Large Molecule R&D and CRO Services
- Antibody drug discovery and screening
- Antibody engineering
- Protein therapeutic drugability analysis
- Pharmacodynamic evaluation and efficacy study
Quality Research
- Analyses of quality requirements for process development and formulation development.
- Protein process characterization.
- Release and stability testing to support IND and BLA applications.
- Compatibility studies (method development and optimization, method qualification and validation, and method transfer).
Clinical Materials and Commercial Production (Stock Solution Preparation)
- Multiple 50L – 6000L disposable bioreactors from leading global vendors with various specifications and matching downstream production lines that meet GMP requirements of FDA, EMEA and NMPA and support the needs of customers for clinical materials and commercial manufacturing.
- World's first single use 6000L bioreactor, which effectively improves efficiency and reduces cost.
- Filling of therapeutic formulations to meet various needs of vials (lyophilized & aqueous injection) and prefilled syringes.
Registration Application
BioInno has established a comprehensive quality management system, with a team having extensive experience in product registration in major international countries. We can provide customers with the most professional suggestions from the perspective of laws, regulations and practice. Our services cover the entire process from planning registration strategy through completion and filing of applications to ensure the entire activity strictly complies with requirements and to help customers accelerate product launch.
Drug Application Services
Assist in handling IND and CTA applications, BLA applications, new drug marketing application (NDA and MAA), biosimilar drug marketing applications (ANDA) and other drug registrations and applications.
Improve and Complete the Application Materials
A professional team with extensive experience shall communicate with customers and adopt the best project management mode to assist the preparation of application materials for the entire process.
Communicating with Regulatory Authorities
Assist customers to maintain good communication with supervising and regulatory departments until the application is completed.
Update and maintenance of data
Assist in timely updates of application materials and continuously provide follow-up support and services after the product is approved.
Process Development and Biopharmaceutical Research (CMC) Services
Gene Sequence Confirmation
- Molecular sequence design and optimization (including humanization and codon optimization)
- Screening and optimization of primer sequences
Molecular Structure Screening and Optimization
Development and Construction of Cell Lines
- Vector construction, transformation, and packaging process optimization of common viruses (including AAV, adenovirus, lentivirus and baculovirus).
- A variety of host cells can be selected, including CHO-K1, CHO-DG44, HEK 293 and other cell lines with full commercial authorization.
- Well-developed transient and stable transformation systems provide protein for customers' early research.
- Efficient and robust screening platform within 2.5 months can produce top clones with expression above 5g / L.
- Construction and preparation of cell banks (MCB & WCB) in accordance with European, US and China GMP regulations.
Upstream Process
- Industry-leading cell culture development platform, combined with independently developed cell culture media manufacturing system, can quickly complete the optimization of 3～50L cell culture process, and maximize the yield, quality, reliability, scalability and production consistency of products.
- Process development of multiple cell culture processes such as fed-batch and perfusion.
- Process scale-up to 50L in development.
- Process optimization, process characterization and process verification in later clinical stages.
Downstream Process
- Mature antibody purification platform processes and extensive experience in multi- type protein purification.
- Laboratory scale protein purification from micrograms to 100g.
- Product types include monoclonal antibodies, bispecific antibodies, Fc fusion proteins, ADCs, recombinant proteins, and others, with development of chromatography processes (AC, AEX, CEX, HIC, multi-mode, etc.), filtration processes (depth filtration, nanofiltration, ultrafiltration, etc.) and other processes (centrifugation, salting out, etc.). A set of stable and sustainable production processes can be developed in 2 – 4 months, with an overall yield reaching 70% or higher.
Formulation and F&F Process Development
- Development with DOE optimization testing on formulation buffers, pH, excipients, amino acids, etc.
- Screening of formulations and studying compatibility of packaging materials.
- Quickly and efficiently selecting the appropriate formulation and evaluating the stability of the products.
Multiple 50L - 6000L disposable bioreactors from leading global vendors with various specifications and matching downstream production lines that meet GMP requirements of FDA, EMEA and NMPA and support the needs of customers for clinical materials and commercial manufacturing.
World's first single use 6000L bioreactor, which effectively improves efficiency and reduces cost.
Filling of therapeutic formulations to meet various needs of vials (lyophilized & aqueous injection) and prefilled syringes.
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Molecular sequence design and optimization (including humanization and codon optimization)
Screening and optimization of primer sequences
Molecular Structure Screening and Optimization
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-
-
Development and Construction of Cell Lines
Vector construction, transformation, and packaging process optimization of common viruses (including AAV, adenovirus, lentivirus and baculovirus).
A variety of host cells can be selected, including CHO-K1, CHO-DG44, HEK 293 and other cell lines with full commercial authorization.
Well-developed transient and stable transformation systems provide protein for customers' early research.
Efficient and robust screening platform within 2.5 months can produce top clones with expression above 5g / L.
Construction and preparation of cell banks (MCB & WCB) in accordance with European, US and China GMP regulations.
-
-
-
-
-
Upstream Process
Industry-leading cell culture development platform, combined with independently developed cell culture media manufacturing system, can quickly complete the optimization of 3 - 50L cell culture process, and maximize the yield, quality, reliability, scalability and production consistency of products.
Process development of multiple cell culture processes such as fed-batch and perfusion.
Process scale-up to 50L in development.
Process optimization, process characterization and process verification in later clinical stages.
-
-
-
-
Downstream Process
Mature antibody purification platform processes and extensive experience in multi- type protein purification.
Laboratory scale protein purification from micrograms to 100g.
Product types include monoclonal antibodies, bispecific antibodies, Fc fusion proteins, ADCs, recombinant proteins, and others, with development of chromatography processes (AC, AEX, CEX, HIC, multi-mode, etc.), filtration processes (depth filtration, nanofiltration, ultrafiltration, etc.) and other processes (centrifugation, salting out, etc.). A set of stable and sustainable production processes can be developed in 2 - 4 months, with an overall yield reaching 70% or higher.
-
-
-
Formulation and F&F Process Development
Development with DOE optimization testing on formulation buffers, pH, excipients, amino acids, etc.
Screening of formulations and studying compatibility of packaging materials.
Quick and efficient selection of appropriate formulation and evaluation of product stability.
-
-
-
Analyses of quality requirements for process development and formulation development.
Protein process characterization.
Release and stability testing to support IND and BLA applications.
Compatibility studies (method development and optimization, method qualification and validation, and method transfer).
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