Excell Bio T Cell Serum-Free Culture Medium Helps Customers Successfully Obtain Fda New Drug Clinical Trial (Ind) Approval

We are pleased to announce that OptiVitro T cell serum-free medium has helped customers successfully obtain FDA New Drug Clinical Trial (IND) approved !

IND is an important milestone for new drugs from research and development to market launch, which means that clinical trials of new drugs can officially begin. It is also an important link in the communication and cooperation between new drug research and development companies and regulatory agencies.

In the field of cell and gene therapy, one of the main challenges of IND filing is the quality control of raw materials and excipients. IND filing requires the use of animal-free production materials as much as possible to reduce the risk of introducing exogenous viruses. As one of the key raw materials, OptiVitro T cell serum-free culture medium from OptiVitro is produced and managed in full compliance with GMP standards and has completed the US FDA DMF filing. Customers using OptiVitro T culture medium can directly cite the relevant DMF number 037572 when submitting regulatory filing documents for clinical applications or marketing registrations to the FDA, saving product review and evaluation time, reducing the preparation work for new drug clinical filings, and to a certain extent promoting the drug marketing filing process.

Ecosine's OptiVitro T cell serum-free culture medium can support the preparation of high-quality and high-performance cell therapy products. At the same time, its production process and quality control system have met international standards and regulatory requirements, which can effectively assist in the rapid declaration of new cell therapy drugs and support the successful "going global" of domestic innovative drugs.

Commercial T cell culture medium of international quality 

OptiVitro T Cell Serum-Free Medium

◆ No serum, no xenobiotics, no exogenous growth factors, no need to add serum substitutes 

◆ Excellent performance , supports rapid proliferation and high-density culture of T cells, and can be used in large-scale process flows

◆ Suitable for a variety of T cell activation methods, and can support long-term stable culture (> 14 days)

◆ Available in bottled and bagged form, the first domestic T-bag culture medium, suitable for closed culture system

◆ GMP level , in line with R&D and production requirements, FDA DMF registration (registration number 037572)

◆ Completely independent research and development, stable supply, complete qualifications, and full support for customers' clinical application and commercial transformation 

Creating a Chinese core for cell culture and enabling the rapid application of innovative biological drugs has always been the goal pursued by EXCELL.

Ecosino will continue to be committed to providing customers with international-quality, compliant and stable commercial culture media to help customers quickly achieve clinical application. At the same time, we also look forward to cooperating with more customers to jointly build a golden age of innovative biological drugs.

EXCELL serum-free medium 

01 Compliance and stability: 

GMP level and FDA registration support from R&D to commercialization, enabling rapid declaration of biological drugs.

02 International quality: 

Excellent performance, stable quality, self-developed and self-produced, digital factory, with an annual production capacity of tens of millions liters.

03 Multi-category coverage: 

T/NK/293/MSC/CHO/freeze and other product lines fully cover the CGT and biopharmaceutical fields.

04 Customized services: 

Meet the personalized needs of different projects (formula optimization, packaging customization, etc.) to achieve cost reduction and efficiency improvement.