The Facility of the Year Award (FOYA) Honorable Mention category recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
Biocon Biologics is one of three Honorable Mention Award winners this year. The other two are Locus Biosciences and the Raymond G. Perelman Center for Cellular and Molecular Therapeutics at Children’s Hospital of Philadelphia.
This project team demonstrated focused efforts to minimize the environmental impact of a large facility and demonstrated superior execution in managing construction safety. Additionally, several of the design elements and execution strategies they implemented showed a focus on ensuring a robust supply chain while focusing on COGM (Cost of Goods Manufactured) reduction.
A Leader in Global Biologics
Biocon Biologics Limited is a fully integrated global biosimilars organization and a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. In 2019 Biocon Biologics decided they wanted to consolidate the development, manufacturing, and commercialization operations for biosimilars into one facility, the Biocon Biologics Manufacturing Plant (B3).
The facility is located at Biocon Park in Bangalore, India, a 100-acre integrated complex. B3 is a mAbs manufacturing facility with 6000 L production bio reactor scale. The facility includes both production and laboratory space and is intended to be used for commercial and clinical manufacturing for global markets. B3 is designed for multiproduct operations with upstream and downstream processing and an in-process quality control testing lab. The adjacent warehouse is fully equipped to complete all the operations associated with biologics manufacturing from the receipt of raw materials to the shipment of bulk mAb/protein.
While Biocon Biologics pursues its purpose of using biotechnology to develop therapies that heal the world, it is equally concerned about the health of the planet and the depleting ecological balance. The Company incorporated environmentally friendly elements into the construction and ongoing operation of B3. The excavated soil of the building was reused for back-filling, reducing solid waste generation.
Ongoing daily efforts are made to reduce water use - liquid waste is piped to one of three tanks (two underground and one above), pumped to a centralized ETP for treatment, and used for irrigation. All roof surfaces are connected to a rainwater harvesting tank and used for irrigation, cooling towers, and flushing. Recovered condensation is sent back to the boiler and effluent from the clean utility systems is reused for the cooling tower.
Energy efficiency was also considered when designing the layout of the building. All offices and conference rooms are located at the northeast and east sides of the building because those sides receive less intense sunlight. Noncritical areas such as staircases, service shafts, and loading bays are located on the south and west sides of the building where the sunlight is the most intense. Services which can be housed in ventilated areas like chillers, AHU plants, and cooling towers are located on the top floor with a covered roof. All clean utilities are planned within the building, minimizing required pumping and other energy loads due to reduced pipe connection lengths.
Safety was also of utmost importance while constructing the project. All contractors and vendors were provided with safety induction training and the project safety plan and asked to provide a Hazard Identification and Risk Assessment for activities performed onsite. The collaborative approach and rigorous planning resulted in a project with close to three million labor hours with zero lost time incidents.
Biocon Biologics operates on the belief that everyone has a right to affordable, high-quality medicines. From design and construction through product delivery, they remained focused on this belief incorporating cost savings throughout resulting in a project that was completed under budget by 35 million dollars. B3 also has ongoing policies and procedures in place that could result in a reduction in the cost to produce medicines. For example, Biocon Biologics’ drug substance manufacturing unit capacity increased by 6-fold after construction of the B3 facility impacting cost optimization and reducing the production cost per unit.
This facility was delivered within the key deliverables of safety, cost, and timeline which has helped Biocon Biologics Limited mission to provide affordable healthcare and reach more patients worldwide.
S.P. Vivek, Senior Director, Projects, and Engineering
Nominate Your Facility for the 2022 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2022 FOYA program winner. Applications must be submitted by 19 November 2021.
Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...
Following the recent surge in popularity of mRNA technology due to Covid-19 vaccines, we are beginning to realise its impact and potential in this field and for oligonucleotides. However, we face a steep learning curve in understanding the diversity and specifics of the manufacturing chain that make this new generation of RNA drug products completely different from traditional biologics (e.g....