Welcome to Lab4Life – The Lyophiliser Process Development Laboratory.

The Lab4Life team comprises industry experts who assist clients globally in product development, scaling, and qualification. To enhance this support, IMA Life has established a dedicated development lab within its manufacturing facility in Tonawanda, NY. The team also focuses on discovering innovative processes and technologies and is eager to share new advancements.

The lab includes certified cleanrooms with Laminar air flow, pilot scale and freeze dryers. In addition, there is an analytical support lab equipped with formulation, filling, and freeze-drying systems, allowing the development of pharmaceutical and biopharmaceutical products in batch sizes up to 20 liters. Lyophiliser Process Development Laboratory is a great partner from lab testing to commercial-scale.

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, which results to be central 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 either at the Tonawanda Lyo Process Lab or at the customer site. Qualified personnel with expertise in the subject matter teach the following trainings:

• INTRODUCTION TO LYOPHILIZATION (FREEZE-DRYING) AND CYCLE DEVELOPMENT
• ASEPTIC MANUFACTURING
• CURRENT GOOD MANUFACTURING PRACTICE (cGMP)