New high-performance mammalian expression platform
FUJIFILM Diosynth Biotechnologies has developed a high-performance mammalian expression platform "Apollo," which enables the creation of a robust "manufacturing-ready" cell line within 25 weeks, this is thirty percent shorter than previously and, at the same time, giving a five-fold increase in protein productivity.
Biopharmaceuticals are manufactured by genetically modified microbes or mammalian cells. Antibodies are an important class of biopharmaceutical, they are well established as safe and efficacious treatments and are manufactured in high volumes. The structural complexity of these entities means that they are usually produced in mammalian cells.
In the manufacture of antibodies, the following technologies are key to obtaining good cell lines: 1. nature of the host cells used, 2. genetic engineering technology, 3. screening technology and 4. media and feed for cell culture.
"Apollo" is a unique set of technologies established by the expertise, experience and know-how which FDBU and FDBK have been accumulating through their long history in the biopharmaceutical CMO industry, and comprises four key components, 1. a new CHO DG44-derived host cell line6 with proven track record, 2. a novel expression vector7, 3. high throughput screening technology and 4. animal component-free media and feed which maximize cell culture performance.
"Apollo" offers to clients two major benefits:
- 30% shorter development period:
- A manufacturing-ready cell line is available in 25 weeks, which is about thirty percent shorter than previously.
Five-fold increase in protein productivity:
Titers can be increased up to 5 times as high as previously. The developed cell line is stable and maintains high productivity on scale-up.
"Apollo" realizes top-tier performances in the industry and brings about benefit for various stages from early development to clinical and commercial supply. It will contribute to swift launch of innovative, novel biopharmaceuticals through helping clients shorten their development timeline.
FDBU and FDBK are biopharmaceutical CMOs which Fujifilm acquired from Merck&Co.,Inc. in 2011. They operate efficient manufacture of high-quality biopharmaceuticals utilizing the technologies and resources of total Fujifilm group. Fujifilm intends to expand its CMO business, making best of existing, well trusted platforms for microbial culture (pAVEwayTM) and insect-cell culture, along with the "Apollo" platform announced today and by increasing manufacturing capacity to meet clients need.
Provided by Fujifilm