Renaissance
Renaissance Lakewood, LLC is a US-based contract development and manufacturing organization for pharmaceutical and biotech companies, specializing in nasal sprays and sterile injectable dosage forms. With over 20 years of experience, they provide comprehensive services from development to commercial launch, including manufacturing, testing, and regulatory support. They are committed to producing safe, reliable, and life-saving medicines, and have invested heavily in state-of-the-art facilities and equipment to support their clients' needs. They played a key role in the development and manufacturing of neffy®, the world's first needle-free nasal spray for life-threatening allergies, approved by the FDA and now commercially available in the US.
Industries
Nr. of Employees
large (251-1000)
Renaissance
Lakewood, New Jersey, United States, North America
Services
Formulation design, excipient selection, device compatibility assessment and development support for unit-dose, bi-dose, and multi-dose intranasal spray products.
Analytical method development, validation, QC testing, microbiology testing, spray characterization and stability testing to support release and regulatory submissions.
GMP aseptic filling and finish operations for sterile small-volume parenterals and intranasal sprays, with dedicated clinical and commercial suites and RABS-equipped fillers.
Assembly, labeling, blistering, cartoning, serialization and case packing for intranasal formats with high-throughput packaging lines and recent capacity expansion to support commercial demand.
Support for commercial batch production, supply planning and launch readiness including scale-up of processes and capacity to meet market demand.
Implementation and use of digital OEE and frontline data capture to increase production visibility, drive preventive maintenance, and support continuous improvement initiatives.
Formulation design, excipient selection, device compatibility assessment and development support for unit-dose, bi-dose, and multi-dose intranasal spray products.
Analytical method development, validation, QC testing, microbiology testing, spray characterization and stability testing to support release and regulatory submissions.
GMP aseptic filling and finish operations for sterile small-volume parenterals and intranasal sprays, with dedicated clinical and commercial suites and RABS-equipped fillers.
Assembly, labeling, blistering, cartoning, serialization and case packing for intranasal formats with high-throughput packaging lines and recent capacity expansion to support commercial demand.
Support for commercial batch production, supply planning and launch readiness including scale-up of processes and capacity to meet market demand.
Implementation and use of digital OEE and frontline data capture to increase production visibility, drive preventive maintenance, and support continuous improvement initiatives.
Expertise Areas
- Nasal spray formulation and device integration
- Aseptic fill–finish and sterile manufacturing
- Analytical testing, microbiology and method validation for spray products
- End-to-end development and technology transfer from R&D to commercialization
Key Technologies
- Aseptic fill–finish systems
- Restricted access barrier systems (RABS)
- Spray characterization instrumentation
- High-speed assembly and packaging lines
News & Updates
Global CDMO makes additional investment in Ocean County, NJ campus.
Renaissance Lakewood, LLC is proud to manufacture neffy®, now available in the US.
Official opening of a new 67,000 sq ft warehouse at the headquarters in Lakewood, NJ.
Eric Kaneps, VP, Sales and Marketing, discusses innovation and challenges in nasal spray development.
Overview of Renaissance's support for nasal product development and manufacturing.
Global CDMO makes additional investment in Ocean County, NJ campus.
Renaissance Lakewood, LLC is proud to manufacture neffy®, now available in the US.
Official opening of a new 67,000 sq ft warehouse at the headquarters in Lakewood, NJ.
Eric Kaneps, VP, Sales and Marketing, discusses innovation and challenges in nasal spray development.
Overview of Renaissance's support for nasal product development and manufacturing.