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Biopharma

Biopharma

For different products in the biopharmaceutical industry (e.g. monoclonal antibody, bispecific antibody, polyclonal antibody, ADC, fusion protein) and different culture modes (e.g. batch, fed-batch, perfusion, high-density N-1 culture, etc.), ExCell Bio has developed Optivitro series CHO Cell CD medium by using its huge formulation library . This medium can support the high-density culture of CHO cells and the efficient production of therapeutic proteins, and the expression and quality of the protein products are comparable to global brands. Besides,ExCell Bio provides cell culture technical services, including medium formulation development and process optimization, to meet different quality requirements. The media of ExCell Bio have a large number of successful application cases for mainstream production cell lines such as CHO-K1, CHO-ZN, CHO-S, CHO DG44, HORIZON, etc.

Biological drug discovery and development

The process of biological drug discovery and development involves identifying and optimizing potential therapeutic targets. This includes the use of advanced techniques such as synthetic biology to validate targets, develop assays, and optimize lead compounds . The goal is to identify a biological target (e.g., a receptor, enzyme, protein, gene) that plays a role in a disease and develop a molecule that can modulate this target effectively.

Cell line development

Cell line development is a critical step in the production of therapeutic biomolecules. It involves the engineering of a cell line, often mammalian, to produce a therapeutic protein or antibody. The process includes gene cloning, initial clone selection, and optimization of culture conditions to ensure high productivity and stability . The development of a robust, high-yielding, and stable cell line is essential for commercial-scale production.

Medium optimization and large-scale production

Medium optimization is crucial for maximizing the yield of therapeutic proteins. Techniques range from traditional one-factor-at-a-time methods to modern statistical and mathematical approaches that can design optimal fermentation media conditions with fewer experiments . Large-scale production involves scaling up the cell culture process to produce sufficient quantities of the therapeutic protein for clinical use. This requires careful control of parameters such as pH, temperature, and agitation speed to ensure consistent product quality.

Quality control and analysis

Quality control and analysis are essential to ensure the consistency and quality of biopharmaceutical products. A combination of analytical tests is used to monitor batch-to-batch consistency and product quality. These tests include assessments of purity, potency, and biological activity, as well as the monitoring of critical quality attributes (CQAs) such as glycosylation patterns, which can affect the product's half-life, immunogenicity, and pharmacokinetics . Rigorous quality control ensures that the final product meets regulatory standards and is safe and effective for patients.