BioTechnique LLC

BioTechnique® is a full-service Contract Research, Development, and Manufacturing Organisation (CRDMO) specialising in cytotoxic and therapeutic sterile injectable fill-finish services.

Established in 2014, BioTechnique operates from a state-of-the-art facility located at 250 Cross Farm Lane, York, Pennsylvania. This expansive 158,000-square-foot facility, situated on 39 acres, offers potential for future expansion to meet the evolving demands of the pharmaceutical industry. The company provides comprehensive services throughout the pharmaceutical development lifecycle, from investigational and clinical stages to commercial production. With a commitment to precision and care, BioTechnique tailors its approach to meet the specific needs of its clients, ensuring the highest quality standards are upheld.​

Key Products and Services:

Manufacturing: Aseptic vial filling for liquid and lyophilised products, accommodating vial sizes from 2mL to 100mL and fill volumes from 0.2mL to 100mL. ​
LeadIQ

Lyophilisation Cycle Development: Expertise in developing and optimising freeze-drying cycles to enhance product stability and shelf life.​

Quality Laboratory: Comprehensive analytical services, including assay development, bioanalytical services, and stability studies, ensuring product quality and compliance.​
PharmaSource

Regulatory and Project Management: Support for regulatory submissions, project planning, and management to facilitate timely and successful product development.​

Third-Party Logistics (3PL): Warehousing and distribution services to streamline supply chain operations.​

In addition to its contract manufacturing services, BioTechnique is actively engaged in research, exploring cutting-edge technologies to drive advancements in medical treatments. The company employs ACE®, a cloud-based electronic Quality Management System (eQMS), to create and track records, documents, and dynamic reports, ensuring compliance and efficiency.

BioTechnique's dedication to supporting clients at every stage of their journey, combined with its state-of-the-art facilities and comprehensive service offerings, positions it as a trusted partner in the pharmaceutical manufacturing industry.