UNIQTAINERR BIOTECH PRIVATE LIMITED

In their own words

We have provided upstream bioprocess support to numerous bio-pharma industries, gaining invaluable insights into the challenges of "Cleaning and Validation." Cleaning on the manufacturing shop floor can be a laborious task, particularly when it involves removing traces of API from previous batch runs, as well as residues from cleaning agents and any synergistic interactions. The primary objective of validating a cleaning process is to guarantee adherence to federal and other regulatory standards. The industry is moving towards faster and simpler solution doing away with age old cumbersome and costly methods • Most of the GMP manufacturing facilities are turning towards Single – Use - Platforms • As they have easier compliance and validation from all standard regulations • Reduces CAPEX cost for CIP & SIP • Reduces additional validation and documentation. With the industry shifting towards Single-Use Platforms, it presents an opportunity to eliminate the aforementioned challenges. Recognizing the global shift towards Single-Use platforms as the optimal solution, we aligned with Prime Minister Modi's vision of Make in India and embarked on a journey to leverage our expertise. Thus, Uniqtainerr Biotech Private Limited was established with a focus on delivering affordable, customized solutions to the industry. UniQTainerr™ specializes in tailor-made solutions, catering to specific needs with precision. Our solutions span a wide range of applications: VACCINES: Our flexible and scalable designs empower clients to manage the entire manufacturing process, from upstream to downstream, including fill-finish stages and intermediary steps. FILL FILTRATION: Automated aseptic fluid management and precise cold chain control significantly enhance drug substance manufacturing. Our technologies minimize product loss during single-use bioprocess container handling, employing accurate automated filtration and aliquotation, alongside controlled freezing and thawing. MONOCLONAL ANTIBODY (mAbs): Precision handling is crucial for maintaining the efficacy of antibodies throughout development, production, and logistics. Controlled freezing and thawing rates are pivotal for superior results, and our single-use technologies offer the flexibility and scalability required. CELL THERAPY: UniQTainerr™ provides comprehensive single-use solutions for cell therapy, covering primary packaging, fluid management, ultra-cold cryogenic freezing, storage, and shipping—all meeting stringent regulatory standards. GENE THERAPY: Addressing the complexities of gene therapy, our specialized single-use solutions optimize manufacturing processes for Advanced Therapy Medicinal Products (ATMPs). We offer sterile systems, customizable liquid management, and advanced freezing and storage options. CELL BANKING: Ensuring high recovery rates and optimal viability post-thawing is essential for cell banking. Our single-use bioprocess containers facilitate controlled, scalable freezing, streamlining aliquoting and automated aseptic dispensing with precise cryogenic freezing capabilities down to -180°C (-292°F). UniQTainerr™ is committed to advancing bioprocessing with cutting-edge single-use technologies that enhance fluid and cold chain management across various applications.

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