Malaysian Bio-XCell and Agila Biotech signed a $34.4 million Build-and-Lease Agreement for the establishment of a customized biotech facility located in the Bio-XCell biotechnology park and ecosystem in Nusajaya, Malaysia.

“Agila Biotech is indeed poised to be a major anchor tenant for the Bio-XCell ecosystem and we are extremely pleased to be able to offer our services and support for this promising project," said En. Rizatuddin Ramli, CEO of Bio-XCell.

Bio-XCell will fund $22 million to be provided under the Build-and-Lease Agreement with Agila Biotech, which will cover the construction of the building and part of the equipment. All other related state-of-the-art equipment, integration service and testing of this turnkey project (estimated at $13-15 million) will be funded by Agila Biotech from internal accruals and funding from external sources.

Work on the facility for the end-to-end manufacturing of biologics located on an 8.77 acre plot is expected to start as soon as all necessary clearances and permits have been obtained and all supplemental agreements have been executed. Both parties are aiming for the R&D and manufacturing facilities to be operational by end 2014.

Agila Biotech plans to incorporate into its facility at Bio-XCell, the “next-generation” technology platforms which revolutionize the way biomolecules are developed, manufactured and commercialized. It is built around a unique platform that features the innovative application of single-use component technology and transforming biomanufacturing economics, thus reducing deployment of new manufacturing capacity from 3-5 years to a faster 12-18 months. There's also a significant capital investment savings compared to conventional approaches.

“Successful foray into the biologics space would require building a state-of-the-art infrastructure and strong technical foundation to support three pillars for a successful biotech business," said Dr. Anand lyer, CEO of Agila Biotech. He added that the three pillars are a strong pipeline of products; partnering capabilities; and novel formulations/ delivery capabilities, all of which will be found in their new facility planned in Malaysia.

Iyer also noted that the facility in Bio-XCell represents a strategic move to further bolster Agila Biotech’s manufacturing presence in the region and tap into unmet global demand and window of opportunity in biologics. The proposed facility at Bio-XCell will include a mammalian cell culture single-use technology manufacturing suite, a microbial fermentation single-use technology manufacturing suite, a fill and finish suite, analytical/ QC/ R&D labs, utilities infrastructure and offices.

Agila Biotech's plans for their facility at Bio-XCell include the development of a state-of-the-art, multi-product, scalable manufacturing facility with a production capacity for mammalian (2KL expandable up to 8KL) and microbial (500L expandable up to 2KL) products. It also aims to develop advanced formulation/fill finish facilities to meet Agila Biotech’s business model which will support the manufacturing of internal pipeline products as well as CMO activities. These facilities will be able to support the production of Recombinant Monoclonal Antibodies (mAbs) from DS to DP, Recombinant Therapeutic Proteins from DS to DP, CMO activities for DS and DP, chemistry and formulation activities for PEGylation, novel formulation development and sterile fill finish facilities for vials, PFS, cartridges and lyophilized products.

Agila Biotech joins Biocon, MetEx and Glycos Biotechnologies as the early entrants into the Bio-XCell ecosystem. The site is supported by a network of five seaports and two international airports. The ecosystem at Bio-XCell is designed for industrial and healthcare biotechnology with a focus on manufacturing and R&D.