Good News | BioEngine Sci-Tech Co, Ltd’s Vigor-S101S Serum-Free Medium For Insect Cells Obtains FDA DMF Filing To Accelerate Your Biologics Submissions

Recently, Vigor-S101S Serum-Free Medium for Insect Cells and its matched supplement independently developed by BioEngine Sci-Tech Co, Ltd have officially submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) and obtained the DMF filing number 042513. This product has supported three commercial production projects, as well as multiple vaccine and gene therapy programs at IND and clinical stages.

DMF Filing Number for Vigor-S101S Serum-Free Medium for Insect Cells and Supplement: 042513.

 

 

What is FDA DMF Filing?

A Drug Master File (DMF) is a complete set of technical documents submitted by enterprises to the FDA, covering product Chemistry, Manufacturing and Controls (CMC) information. Culture media belong to Type II DMF under the FDA filing system. After enterprises submit complete English documents, the FDA conducts administrative review and issues a filing number.

 

What benefits can this bring to you?

For customers developing and manufacturing biologics with Vigor-S101S Serum-Free Medium for Insect Cells, this DMF filing can improve your FDA submission efficiency significantly.

1. It simplifies submission documents. Our DMF technical dossier contains complete CMC data of the medium. Customers do not need to resubmit such data when filing IND or BLA applications with the FDA, thus streamlining the whole submission package.

2. Full technical preparations are completed in advance. The DMF documents we submitted cover complete records including medium composition, product specifications, test methods, manufacturing standards, process validation, shelf-life verification and packaging information, all key technical materials the FDA focuses on during pharmaceutical review.

 

Besides, Eden series serum-free media for CHO cells from BioEngine Sci-Tech Co, Ltd have also completed FDA DMF filing.

 

The Baculovirus Expression Vector System (BEVS) based on insect cells boasts multiple advantages including high protein expression level, eukaryotic post-translational modification, simultaneous expression of multiple exogenous genes and high biosafety, so it is widely applied in basic research and large-scale production of recombinant proteins. BioEngine's R&D team has carried out research on serum-free suspension culture technology of insect cells since 1995. Through continuous upgrading and iteration, a variety of high-performance serum-free media have been launched.

The Vigor series is BioEngine's latest portfolio of serum-free media for insect cells, supporting high-density large-scale culture of Sf9 and High Five insect cells and efficient production of recombinant proteins. It has been successfully applied in the production of subunit vaccines, VLP vaccines, rAAV and other biological products.

 

Vigor-S101S

Insect cell culture medium without serum.

and its additives.

 

Product Features

1. Serum-free, xeno-free and protein-free formulation

2. Supports high-density insect cell culture and efficient protein expression based on BEVS

3. Compatible with both Sf9 and High Five cell lines

4. Suitable for large-scale production of subunit/VLP vaccines, recombinant proteins and rAAV

 

Product Advantages

1. Adopted in numerous R&D and production projects of subunit/VLP vaccines and rAAV gene therapy, with culture performance superior to most competing media

2. Advanced CMPM manufacturing process ensures excellent batch-to-batch consistency

3. Completed FDA DMF filing to facilitate your regulatory submission process

4. Dual certifications of ISO13485: 2016 and MDSAP, with all production activities complying with GMP standards

5. Professional technical support team with solid expertise and abundant project experience to provide comprehensive customized solutions

 

Product Performance

When cells are seeded at 1×10⁶ cells/mL and passaged every 48 hours in Vigor-S101S Serum-Free Medium for Insect Cells, Sf9 cells can reach a stable density of 3–5×10⁶ cells/mL with a population doubling time of 21–30 hours for long-term stable subculture.

 

The maximum cell density of Sf9 cells in this medium can hit 12–14×10⁶ cells/mL, featuring faster growth rate, higher peak density and longer stable culture period compared with imported media.

 

When producing seed virus with Sf9 cells in Vigor-S101S, the virus titer can exceed 10⁸·⁵ TCID₅₀/mL, remarkably outperforming other commercial media. In addition, Sf9 cells cultured in this medium achieve high protein yields.

 

 

For example, the expression level of human influenza HA protein can reach over 100 mg/L, which is far better than competing products.