CDMO

macromolecular research and development and CRO services
-Antibody drug screening (including bispecific antibodies, nano-antibodies, etc.)

-Antibody Engineering (Structural Optimization)

-pharmacodynamic evaluation

- CAR-T, CAR-NK, TCR-T, etc.

Process Development and Pharmaceutical Research (CMC) Services
(1) Gene sequence confirmation

1. Molecular sequence design and optimization (including humanization and Codon Optimization)

2. Screening and optimization of primer sequence

3. Molecular structure screening and optimization

(2) Cell Line Development and Construction

1. Vector construction and modification, construction of common viruses and optimization of packaging process (including AVV, LV, adenovirus, lentivirus and rod virus, etc.)

2. A variety of host cells can be selected, including CHO-K1, CHO-DG44, HEK 293 and other cell lines with full commercial authorization.

3. A perfect transient and stable rotation system provides protein for customers' early research.

4. An efficient and robust screening platform can obtain the best clone (Top Clone) in 2.5 months at the earliest, with an expression level greater than 5g/L.

5. It has the ability to construct and prepare cell banks (MCB & WCB) in accordance with European, American and domestic GMP regulations.

(3) Upstream process

1. The industry-leading cell culture development platform, combined with the self-developed culture medium system, can quickly complete the cell culture process lock of 3L-50L, and maximize the product yield, quality, reliability, scalability and production consistency

2. Process development of various cultivation modes such as Fed-batch and Perfusion

3. Process scale up to 50L

4. Process optimization, process characterization, process verification, etc.

(4) Downstream process

1. Mature antibody purification platform technology, rich experience in multi-type protein purification

2. The laboratory can purify the protein from micrograms to 100 grams.

3. The product types include monoclonal antibody, double antibody, Fc fusion protein, ADC, recombinant protein, etc. Through the development of chromatography process (AC, AEX, CEX, HIC, Multi-Mode, etc.), filtration process (deep filtration, nanofiltration, ultrafiltration, etc.) and other processes (centrifugation, salting out, etc.), a set of stable and sustainable production process can be developed within 2-4 months, and

(5) Preparation Process

1. Development includes DOE optimization tests on preparation buffer, pH, auxiliary materials, amino acids, etc.

2. Screening the formulation of the preparation and studying the compatibility of the packaging materials

3. Quickly and efficiently screen out suitable formulations and evaluate product stability

quality research
-(1) Provide quality analysis required for process development and prescription development.

(2) Protein Characterization

(3) Release test and stability test to support IND/BLA declaration.

(4) Compatibility research (method development/optimization, method confirmation/verification, method transfer)

clinical materials and commercial production (stock solution/preparation)

(1) It has imported brand disposable bioreactors with various specifications of 50L ~ 6000L, which meets the GMP requirements of China NMPA, EU EMA and US FDA, and supports customers' needs for clinical materials and commercial production.

(2) has the world's first disposable 6000L bioreactor, effectively improving efficiency and reducing costs

(3) Preparation filling meets the different needs of penile bottles (freeze-dried & water needles) and pre-filled injections

registration declaration

Bainnoir Bio has established a complete and standard quality management system, has a team with rich experience in product registration at home and abroad, and can provide customers with the most professional advice from the perspective of laws and regulations and practice. Our services cover the entire process from the registration strategy to the completion of the declaration, and ensure that the entire process strictly complies with SOP procedures to accelerate the listing of assistant customer products.

Registration Service Content

(1) Drug declaration service

assist in the registration and declaration of drugs such as IND/CTA declaration, BLA declaration, new drug listing application (NDA/MAA), biosimilar drug listing application (ANDA), etc.

(2) Improve the application materials

, a professional team with rich experience communicates with customers and adopts a project management mode to assist in the preparation of application materials.

(3) Docking with regulatory authorities

assist customers to maintain good communication with supervision and supervision departments until the declaration is completed.

(4) Update and maintain data

assist in updating the application data in time and continue to provide follow-up support and services after the product is approved.