Antibody Drug Production Process Development and Scale-Up
Alta Stomatology is a company dedicated to the research and development of antibody drugs for oral diseases. We possess globally leading cell culture development laboratories and pilot workshops. Our team is composed of experts with extensive experience in biopharmaceuticals, chemistry, oral medicine, and related fields. We offer one-stop services for antibody drug production process development and scale-up, such as cell culture process development, antibody purification process development, and production process scaling. If you have any requirements, please feel free to contact us at any time.
Our Services
Antibody Drug Production Process Development
Selection of Suitable Cell Lines
One of the most critical steps in antibody drug production is the selection of suitable cell lines for expression. Our team evaluates a variety of cell lines to identify the most efficient and cost-effective option for each project.
Construction of Expression Vectors
We design and construct expression vectors tailored to the specific needs of each antibody drug production process. Our experienced team ensures that the vectors are optimized for maximum expression and yield.
Cell Culture and Expression
Our state-of-the-art facilities allow us to optimize cell culture conditions for maximum antibody production. We monitor and adjust key parameters to ensure consistent and high-quality expression of the desired antibody.
Antibody Purification
We employ a variety of purification techniques, including affinity chromatography and protein A/G purification, to isolate and purify the target antibody. Our purification processes are designed to maintain the integrity and functionality of the antibody.
Chemical Synthesis Modification
In some cases, chemical modifications may be necessary to enhance the stability, solubility, or targeting ability of the antibody. Our experienced chemists can design and implement chemical synthesis modifications to improve the properties of the antibody drug.
Antibody Drug Production Process Scale-Up
Scaling Production
By increasing reaction volumes and the number of reactors, among other methods, the production scale is gradually escalated from a small laboratory scale to a pilot scale. This involves adjusting equipment, process parameters, and resource ratios to ensure the maintenance and enhancement of antibody yields in large-scale production.
Optimizing Production Conditions
Systematic optimization is applied to the production process post-scaling, encompassing aspects such as cultivation conditions, expression conditions, and purification conditions. Through meticulous adjustment of these parameters, efficiency, controllability, and the consistency of product quality are maintained even after the expansion of production.
Quality Control and Quality Assurance
Establishing a robust quality control and assurance system involves comprehensive monitoring and control of the entire production process. This includes the implementation of various advanced detection techniques to ensure that the physical properties, biological activities, and other aspects of the product align with predetermined quality standards.
Why Choose Alta Stomatology?
Alta Stomatology has a team of highly experienced and exceptionally skilled professionals with comprehensive expertise in areas such as protein expression, cell culture, and antibody purification. This team not only possesses extensive experience in traditional techniques but also continually engages in learning and innovation, consistently staying at the forefront of scientific research.
The production processes for each antibody drug are unique. Therefore, we offer tailored services to our clients based on the specific requirements of each project, ensuring that our customers receive the highest quality antibody drugs and services.
At Alta Stomatology, quality assurance is at the forefront of everything we do. We maintain stringent quality control standards throughout the production process to ensure the safety, efficacy, and purity of the antibody.
For research use only. Not
intended for any clinical use.
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