BioTechnique® Expands Aseptic Filling & Lyophilization Services, Adding Flexible Formats and Advanced Cycle Development for Clinical and Commercial
March 6, 2026 | Press Release
York, PA — BioTechnique®, a fullservice CRDMO, announced expanded aseptic fillfinish and lyophilization capabilities supporting pharmaceutical programs from development through commercial supply. These services are integrated with BioTechnique’s thirdparty logistics and storage platform, offering controlled warehousing across ambient (15–25°C), refrigerated (2–8°C), frozen (−20°C), ultralow (−80°C), and cryogenic (−190°C) conditions.
The platform now supports vials (2R–100H), prefilled syringes, and cartridges, with end-to-end processes including formulation, compounding, sterile filtration, filling, stoppering, optional lyophilization, capping, QC testing, 100% visual inspection, labeling, and packaging—powered by the ACE® cloud eQMS for real time documentation.
Integrated Lyophilization Expertise
BioTechnique’s lyophilization cycle development services cover formulation support, cycle design/optimization, scale up, validation/QA, and final product testing, enabling robust, inspection ready processes that protect product integrity over shelf life. The company’s lyo leadership includes collaboration with Dr. Serguei Tchessalov, a globally recognized SME in freeze drying science and tech transfer, strengthening client outcomes from early development through commercialization.
Highlights
- Filling formats: Vials (2R–100H), syringes, cartridges, and bags; aseptic line design for precision and reliability.
- End-to-end process: Formulation → compounding → sterile filtration → filling → stoppering → optional lyo → capping → visual inspection → quality control testing → labeling/packaging.
- Lyophilization product cycle development: Formulation, optimization, scaleup/transfer, validation & QA, final product testing.
- Integrated quality: ACE® eQMS for controlled documentation, real time tracking, and audit ready reporting.
- CRDMO model: In house development, filling, lyo, QC, storage, and logistics—fewer handoffs, faster timelines.
3PL Services Supporting the fill/lyo lifecycle:
- Inventory Monitoring: Fully electronic, realtime digital inventory and temperature monitoring with optional custom access.
- Multitemperature storage: Ambient (15–25°C), refrigerated (2–8°C), frozen (−20°C), ultralow (−80°C), cryogenic (−190°C) for DS/DP, excipients, samples, and consumables.
- Freight Options: GDPaligned shipping with realtime tracking and documented chain of custody for temperaturesensitive freight.
About BioTechnique
BioTechnique, a division of PSC Biotech Corporation, is a full-service Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in cytotoxic and therapeutic sterile injectable fill-finish services. BioTechnique provides comprehensive support from investigation and clinical stages through commercialization, batch sizes both large and small.
BioTechnique operates a state-of-the-art facility designed to handle a diverse range of pharmaceutical products, including cytotoxic and highly potent compounds, therapeutics, antibody-drug conjugates (ADCs), monoclonal antibodies, suspensions, and vaccines. Supported by an environmentally controlled warehouse and adaptable manufacturing systems, BioTechnique is committed to delivering high-quality fill-finish solutions.
For more information on BioTechnique’s capabilities, visit www.biotechnique.com.
Media Contact:
BioTechnique Business Development Group
(717) 377-3547