Common Antibody Formulation Development
InquiryAntibody formulation development is a critical step in bringing therapeutic antibodies from research to the clinic. CD Formulation's experienced team offers comprehensive services to design optimized formulations that maintain antibody stability, bioactivity, and minimize aggregation. Utilizing high-throughput screening with biophysical characterization methods like DSC, DLS, and HDX-MS, we systematically evaluate the effects of pH, buffers, ions, sugars, surfactants, and amino acids on antibody properties. This data-driven approach allows selection of ideal excipient composition and solution conditions catered to your antibody.
The Importance of Antibody Formulation
Antibody drugs are less stable than small molecule drugs and they require a defined environment to remain intact and functional throughout the manufacturing and formulation process and long-term storage. Therefore, it is necessary to screen prescriptions based on the characteristics of antibody drugs. In addition, formulation is also an important consideration when evaluating antibody drugs.
Dosage Forms We Specialize in Developing
We have advanced experimental equipment and instruments, as well as rich research and development experience, which can ensure that the research and development process is fast, accurate and efficient.
This is the most common form of antibody drugs, including intravenous drip and subcutaneous injection. The advantage of solution formulation is that it is easy to administer, but in some special cases, it may reduce the stability of the antibody.
This dosage form has better stability and is more suitable for long-term storage and transportation. Lyophilized dosage forms need to be rehydrated before administration, and then administered by intravenous drip or subcutaneous injection.
Developing stable, effective antibody spray formulations requires expertise in colloid science and mucosal delivery methods. Our team specializes in optimizing spray-dried and lyophilized antibody powders for nasal, pulmonary and sublingual delivery using innovative technologies such as ultrasonic spray freeze-drying. Our antibody spray development services enable efficient mucosal delivery and rapid onset of action.
Our Antibody Formulation Development Process
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Customer Demand Analysis
We fully communicate with customers to clarify customer needs and product application directions.
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Formulation Design
According to customer needs, our technical team designs a suitable preparation plan.
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Experimentation and preparation
Conduct experiments and preparation work according to the design plan to ensure product quality.
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Quality Control
Conduct experiments and preparation work according to the design plan to ensure product quality.
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Packaging and Transportation
Products are packaged and transported according to customer requirements to ensure that the products are not affected during transportation.
Highlights of Our Antibody Formulation Development
- Protein stability investigation uses optical technologies such as DLS and SLS for efficient prediction.
- Based on the QbD concept, DoE experimental design is given priority in formulation development.
- Actively communicate with customers when confirming formulation prescriptions, and prioritize the use of customer-oriented sources of excipients.
Preparation and prescription development is an important step in the research and development of antibody drugs. CD Formulation will fully understand the role of each component when selecting prescriptions. At the same time, we will consider the impact of actual production, storage, transportation, clinical use and other factors on product stability, and ultimately select a reasonable preparation prescription for customers. If you are interested in our antibody formulation development services, please feel free to contact us for more information!
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