Monoclonal Antibodies
One of the largest monoclonal antibodies (mAbs) facilities in India under one roof
340000
Sq Ft
Total cell culture capacity for mammalian products, primarily mAbs
36000
Ltr
Biocon Biologics’ multi-product GLSP-benchmarked/certified monoclonal antibodies (MAbs) facility manufactures, purifies and bulk-fills mammalian cell culture-derived therapeutics. The facility supports late-stage and commercial production, and meets U.S. and European regulatory requirements.
Integrated planning ensures spaces are connected efficiently, while enabling independent functionality. Unique, unidirectional personnel flows exist for both upstream and downstream processing. The final product is sent to formulation and filling facilities, as per market tie-ups and demands. No vaccines, cytotoxic or potent compound materials, hormones, sensitizers or biosafety regulated products are manufactured in the facility.
Hybrid approach to bioreactors:
With single-use bioreactors to develop the seed, and stainless bioreactors connected in series, we have achieved significant reductions in turnaround time, and increased seed availability. Added efficiencies in cleanroom systems, magnetic mixer drives and plug-and-play functionality for seamless addition/ replacement of functional elements, have contributed to significant reductions in capital costs and an improved facility footprint. Quicker changeovers also allow for multi-product manufacturing.
First-of-its-kind customized automated six-fold filling:
Scales up the process considerably, to meet validated processing times. In-line control of process parameters at every step allows for evaluation and quick process decisions.
Dynamic Axial Compression (DAC) columns in chromatography:
Assures consistency in packing efficacy due to automated packing and reduction in the COGS due to lesser resin requirement for packing. A hybrid approach was followed in designing the TFF system wherein the feed vessel was a SUM and the skid was a conventional stainless steel system. The design enabled quick turnaround and product changeover. The Depth Filtration system was designed to handle the filtration area, ranging from 33m2 to 99 m2. The skid also has design capabilities for inline conditioning of load and buffer, thereby reducing time and space requirement.
Reduced cost of drug to customers:
The distribution of equipment towards Stainless Steel (SS) to Single-Use (SU) is well optimized to reduce operational expenses, ultimately reducing the cost-of-drug to customers. A technology transfer laboratory enables the quick and seamless transfer of technology to production scale, helping bring the drug to the market in a timely manner.
Related Links
We have built global scale and world-class capabilities that leverage advanced technologies and an unwavering commitment to quality, to transform...
Biocon Biologics has a proven track record in the science, scale, scope and complexity of biologics manufacturing. Over the years...
