The BioTechnique facility encompasses 268,000 sq ft and sits on 39 acres, with opportunities for future expansion. The facility is equipped with 9 cleanroom suits and advanced manufacturing capabilities.
Orders and inventory are tracked using ACE, PSC Software's AI-Powered quality management system (QMS) and workflow automation platform.
Completion of major facility and security upgrades were a part of BioTechnique's process for DEA approval.
New license expands BioTechnique’s capabilities in controlled‑substance manufacturing and secure pharmaceutical development.
YORK, PA, UNITED STATES, March 17, 2026 /EINPresswire.com/ -- BioTechnique is pleased to announce the successful issuance of its Drug Enforcement Administration (DEA) manufacturing and handling license, marking a
significant advancement in the organization’s pharmaceutical development capabilities. This milestone reflects BioTechnique’s rigorous scientific standards, operational excellence, and readiness to support clients working with controlled substances.The licensing process required the development of DEA-compliant standard operating procedures (SOPs) and documentation, followed by extensive review and alignment with BioTechnique’s internal quality systems. The team executed thorough transcription and verification of all regulatory citations, ensured precise tailoring of each SOP to controlled-substance workflows, and conducted detailed digital workflow planning for future-state documentation and mass balance tracking.
BioTechnique also completed major facility and security upgrades, including installation and verification of surveillance, alarm, and physical security systems, along with completion of all required employee background checks. A pre-inspection readiness meeting with the DEA inspector confirmed expectations and inspection scope, followed by a successful preliminary documentation assessment. The comprehensive onsite inspection evaluated facility controls, documentation integrity, and controlled-substance handling processes.
The licensing effort progressed from initial AI-assisted SOP generation in June 2025 to license issuance in December 2025. The use of advanced AI tools significantly accelerated documentation development, allowing the team to concentrate on validation, facility readiness, and compliance strategy.
With the DEA license now in place, BioTechnique expands its ability to support clients requiring controlled-substance handling, high-potency compound processing, and secure, compliant manufacturing environments. This achievement reinforces the organization’s commitment to innovation, regulatory excellence, and the advancement of complex pharmaceutical therapies.
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 supportfrom 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
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