Proteins & Peptides Batch-release Testing

Batch release testing is one of the most important testing procedures to ensure that drug substances and finished drug products meet established specifications before they are marketed. To minimize the time between production and release, CD Formulation provides validated batch release testing in strict accordance with cGMP regulations to address your protein and peptide physicochemical properties, potency, impurities, identity, purity, and biosafety issues.

What is Batch Release Testing?

Batch release testing is a quality control process that involves testing specific batches or lots of drug substances or finished products to ensure they meet regulatory requirements before being released for distribution or sale. Batch release testing is typically performed to perform analytical assessments of product quality for protein/peptide biopharmaceuticals based on validated compendial (e.g., USP) testing strategies to address product purity, concentration, consistency, identity, and safety.

Explore Our Proteins & Peptides Batch Release Testing Services

As an important part of our quality control testing program, protein/peptide batch or lot release testing services are important to ensure the quality control of proteins, monoclonal antibodies (mAbs), or biosimilars.

Fig. 1 Typical GMP batch release testing programs for protein/peptide drug products. (CD Formulation).

With extensive experience and strong expertise in performing biopharmaceutical batch release testing, our team of biopharmaceutical experts regularly develops and validates methods for technology transfer for various analytical methods required for batch release testing.

Our release testing services are applicable to protein therapeutics, peptide therapeutics, protein/peptide biosimilars, monoclonal antibodies, antibody conjugates, and other biologics. We have extensive expertise in all stages of biological product development, from protein chemistry, molecular biology, and cell biology to quality control experience, supporting the entire product development life cycle from early discovery to IND, BLA, etc.

Typical GMP batch release testing programs include:

Our Expertise

Over the past decades, our scientists have accumulated a wealth of valuable experience and successfully generated data for thousands of batches of various protein and peptide products. Our batch release testing expertise includes chemical, physical, and biological testing as well as pharmacopoeial monograph-based testing to support all types of protein/peptide batch release testing listed below.

• Therapeutic proteins (monoclonal antibodies, biosimilars, fusion proteins, and recombinant proteins).
• Synthetic peptides.
• Therapeutic enzymes.
• Conjugates.
• Vaccines.
• Protein/peptide biosimilars.

Available Standards

• EP
• BP
• JP
• USP
• ISO
• ICH

Why Choose Us for Proteins & Peptides Batch Release Testing?

• We have extensive experience in batch release for multiple modality protein types, such as monoclonal antibodies, recombinant proteins, and drug-antibody conjugates (ADC).
• Our analytical laboratories have the flexibility and broad instrumentation capabilities to meet the needs of changing production plans and timelines.
• Our broad capabilities enable us to perform all batch-release testing for any of the most complex protein/peptide molecules.
• Our global capabilities enable us to support your EU batch release requirements.
• We have successfully performed full-spec batch release testing and generated critical data for hundreds of protein and peptide molecules.
• We adhere to strict quality standards and regulatory guidelines to ensure that all testing is conducted in accordance with industry best practices.
• We offer flexible testing options to meet your single or integrated analytical needs.

Publication

CD Formulation is ready to provide you with batch-release testing services to move your development and manufacturing programs forward. These services adhere to analytical principles of identity, purity, quantity, and product and process-related safety and efficacy. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you to promote development and innovation in the biopharmaceutical field.

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.