BioTechnique has significantly expanded its capabilities to provide comprehensive aseptic filling and lyophilization services. This strategic move enhances the company’s position as a full-service Contract Research, Development, and Manufacturing Organization (CRDMO), enabling it to support pharmaceutical programs from initial development stages to commercial supply.
Advanced Service Integration
Located in York, PA, BioTechnique’s new offerings are seamlessly integrated with their third-party logistics (3PL) platform. This platform includes controlled warehousing options across a range of temperatures: ambient (15–25°C), refrigerated (2–8°C), frozen (−20°C), ultra-low (−80°C), and cryogenic (−190°C). Such flexibility allows clients to store and manage their products in optimal conditions.
Diverse Filling Formats
The company now supports a variety of filling formats, including vials ranging from 2R to 100H, prefilled syringes, cartridges, and bags. This diverse selection caters to the specific needs of clients, ensuring precision and reliability throughout the filling process. The end-to-end services provided by BioTechnique encompass formulation, compounding, sterile filtration, filling, and packaging.
Comprehensive Lyophilization Development
BioTechnique’s lyophilization cycle development services are robust and thorough. They cover crucial aspects such as formulation support, cycle design and optimization, scale-up, validation, and final product testing. This ensures that each process is inspection-ready and maintains product integrity throughout its shelf life.
Expert Collaboration
To bolster their lyophilization expertise, BioTechnique collaborates with Dr. Serguei Tchessalov, a recognized leader in freeze-drying science. This partnership enhances the effectiveness of their offerings, guiding clients from early development through to commercialization with a focus on quality and efficiency.
Integrated Quality Management
BioTechnique employs the ACE® cloud electronic Quality Management System (eQMS), which enhances documentation control and real-time tracking. This integrated approach ensures that all processes are audit-ready and that clients have access to precise documentation throughout the lifecycle of their products.
3PL Services Supporting Lifecycle Management
BioTechnique’s 3PL services play a critical role in supporting the fill and lyophilization lifecycle. They include:
- Real-time Inventory Monitoring: The company offers fully electronic, real-time digital inventory and temperature monitoring, allowing for tailored access as needed.
- Multi-temperature Storage Solutions: Facilities are equipped to handle various temperature-sensitive products, including drug substances (DS), drug products (DP), excipients, samples, and consumables.
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Efficient Freight Options: BioTechnique provides Good Distribution Practice (GDP)-aligned shipping with real-time tracking and a documented chain of custody, ensuring the safety of temperature-sensitive freight.
Commitment to Quality and Innovation
As a division of PSC Biotech Corporation, BioTechnique is dedicated to offering high-quality sterile injectable fill-finish services. Their state-of-the-art facility is designed to accommodate a wide range of pharmaceutical products, including cytotoxic compounds, therapeutic agents, antibody-drug conjugates (ADCs), and vaccines.
Conclusion
BioTechnique’s expansion of aseptic filling and lyophilization services positions it as a leader in the biotech industry. By integrating advanced cycle development and flexible storage solutions, the company is well-equipped to meet the evolving needs of pharmaceutical partners. This commitment to quality and innovation ensures that clients receive superior support from development to commercialization.
- Enhanced Capabilities: BioTechnique broadens its service offerings for pharmaceutical programs.
- Diverse Formats: A wide range of filling formats and conditions tailored for client needs.
- Expert Collaboration: Partnership with leading experts in lyophilization science.
- Integrated Quality Management: Use of advanced eQMS for real-time tracking and documentation.
- Comprehensive Support: End-to-end services streamline the fill and lyophilization process.
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