BioTechnique LLC
Description
BioTechnique LLC is a Contract Research, Development and Manufacturing Organization (CRDMO) founded in 2014. The company provides lyophilization and therapeutic sterile injectable fill-finish solutions, catering to both large and small investigational, clinical stage, or commercial batch sizes. With a state-of-the-art facility spanning 158,000 square feet situated on 39 acres, BioTechnique has the potential for expansion to meet the growing demands of the pharmaceutical industry.
Services include:
- Regulatory Services
- Containment
- Injectables
- Clinical Dose
- Packaging
- Clinical Packaging
- Analytical Services
- 505(b)(2)
- Accelerated Stability Studies
- Animal Health
- Aseptic Fill/Finish
- Assay Development
- Bioanalytical Services
- Biodiagnostics
- Biological Testing
- Biologics
- Process Development
- Bioprocess Validation
- Bioprocessing
- Disposable/Single-Use
- Calibration
- Lab Services
- Chemical Analysis
- Chromatography
- CIP Process Systems
- Clean in Place / Sterilization in Place (CIP/SIP)
- Cleaning Equipment
- Chemistry (CMC)
- Manufacturing
- Sourcing
- Consulting
- Quality Management Systems
- Records Management
- Regulatory
- Contaminant Analysis
- Contract Development and Manufacturing (CDMO)
- Contract Manufacturing (CMO)
- Contract Packaging
- Contract Research (CRO)
- Downstream Processing
- Endotoxin Testing & Removal
- Excipients
- Testing
- Filling
- Cartridge
- Syringe
- Vials
- Formulation Development
- IND/NDA Submissions
- Lyophilization
- Aseptic Fill-Finish
- Clinical Trial Materials
- Cytotoxic & High Potency Compounds
- Dose Form
- Non-Sterile
- Sterile
- Generics
- High Containment Operations
- Inhalables
- Liquids
- Microbial-based Therapeutic Proteins
- Nasal Delivery
- Oligonucleotides
- Ophthalmics
- Parenterals
- Large Volume
- Small Volume
- Peptides
- Proteins
- Solutions & Suspensions
- Suppositories
- Pre-filled
- Vaccines
- Materials Analysis
- Measuring & Testing Technology
- Micro FT-IR Analysis
- Mixing & Blending
- Glass
- Labelling
- Parenterals Development
- Ampule
- Particle Size Analysis
- Particle Size Classification
- Physical Testing
- Pilot-Scale Filling
- Preformulation
- Process R&D
- Project Management
- Quality QA/QC
- R&D Services
- Raw Materials Analysis
- Regulatory Affairs Consultants
- Scale-Up
- Screening
- Classifying
- Stability Studies
- Stability
- ICH
- Sterile Filling
- Sterilization
- Storage
- Technology Transfer
- Logistics
- Trays
- UV-VIS Spectrophotometer Analysis
- Validation
- Warehousing
BioTechnique LLC is committed to supporting and guiding customers at every stage of their journey, tailoring their approach to meet specific needs with precision and care. For more information, please visit biotechnique.com.