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The Highest Quality of Cryopreservation Media

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About CaseBioscience

With a strong commitment to quality, we are an ISO 13485:2016 Certified Manufacturer specializing in sterile media products for critical preclinical research and medical applications.

Our meticulous attention to detail and operational excellence ensure the production and delivery of high-quality products with batch-to-batch consistency and rigorous quality controls from raw materials to final product release.

Our mission is to serve as a reliable, flexible, and punctual strategic partner, providing support for crucial research, preclinical, and clinical activities. We offer manufacturing services, scientific assistance in media formulation, and optimization of existing formulations to meet your specific needs.

Our dedication to scientific advancement drives us to develop innovative media formulations for cell cryopreservation, cell culture and cell handling in cell therapy, regenerative medicine, and other sensitive medical applications.

cGMP MEDIA MANUFACTURER

RESEARCH & DEVELOPMENT PARTNER

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ISO 13485:2016 CERTIFIED

FLEXIBLE PROTOTYPING

Expertise in Sterile Media Manufacturing

Our team has many years of experience and in-depth knowledge of formulating and manufacturing culture mediums and ancillary products as Class III & II medical devices in the human Assisted Reproduction (ART) area under the strictest of global regulatory guidelines ISO6485, MHRA, EMA, FDA.

Our experience and expertise in high-quality manufacturing have resulted in a track record of success and have demonstrated our team’s ability to repeatedly execute complex manufacturing and logistics of personalized and highly regulated biologics products with high batch-to-batch consistency and performance. Our goal is to leverage our leading expertise from the highly regulated field of human ART culture media development & manufacturing into the cell & gene therapy, regenerative medicine, biobanking and drug discovery markets.

Batch-to-batch high-quality,
consistent solutions

CaseBioscience Team has a proven track record of manufacturing high-quality, consistent culture media and cryopreservation solutions. Our expertise includes custom manufacturing tailored to meet the highest regulatory standards worldwide, ensuring that our products support your research and clinical success.

We rigorously adhere to Current Good Manufacturing Practice (cGMP) guidelines enforced by the US Food and Drug Administration (FDA). cGMP is a comprehensive system designed to ensure the proper design, monitoring, and control of our manufacturing processes and facilities. By following these stringent regulations, we guarantee that every product we produce meets the highest standards of quality and consistency. We understand that the success of your research and clinical applications relies heavily on the quality of cell culture, bio-preservation, and storage media products and protocols.

Our dedicated team has a long-standing history of delivering pharmaceutical-grade products and services. We maintain our unwavering commitment to quality through:

  • Dedication to Regulatory Excellence: Upholding the highest regulatory standards at every step of the cGMP manufacturing process.
  • Stringent Quality Control: Implementing rigorous quality control measures across all aspects of manufacturing to ensure consistency and reliability.
  • Optimized Formulations: Utilizing pharmaceutical-grade ingredients to develop optimized formulations that meet the specific needs of our clients.

Reliable, Trusted & Flexible Manufacturer

At CaseBioscience, we pride ourselves on being a reliable, trusted, and flexible manufacturer in the biotech industry. We understand the critical nature of your research and applications, ensuring our products consistently meet the highest standards through top-quality materials and rigorous quality control measures. Our commitment to transparency and accountability builds trust, as we maintain open communication and provide detailed information about our manufacturing processes and product specifications. Flexibility is at the core of our approach, allowing us to tailor our solutions to meet your unique project requirements. Supported by a team of experts and a dedication to scientific excellence, CaseBioscience empowers your research and drives your success.

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