, providing a solid foundation for our clients to meet the application requirements. 


Upstream Process

Our versatile upstream process platform covers adherent and suspension cell culture technologies, large-scale transient transfection, and serum-free cell culture, fulfilling your differentiated upstream process development demands for gene and cell therapy products.





Adherent cell culture: cell factories, microcarriers, fixed bed bioreactor, and roller bottles


Serum-free suspension cell culture technologies with improved yield for adenovirus, adeno-associated virus, and lentivirus products


Transient transfection at large-scale: 200 L suspension culture and 600㎡ fixed bed culture


Cell line development: 293 producer cell line (293A, 293T, and HEK293), Vero, Hela, CHO, A549, and Sf9


High-yield cell line domestication based on HEK293, with a 30% yield improvement than commercial HEK293. Further cell line development is still in process

Downstream Process

At OBiO, our downstream process platform includes chromatography and ultrafiltration technologies. We have established a downstream process platform for a convenient large-scale purification and process scale-up with a wide spectrum of technologies including ion-exchange chromatography, hydrophobic interaction chromatography, affinity chromatography, molecular exclusion chromatography and crossflow ultrafiltration. With the integrated downstream process platform, we offer a high throughput, high yield purification process with high quality standard for your gene and cell therapy product. 





Harvest Process: cell lysis, clarification, and filtration


Column Chromatography: affinity chromatography, gel filtration chromatography, ion-exchange chromatography, mixed-mode chromatography


Tangential Flow Filtration: flat sheet membrane cassette, hollow fibers


Linear Scale-up of Purification Process


Product Formulation Development

Analytical Development

OBiO has established a comprehensive quality management system with analytical and testing technologies in compliance with NMPA, FDA, and EMA regulations and guidelines, supporting the development of various gene and cell therapy products with appropriate analytical methods.


Based on the quality management system of cGMP manufacturing platform, and the physicochemical properties of different gene and cell therapy products, we have developed over 230 unique analytical methods, providing tailoring quality control for different products, and maximized guarantee for a successful project implementation. We have built a robust inspection system in accordance with the requirements of international regulatory agencies and implemented end-to-end process control and product release management.


We follow a higher-than-industry internal standard in multiple assays. Namely, we have developed assays for trypsin residue (TryplE detection) and PEI residue to further improve the safety of gene and cell therapy product in clinical applications. In October 2019, we were invited to participate in the project for the verification of standard plasmid for lentivirus detection organized by WHO and National Institute for Biological Standards and Control of UK on behalf of Chinese enterprises.


1
Analysis Experimenting
  • Quality-by-Design concept driven
  • Preparation of analytical method development planning according to project requirements
  • Implementation of analytical method optimization experiment
2
Establish Analytical Method Scheme
  • Conduct research and survey on technical materials in combination of regulatory requirements, references, and the latest industry technology development.
  • Internal review of analytical method scheme
  • External review of analytical method scheme
3
Critical Quality Parameter Confirmation
  • Evaluation of critical quality parameters based on the results from analytical method development
4
Analytical Method Validation
  • Method pre-validation, evaluation of method suitability, accuracy, precision, limit of quantification, and limit of detection
  • Validation of analytical method, and evaluation of specificity, precision, accuracy, linearity range, limit of quantification, limit of detection, and durability
5
Development of Standard Operation Procedure (SOP)
  • Standard operation procedure of testing method
  • Testing standard development
Process Validation


We provide technology transfer, process characterization, and process validation services based on your manufacturing demands at different stages of the product life cycle. Through the collection and evaluation of process data, our engineers will ensure that the overall process flow will provide the products in compliance with quality requirements. Our team are equipped with in-depth insights into the effects and risks of each step of the process, and the influences of critical process parameters on critical quality attributes (CQA), ensuring a consistent performance of an efficient and successful process

Why OBiO?
10+ years of dedication to gene and cell therapy
>130 process development projects & >230 analytical methods developed
Quality-driven team of experts with in-time responding
Efficient technology transfer with optimizing process validation
Process development versatility for various product needs & stages
End-to-end regulatory support with side-by-side navigation
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