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Services
Preventative maintenance programs, validation support, control system upgrades, freeze drying cycle development, training, upgrades and refurbishments, are just some of the value-adding services we can offer.
FORMULATION & PROCESS DEVELOPMENT
Investigate new technologies developed internally or introduced by our customers:
- Ice nucleation
- Stoppering studies
- Bulk lyophilization
- Process analytical tools
- Quality by Design modeling
- Syringe and vial heat transfer coefficient studies
- Shelf heat transfer enhancements
TECHNICAL CONSULTANCY AND IN-HOUSE ENGINEERING
We can offer assistance in the following areas:
- Assistance with infrastructure and system design
- Process definition
- Facility design
- Clinical and commercial
- New and renovated
- FDA/EMEA compliant
- Compliant material and personnel flows
- Throughput analysis and choke point identification
- Operational procedures
- Staff training
- Equipment specification writing, and testing
- Performance analysis
- Capacity modeling
- Compliance gap analysis
- Streamlining
- Discrete failure analysis
- Product impact analysis
GMP SCALE UP AND TECHNOLOGY TRANSFER
Recent trends in the pharmaceutical industry have highlighted the importance of technology transfer. Mergers and acquisitions, the growth of generics, the closing of plants, and the construction of new ones are all activities that typically involve the transfer of products and processes from one site to another.
New products and methods must also be moved from the development site to a manufacturing site prior to launch. Technical transfer is a specific function required by all Bio-Pharm companies. Technology transfer is critical for the ability to provide uninterrupted supply and the drive to achieve greater efficiency and cut costs.
Our team can assist with:
- New product introduction and scale up
- Physical requirements – materials, environmental conditions, HS&E
- Facility construction – space, load, proximities, infrastructure, validation
- Equipment specifications – capacity, precision, speed, materials of construction, validation
- Analytical transfer – equipment, method assessment, validation
- Process requirements – engineering runs, stability lots, process validation
- Regulatory requirements – change notification, documentation packages (SOP’s, MBR’s, protocols, summary reports), data review and analysis, PAI readiness
- Site transfer
PROFESSIONAL TRAININGS
Several training modules can be delivered at the Tonawanda Lyo Process Lab for hands-on experience, or delivered either at the customer site. Qualified personnel with expertise in the subject matter teach the trainings described below.
INTRODUCTION TO LYOPHILIZATION (FREEZE-DRYING) AND CYCLE DEVELOPMENT
Overview of the lyophilization process: theory, equipment, formulation, analytical support, validation, cycle development and scale-up.
Duration: 3 days (4h lectures and 4h laboratory activities each day).
ASEPTIC MANUFACTURING
Basics of clean room operations, basic microbiology, aseptic techniques, gowning, clean room design and control, environmental monitoring, glassware and equipment preparation, solution processing (compounding), sterilization and filtration, process simulation/media fill, formulation and drug development.
Duration: 4h lectures.
CURRENT GOOD MANUFACTURING PRACTICE (cGMP)
Application of cGMP in the production of pharmaceuticals developed using biotechnology (biopharmaceuticals). Selections from Title 21 of the CFR 210/211, and relevant ICH and FDA guidance document.
Duration: 4h lectures.
Team
Our highly skilled professionals have an extensive experience gained in the field of parenteral development and facility operation. Their technical experience includes freeze drying technology, aseptic processing, formulation, filtration science and sterilization.