Proteins & Peptides Sterile Formulation Development

Protein/peptide sterile preparations are usually a type of drug used for injection or ocular administration, including injection suspensions, injection solutions, eye drops, etc. This type of drug usually uses a precise production process to strictly control microbial contamination during the preparation process to ensure the sterility of the product. As a comprehensive solution provider for protein/peptide formulation, CD Formulation provides a series of protein/peptide sterile formulation development and manufacturing services, including formulation development, production process design, aseptic filtration, sterilization, and other links, ensuring the final product meets regulatory requirements.

What Are Sterile Formulations?

Sterile preparations refer to drugs that have strict aseptic control measures during the production and packaging process to ensure that there is no microbial contamination in the preparations. These drugs are usually in the form of injections, eye drops, infusions, oral liquids, etc., which require operation in a sterile room and use high temperature, high pressure, and other methods to kill microorganisms. The quality requirements of sterile preparations are very high, because microbial contamination may cause serious health hazards to the human body.

Explore Our Proteins & Peptides Sterile Formulation Development Services

CD Formulation provides comprehensive services for protein/peptide sterile formulation development, from the simplest sterile liquid formulations to complex sterile lyophilized formulations and sterile nanoformulations. Our experienced formulation scientists take cGMP requirements into account and can develop robust formulations that meet your needs.

In addition, our formulation department is equipped with state-of-the-art analytical equipment to ensure the best data and the shortest turnaround time, enabling rapid decision-making during the formulation development process.

Our protein formulation experts are able to perform operations including but not limited to:

• Selection and compatibility studies of excipients.
• Sterile formulation development.
• Sterile formulation scale-up.
• Sterile filling and manufacturing.
• Sterility testing.

Our Capabilities for Proteins & Peptides Sterile Formulation

Sterile formulation is our core capability in protein/peptide formulation development. Thanks to advanced sterile equipment and facilities, we strictly adhere to aseptic technical operating procedures to ensure that there is no contamination throughout the production process. Our sterile formulation team is adept at developing a variety of powerful sterile formulations to meet your special needs.

Our sterile formulation capabilities include but are not limited to:

Protein & Peptide Sterile Liquid Formulations (Injectable and Ophthalmic Formulations)

Through a variety of protein/peptide stability strategies, we are able to manage products with unique challenges, including proteins/peptides with solubility issues or stability issues, to provide you with powerful sterile liquid formulations.

Protein & Peptide Sterile Lyophilized Formulations

For preliminary stability studies that indicate that sterile liquid formulations do not meet the expected target product properties determined early in your project, sterile lyophilized formulations will be the first choice. Our experts support your sterile lyophilized powder development to achieve stability and longer shelf life of drug products for clinical or commercial applications.

Protein & Peptide Sterile Nanoformulations

Protein/peptide sterile nanoformulation is our key strategy to stabilize proteins/peptides, improve bioavailability, and achieve targeted delivery. Our scientists encapsulate or surface chemically modify proteins/peptides on nanocarriers to obtain target products.

Protein & Peptide Sterile Generics

Our sterile generic drug development services involve conducting biosimilar studies to evaluate the similarity of generic drugs to original drugs and ensure the quality, safety, and efficacy of generic drugs.

Fig.1 Proteins/peptides sterile formulation. (CD Formulation)

Workflow for Proteins & Peptides Sterile Formulation Development

• Preformulation studies, including studying the thermal and pH stability of proteins/peptides, as well as photostability and oxidation potential.
• Formulation studies, including determining the necessity and appropriate strength of surfactants/stabilizers/fillers.
• Process compatibility studies, evaluating how the desired formulation will perform in a sterile manufacturing environment to better understand how the product will react when in contact with different materials (e.g., glass, stainless steel, and plastic) during the manufacturing process.
• Aseptic filtration and filling, involving the process of passing the protein/peptide through a filter to remove microorganisms and particulate matter, and then filling the sterile product into a container.
• Quality control, including determining the level of physical, chemical, and microbiological contamination of the product to ensure that the product meets the specified quality standards.
• Stability studies, including determining the stability of the product under different conditions, such as temperature, humidity, and light conditions.

Integrated Sterile Filling Capabilities

We understand the unique challenges of traditional or niche indications in protein/peptide sterile drug development. We offer a variety of dosage forms to meet your molecule needs, including:

• Liquid-filled viial filling.
• Lyophilized vials.
• Prefilled syringes.
• Prefilled cartridges.

Why Choose Us for Proteins & Peptides Sterile Formulation Development?

• We have extensive expertise and experience in executing sterile formulation development of proteins/peptides.
• We provide diverse support throughout the entire sterile formulation product lifecycle of proteins/peptides, from early formulation development, analytical development, to clinical testing and manufacturing.
• We have extensive global regulatory and filing experience for sterile formulations of proteins/peptides (EMA, FDA, PMDA).
• We have the capabilities to maintain aseptic fill and close or terminally sterilize injectables.
• We provide flexible and tailored solutions to meet our customers' specific needs and requirements.
• Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

CD Formulation is always at the forefront of protein and peptide formulation development, dedicated to providing unparalleled protein/peptide sterile formulation development services to the pharmaceutical industry. Our formulation scientists combine proven sterilization technology with the latest protein and peptide science knowledge to create formulations that optimize stability, appearance, and manufacturability. Please contact us today to get your exclusive solution if you are interested in our services.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.