221 and 222, Building 450, MN Park, Synergy Square 1, Genome Valley, Shamirpet, Hyderabad , Telangana - 500078, India
Piramal offers development and manufacturing services for large molecules through our associate company Yapan Bio. Based in Hyderabad, India, Yapan Bio has a proven track record in the successful development and manufacturing of various large molecules. Yapan specializes in process development, scale-up, and GMP-compliant manufacturing of vaccines and biologics, including high-containment product classes (up to BSL-2+), recombinant vaccines, viral vector-based vaccines, gene therapies, monoclonal antibodies, therapeutic proteins, and other complex biologics for Phase I/II human clinical trials.
Yapan Bio excels in vaccine development, offering services for recombinant vaccines (protein antigens, virus-like particles, nano-particles), viral vector-based vaccines, RNA vaccines, and DNA vaccines. This expertise enables them to contribute significantly to the development of diverse vaccine candidates for various infectious diseases and medical conditions.
Yapan Bio offers diverse biologics services, including gene therapy (oncolytic viruses, vectors), monoclonal antibodies, and therapeutic proteins. Their expertise contributes significantly to advancing the development and manufacturing of biologic therapies for various medical needs.
Yapan Bio excels in vaccine development, offering services for recombinant vaccines (protein antigens, virus-like particles, nano-particles), viral vector-based vaccines, RNA vaccines, and DNA vaccines. This expertise enables them to contribute significantly to the development of diverse vaccine candidates for various infectious diseases and medical conditions.
Yapan Bio offers diverse biologics services, including gene therapy (oncolytic viruses, vectors), monoclonal antibodies, and therapeutic proteins. Their expertise contributes significantly to advancing the development and manufacturing of biologic therapies for various medical needs.
The facility provides a comprehensive suite of services essential for biopharmaceutical development. This includes expertise in cell line development, optimizing and scaling up processes for high product titer, stability, and consistent manufacturing output. The site excels in both upstream and downstream development, ensuring efficient production. Additionally, the capabilities extend to analytical method development & qualification, formulation development, and conducting stability studies, ensuring thorough characterization and reliable performance of biologic products throughout their lifecycle.
The facility offers specialized services for process development and optimization. This includes establishing and qualifying small-scale models for various unit operations, classifying critical process parameters and product quality attributes, and employing Design of Experiments (DoE) to determine optimal ranges for these parameters. They execute experiments meticulously and generate comprehensive data and reports essential for regulatory filings, ensuring the robustness and compliance of the processes.
The facility offers comprehensive bioprocessing capabilities, including cell and virus seed banking, utilizing various bioreactors such as rocker, stirred tank, and adherent cell bioreactors up to 1,000L scale. They employ single-use technologies and maintain a facility for handling high containment/infectious agents (BSL-2+). Additionally, they provide on-site fill/finish services for aseptic formulation, lyophilization, and liquid in vials, alongside conducting stability studies to ensure product quality and compliance.
The facility offers a range of cell culture and fermentation services, including mammalian cell culture, insect cell culture, and microbial fermentation.
Capabilities to support a broad spectrum of expression/technology platforms for novel product development.
Experience in developing novel recombinant vaccines, gene therapy, and monoclonal antibody products for global biotechnology companies.
Piramal's ADCelerate program expedites Phase-I appropriate ADC drug substance and drug product delivery, enabling faster access to patients in clinical trials.
Embracing a culture of quality, we integrate rigorous quality checks and balances throughout our operations, ensuring consistent and exceptional product quality. Our teams are dedicated to upholding the highest quality standards at all stages of the development process.
