Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of global pharmaceutical company Lupin, has commissioned a dedicated Oncology Block at its Vizag facility in India, significantly expanding its contract development and manufacturing organization (CDMO) capabilities for high potent active pharmaceutical ingredients (HPAPIs). The new high-containment unit addresses growing global demand for oncology drug development and production by supporting clients across the entire oncology development lifecycle from preclinical research to commercial manufacturing.
Advanced Manufacturing Infrastructure
The new facility spans 4,270 square meters and features sophisticated manufacturing capabilities designed specifically for oncology API production. The unit is equipped with 20 reactors ranging from 250L to 2000L capacity, complemented by over 20 isolators and advanced containment systems that ensure exposure levels of ≤0.05 μg/m³. The facility incorporates flexible scale-up capabilities supporting batch ranges from 1-35 kg, along with comprehensive environmental controls maintaining temperatures ≤25°C and relative humidity ≤45%.
"The inauguration of our Oncology Block in Vizag exemplifies our commitment to advancing oncology research and manufacturing," said Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions. "This state-of-the-art facility enhances our capacity to produce high-quality APIs and develop impactful therapies that benefit patients globally."
Integrated Development and Manufacturing Platform
The facility integrates a Process Development Laboratory with a dedicated Quality Control laboratory, enabling comprehensive services including early-stage route scouting, analytical development, process optimization, and validation within a single location. This integrated approach, supported by scientists with specialized HPAPI expertise, ensures seamless transition from lab-scale synthesis to full-scale commercial manufacturing.
The oncology block features isolator-based operations at every process step, integrated SCADA systems, and a robust effluent detoxification system that complies with global regulatory standards while adhering to Lupin's quality and environmental safety protocols.
Strategic CDMO Positioning
Dr. Toumi emphasized the facility's role in LMS's evolution as a dedicated CDMO partner for oncology innovators. "This marks a major milestone in LMS's evolution into a dedicated and trusted CDMO partner for oncology innovators," he stated. "With a focus on containment excellence, scalable solutions tailored to each phase, and scientific rigor, this investment enables our global clients to deliver life-changing oncology treatments to patients more quickly, while upholding the highest safety and compliance standards."
The expansion strengthens LMS's position as a global CDMO partner by combining Lupin's scientific expertise with advanced containment and regulatory capabilities. The facility supports efficient development of oncology treatments from concept to commercialization, providing clients with a comprehensive ecosystem for oncology drug development and manufacturing.
