Lyne has been providing manufacturing services to large and mid-size ethical pharmaceutical companies, small biotech start-ups, and virtual companies for more than 30 years. We specialize in the manufacture of oral liquids, powders, semi-solids and liquid unit-dose packaging. Lyne also offers manufacturing services for scheduled drugs and alcohol formulations.
Lyne offers a wide range of manufacturing services from our modern, cGMP-compliant facility including compounding, filling and packaging. We offer liquid filling flexibility with up to eight different filling lines. Lyne’s high-speed rotary fillers have the capacity to fill up to 250 containers a minute. Batch sizes can range from 100 liters pilot scale to 10,000 liters commercial scale. In addition, Lyne has the expertise to meet all regulatory requirements of product development and manufacturing including technology transfer, pilot and engineering batches, commercial services validation and commercial batches. Lyne has a successful track record with FDA pre-approval and post-validation inspections for new and abbreviated drug applications, CMC sections, clinical supplies for late stage Phase III studies, cGMP compliance, and regulatory services.
Lyne’s Capabilities include:
- Clinical manufacturing – Late Stage Phase III
- Technical Transfer
- Commercial manufacturing
- Analytical services
- ICH stability programs
- Validation services
- Regulatory support for NDAs & ANDAs
- Hospital unit-dose liquid packaging
- Scheduled drugs
- Alcohol formulations