Bangalore: Malaysian Bio-XCell and Strides Acrolab's Malaysian subsidiary, Agila Biotech Malaysia, have sealed a $34.4 million (RM107 million) build-and-lease agreement to establish a customized biotech facility in the Bio-XCell ecosystem in Nusajaya, Johor, Malaysia. The agreement was signed at the BioPharma Asia Convention, which is being held in Singapore from March 19-21, 2013, between Mr Rizatuddin Ramli, CEO, Bio-XCell, and Dr Anand Iyer, CEO, Agila Biotech, Malaysia, replacing an earlier agreement signed in May 2011.

Mr Ramli said that, "Agila Biotech Malaysia 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." Bio-XCell will fund approximately $22 million (RM67.32 million), 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 to be at $13-15 million) will be funded by Agila Biotech Malaysia 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.

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 & finish suite, analytical/ QC/ R&D labs, utilities infrastructure and offices. Agila'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 (500 L expandable up to 2KL) products.

Agila also aims to develop advanced formulation/fill finish facilities to meet its 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), Recombinant Therapeutic Proteins, CMO activities, chemistry and formulation activities for PEGylation, novel formulation development and sterile fill finish facilities for vials, cartridges and lyophilized products. Agila Biotech Malaysia is also building a 15,000 square feet, state-of-the-art biologics R&D facility in Bangalore that will support and complement its operations in Malaysia.