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Service Overviews

Background: Development and qualification of drug formulation process are required for IND application. The formulation is essential and critical for drug efficacy evaluation. 


Methods: Drug formulation development is performed using efficient design of experiments (DoE), customer-oriented compliant excipients.
1. The protein stability is efficiently predicted by optical techniques such as DLS and SLS. 
2. Based on the QbD concept, the experimental design of DoE is preferentially applied to drug formulation development. 

3. Actively communication with customers is made for formulation qualification, with priority given to the use of customer-oriented sources of excipients. 

4. Excipient COAs are reviewed according to appropriate pharmacopeias to ensure the excipients are compliant. 


Advantages: A Comprehensive drug formulation development platform. 
1. Complete equipment including optical equipment for buffer screening and constant temperature incubators for formulation screening such as low temperature, acceleration, high temperature, light exposure, and shaking incubators. 
2. The platform is well established, with successful development cases, including monoclonal antibodies, bispecific antibodies, and polyclonal antibodies. 
3. The person in charge of the platform has 8 years of experience in biomedical process research and development.
Service Overviews Background: Development and qualification of drug formulation process are required for IND application. The formulation is essential and critical for drug efficacy evaluation. Methods: Drug formulation development is performed using efficient design of experiments (DoE), customer-oriented compliant excipients. 1. The protein stability is efficiently predicted by optical techniques such as DLS and SLS. 2. Based on the QbD concept, the experimental design of DoE is preferentially applied to drug formulation development. 3. Actively communication with customers is made for formulation qualification, with priority given to the use of customer-oriented sources of excipients. 4. Excipient COAs are reviewed according to appropriate pharmacopeias to ensure the excipients are compliant. Advantages: A Comprehensive drug formulation development platform. 1. Complete equipment including optical equipment for buffer screening and constant temperature incubators for formulation screening such as low temperature, acceleration, high temperature, light exposure, and shaking incubators. 2. The platform is well established, with successful development cases, including monoclonal antibodies, bispecific antibodies, and polyclonal antibodies. 3. The person in charge of the platform has 8 years of experience in biomedical process research and development. Service Contents The staged or overall project services of formulation development and studies on protein stability are available. 1. Early screening studies for protein stability. 2. Pre-assessment of formulations for staged projects. 3. Formulation screening for staged projects. 4. Formulation process development and qualification for overall projects. Service Highlights 1. Comprehensive Study of Quality A comprehensive and multi-dimensional study includes appearance, pH, SEC, CE-SDS, CEX, insoluble particles, Tm value, and activity. The latest regulations in Chinese Pharmacopoeia (2020 Edition), ICH guidelines, USP, etc., are applied to manage the risks during application. A comprehensive characterization is conducted for particle size, PDI dispersion coefficient, sub- visible particles, etc., to ensure the effectiveness and safety of post-marketing formulations. 2. State-of-the-Art Instruments and Equipment International mainstream first-line equipment, such as constant temperature incubators, light incubators, low-temperature shakers, and freezers, is used for protein stability study, which can be put into use only qualified after relevant validations. The equipment has been subjected to relevant regulatory validations and performance qualifications to ensure that the data can support the application. The equipment is regularly maintained and calibrated to ensure accurate and reliable data are outputted. 3. Customer-Oriented Raw materials in compliance and excipients designated or suggested by customers are used for drug formulation. Customized study protocol is provided to customers. A mature modular platform, advanced testing instruments and equipment, and simultaneous. investigation of multiple test indicators boost the early application of projects. Case Stastics 1. Screening of Basic Buffer Solutions and pH Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. This case is to screen the basic buffer in the preparation process. Objectives: To screen suitable the basal buffer for the target antibody protein with a reasonable pH range and protein physicochemical stability. Methods: In the T0 stage, DLS optical technology were be used for characterization, Tonset, Tm, Tagg, and PDI parameters of the target protein in different buffers were analyzed, and appropriate buffers and pH conditions were quickly screened out. Then, 2-week acceleration and high temperature stability studies were carried out to confirm the stability, quality. Results: As shown in Figures Fig. 1A and Fig. 1B, pH and buffer types with relatively high Tonset, Tm, and Tagg values, and relatively low variation in PDI coefficient and quality parameters were obtained. Conclusions: The basal buffer and pH conditions were successfully studied. Fig. 1A Variation trend of characterization results for buffer system screening samples Fig. 1B Variation trend of reduced and non-reduced CE-SDS assay results 2. Screening of Drug Formulation Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. In this case, the formulation screening and optimization of the drug product process were performed. Objectives: To screen and optimize the suitable formulation for the target bispecific antibody protein. Methods: Screening of protein stability, surfactant, and other excipients such as various amino acids, polyols, non-reducing sugars as well as Ps80, Ps20, and P188 was conducted and the stability of target proteins was studied under the conditions stated in Table 1. Table 1 Storage conditions for formulation screening samples Note: X = appearance, pH, protein content, SEC-HPLC, CE-SDS, and CEX-HPLC; Y = osmolarity; Z = binding activity and insoluble particles Results: As shown in Figure B1, the critical quality indicators of target protein in formulations were compared, and the composition of the target formulation was determined to be: 10 mM acetate-histidine (pH 5.0), 8% sucrose, and 0.02% polysorbate 80 (II), with a protein concentration of 20 mg/mL. Conclusions: The formulation screening and process optimization were successfully developed. Fig. 2 Main peak degradation trend of various critical formulation indicators 3. Qualification of Drug Formulation Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. In this case, the formulation qualification of the drug product process was performed. Objectives: To confirm the feasibility of the formulation obtained through optimization and screening. Method: According to customer and application requirements, compliant raw materials were selected for formulation qualification, including COA, supplier, cat. no., and other information. Qualification was performed for the composition, preparation method, solution density, and osmolality of formulation and placebo. The conditions of protein stability study are shown in Table 2. Results: The components in the formulation were sure , the compliance was confirmed, and the variation in the target antibody protein quality parameters satisfied appropriate requirements. Conclusions: The formulation qualification process was successfully developed. Table 2 Formulation qualification study conditions The formulation qualification results showed that the stability of each critical quality and attribute of the target protein satisfied appropriate requirements, and the formulation was successfully developed. The qualification of primary packaging materials and the corresponding protein stability studies will be carried out as scheduled.

Service Contents
The staged or overall project services of formulation development and studies on protein stability are available.
1. Early screening studies for protein stability.
2. Pre-assessment of formulations for staged projects.
3. Formulation screening for staged projects.
4. Formulation process development and qualification for overall projects.

Service Highlights
  • 1. Comprehensive Study of Quality
    1. A comprehensive and multi-dimensional study includes appearance, pH, SEC, CE-SDS, CEX, insoluble particles, Tm value, and activity.
    2. The latest regulations in Chinese Pharmacopoeia (2020 Edition), ICH guidelines, USP, etc., are applied to manage the risks during application.
    3. A comprehensive characterization is conducted for particle size, PDI dispersion coefficient, sub- visible particles, etc., to ensure the effectiveness and safety of post-marketing formulations.
  • 2. State-of-the-Art Instruments and Equipment
    1. International mainstream first-line equipment, such as constant temperature incubators, light incubators, low-temperature shakers, and freezers, is used for protein stability study, which can be put into use only qualified after relevant validations.
    2. The equipment has been subjected to relevant regulatory validations and performance qualifications to ensure that the data can support the application.
    3. The equipment is regularly maintained and calibrated to ensure accurate and reliable data are outputted.
  • 3. Customer-Oriented
    1. Raw materials in compliance and excipients designated or suggested by customers are used for drug formulation.
    2. Customized study protocol is provided to customers.
    3. A mature modular platform, advanced testing instruments and equipment, and simultaneous. investigation of multiple test indicators boost the early application of projects.

Case Studies
1. Screening of Basic Buffer Solutions and pH

Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. This case is to screen the basic buffer in the preparation process.

Objectives: To screen suitable the basal buffer for the target antibody protein with a reasonable pH range and protein physicochemical stability.
Methods: In the T0 stage, DLS optical technology were be used for characterization, Tonset, Tm, Tagg, and PDI parameters of the target protein in different buffers were analyzed, and appropriate buffers and pH conditions were quickly screened out. Then, 2-week acceleration and high temperature stability studies were carried out to confirm the stability, quality.

Results: As shown in Figures Fig. 1A and Fig. 1B, pH and buffer types with relatively high Tonset, Tm, and Tagg values, and relatively low variation in PDI coefficient and quality parameters were obtained. 

Conclusions: The basal buffer and pH conditions were successfully studied.


Fig. 1A Variation trend of characterization results for buffer system screening samples


Fig. 1B Variation trend of reduced and non-reduced CE-SDS assay results

2. Screening of Drug Formulation
Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. In this case, the formulation screening and optimization of the drug product process were performed.
Objectives: To screen and optimize the suitable formulation for the target bispecific antibody protein.

Methods: Screening of protein stability, surfactant, and other excipients such as various amino acids, polyols, non-reducing sugars as well as Ps80, Ps20, and P188 was conducted and the stability of target proteins was studied under the conditions stated in Table 1.


Table 1 Storage conditions for formulation screening samples


Note: X = appearance, pH, protein content, SEC-HPLC, CE-SDS, and CEX-HPLC; Y = osmolarity; Z = binding activity and insoluble particles

Results: As shown in Figure B1, the critical quality indicators of target protein in formulations were compared, and the composition of the target formulation was determined to be: 10 mM acetate-histidine (pH 5.0), 8% sucrose, and 0.02% polysorbate 80 (II), with a protein concentration of 20 mg/mL.

Conclusions: The formulation screening and process optimization were successfully developed.


Fig. 2 Main peak degradation trend of various critical formulation indicators

3. Qualification of Drug Formulation

Background: CMC manufacturing process development was required for a bispecific antibody in IND for the treatment of pancreatic cancer. In this case, the formulation qualification of the drug product process was performed.

Objectives: To confirm the feasibility of the formulation obtained through optimization and screening.
Method: According to customer and application requirements, compliant raw materials were selected for formulation qualification, including COA, supplier, cat. no., and other information. Qualification was performed for the composition, preparation method, solution density, and osmolality of formulation and placebo. The conditions of protein stability study are shown in Table 2.
Results: The components in the formulation were sure , the compliance was confirmed, and the variation in the target antibody protein quality parameters satisfied appropriate requirements. 
Conclusions: The formulation qualification process was successfully developed.


Table 2 Formulation qualification study conditions


The formulation qualification results showed that the stability of each critical quality and attribute of the target protein satisfied appropriate requirements, and the formulation was successfully developed. The qualification of primary packaging materials and the corresponding protein stability studies will be carried out as scheduled.