BioTechnique LLC
BioTechnique® is a full-service CRDMO providing sterile injectable fill-finish services, formulation development, analytical testing, regulatory support, and logistics solutions. Committed to excellence, innovation, and high-quality manufacturing, it serves clients worldwide with a focus on patient safety and product integrity.
Industries
Nr. of Employees
medium (51-250)
BioTechnique LLC
250 Cross Farm Lane, York, Pennsylvania, 17406 USA
Services
On‑site aseptic filling, compounding and finishing for vials, syringes, cartridges and bags, including isolator‑based sterile testing and 100% visual inspection.
Formulation support, lab‑scale lyophilization, thermal analysis and cycle design with scale‑up to GMP commercial lyophilization.
Formulation optimization for injectables and lyophilized products plus analytical method development and validation to support QC and regulatory filings.
Endotoxin, bioburden and sterility testing along with rapid species identification using mass spectrometry‑based methods.
Regulatory strategy, submission assistance (IND/NDA), compliance consulting, training, and dedicated project management with risk mitigation and real‑time reporting.
Temperature‑controlled warehousing across ambient to cryogenic conditions, electronic inventory, real‑time temperature monitoring, and logistics services including labeling and QC testing.
On‑site aseptic filling, compounding and finishing for vials, syringes, cartridges and bags, including isolator‑based sterile testing and 100% visual inspection.
Formulation support, lab‑scale lyophilization, thermal analysis and cycle design with scale‑up to GMP commercial lyophilization.
Formulation optimization for injectables and lyophilized products plus analytical method development and validation to support QC and regulatory filings.
Endotoxin, bioburden and sterility testing along with rapid species identification using mass spectrometry‑based methods.
Regulatory strategy, submission assistance (IND/NDA), compliance consulting, training, and dedicated project management with risk mitigation and real‑time reporting.
Temperature‑controlled warehousing across ambient to cryogenic conditions, electronic inventory, real‑time temperature monitoring, and logistics services including labeling and QC testing.
Expertise Areas
- Sterile injectable manufacturing
- Lyophilization development and commercialization
- Formulation development for injectables
- Analytical chemistry and QC testing
Key Technologies
- Lyophilization (freeze‑drying)
- HPLC/UPLC chromatography
- FTIR spectroscopy
- UV/Visible spectroscopy
News & Updates
Visit by Congressman Smucker to the BioTechnique® facility highlighting industry engagement.
Official opening ceremony of the new BioTechnique® facility with Governor Wolf.
Announcement of Laura Wahlen joining the team to expand microbiology capabilities.
A white paper discussing microbial identification techniques using MALDI-TOF mass spectrometry.
Visit by Congressman Smucker to the BioTechnique® facility highlighting industry engagement.
Official opening ceremony of the new BioTechnique® facility with Governor Wolf.
Announcement of Laura Wahlen joining the team to expand microbiology capabilities.
A white paper discussing microbial identification techniques using MALDI-TOF mass spectrometry.