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H o y n o z a

Biopharma

//Process Development

Your Partner in Biopharma Process Development and Technology Transfer for Biosimilars

Hoynoza Technologies is a leading provider of comprehensive process development and technology transfer services for biosimilars. Our team of experts has extensive experience in developing and manufacturing biosimilars, including therapeutic proteins, monoclonal antibodies (mAbs), and vaccines. We offer a wide range of services to support your biosimilars development, from process design and optimization to analytical method development and validation.

Our Services

Experience the excellence of our Process Development Services that encompass a wide spectrum of capabilities:

Process Development
We design and optimize scalable and robust manufacturing processes for biosimilars. Our team has expertise in a variety of biomanufacturing technologies, including cell culture, fermentation, and purification. We prioritize efficiency, product quality, and regulatory compliance throughout the development lifecycle.
Analytical Method Development
We offer comprehensive analytical method development and validation to ensure accurate and reliable characterization and quality control of your biosimilar products. Our team has expertise in a variety of analytical techniques, including mass spectrometry, chromatography, and spectroscopy.
Comparability Studies
We conduct rigorous comparability studies to demonstrate similarity between your biosimilar and the reference product. These studies are essential for regulatory approval of biosimilars.
Technology Transfer
We seamlessly transition your biosimilar manufacturing process from development to commercialization with our technology transfer services. Our proven strategies facilitate a smooth transfer while maintaining process integrity.
Regulatory Support
Navigating regulatory pathways can be challenging. Our regulatory affairs team provides guidance and documentation assistance to ensure your biosimilar meets global regulatory standards.
Scale-Up and Manufacturing
We assist you in scaling up your biosimilar manufacturing process to meet commercial production demands. Our facilities are equipped with advanced technologies to ensure consistent product quality.
Risk Assessment and Mitigation
Identifying and managing risks is crucial in biosimilar development. Our experts conduct thorough risk assessments and implement strategies to mitigate potential issues.
Collaborative Approach
We believe in open communication and collaboration. Our team works closely with yours to understand your goals and challenges, ensuring that our services align with your vision.

Connect with us

Telephone

+91-7829 5555 08

Time Schedule

Office Time

Mon - Fri: 9:00 - 18:00