Lab
Lab4life
Tonawanda, NY, USA
Welcome to Lab4Life – The Lyophiliser Process Development Laboratory
The Lab4Life team includes a number of industry experts who provide assistance to customers worldwide with product development, scale up and qualification. To enhance this offering, IMA Life has built a development laboratory at the manufacturing facility in Tonawanda, NY.
The team is also dedicated to discovering innovative processes and technologies and is ready to share new developments.
The Lyophiliser Process Development Laboratory consists of a certified clean room and an analytical support laboratory. In addition, formulation, filling and freeze-drying equipment is available to develop pharmaceutical and biopharmaceutical products in batch sizes up to 20 litres.
Lyopedia
We share our knowledge. Explore the collection of our scientific publications on the freeze-drying process.
Publications
White paper
The success of freeze-drying.
17 min
Brands: IMA S.p.A. – LIFE Division Bologna, IMA Life North America Inc.
10 min
Brands: IMA S.p.A. – LIFE Division Bologna
6 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
Case study
Quality by design cycle optimisation and equipment capability determination for vaccine placebo.
4 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
4 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
White paper
An overview of design space construction.
3 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
4 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
3 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
7 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
5 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
12 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
9 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
10 min
Brands: IMA Life
6 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
10 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
Case study
Navigating the COVID pandemic using Augmented Reality to aid in Pharmaceutical Manufacturing.
11 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
5 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
White paper
Freeze-Drying Process Optimization.
12 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
White paper
Increasing vial to vial homogeneity: an analysis of KRYOSEQ® nucleation on production scale freeze dryers.
13 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
11 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
10 min
Brands: IMA Life
White paper
FUSION™ & FUSION PLUS™
2 min
Brands: IMA Life, IMA S.p.A. – LIFE Division Bologna
Case study
Case study with Thermo Fisher Scientific
8 min
Brands: IMA Life
SENTINEL-LYO
In pharmaceutical manufacturing, even the most robust and reliable freeze dryers can benefit from advanced monitoring systems that detect latent anomalies and emerging issues before they escalate.
IMA SENTINEL-LYO, the AI-powered cloud platform developed by IMA, provides continuous insight into equipment performance, supporting smarter, data-driven decisions and long-term system reliability.
Key benefits of IMA SENTINEL-LYO for pharmaceutical freeze dryer monitoring:
• Predictive maintenance through AI-based anomaly detection
• Secure cloud connectivity for real-time machine-to-cloud data exchange
• Improved process visibility and traceability
• Enhanced decision-making through visual analytics and trend forecasting
KRYOSEQ® nucleation
An advanced innovative controlled nucleation technology capable of producing sterile cryogenic kryo fog and circulating it with a lyophiliser chamber to ensure reliable and prompt top-down nucleation of the vial-contained pharmaceutical formulations at an optimal temperature. KRYOSEQ® technology is applicable to IMA Life’s range of freeze dryers, such as LYPMAX, LYOFAST, MINIMAX, LYOFAST MINI and MINIFAST (KRYOSEQ LAB®).
CUMULUS®
An innovative cryogenic cooling technology using liquid nitrogen (LIN) as a cooling agent to overcome the performance and environmental limitations of mechanical systems.
KRYOSEQ LAB®
KRYOSEQ® nucleation for laboratories, KRYOSEQ LAB®, is a compact, portable system fitting in limited laboratory space equipped with an automated, user-friendly system with minimal user input required and with updated enclosure enabling improved internal access. All operations are conducted at or below atmospheric pressure and it is compatible with freeze dryers of various makes and models.
KRYOAIR
The search for a low environmental impact, high performance, safe, refrigeration system for freeze drying is now complete. The KRYOAIR air refrigeration system circulates ultra low-temperature air as the refrigerant. It is composed of three parts: an expander integrated with a compressor (compression and expansion), a primary cooler (heat dissipation) and a heat-recovery heat exchanger (heat recovery).
To better cope with peak heat demands, the KRYOAIR system combines a novel thermal energy storage system, along with the turbo compressor expander. The energy storage system has no moving parts, is compact, and environmentally friendly. The combination offers a high performance, efficient refrigeration system that has zero environmental impact caused by using refrigerants with a global warming potential.
FUSIONTM– FUSION PLUSTM
IMA Life’s patented FUSIONTM shelves are built in-house by a fully automated manufacturing process, ensuring higher quality and increased process reliability. They are designed and finished to improve the lyophilisation outcome and to reduce operating costs and energy consumption. The FUSIONTM shelves are lighter and more resistant than conventional solutions and offer enhanced heat transfer properties. FUSIONTM shelves are an integral part of the entire range of IMA Life freeze dryers.
QUANTUM
A smart miniature mass spectrometer, a non-invasive technique capable of performing quantitative real-time process-relevant measurements. A multipurpose device designed for use in pharma freeze-dryers, it detects contaminants and process gases at concentrations down to ppm levels.
Lyomax Series
Freeze-Drying
Lyofast Series
Freeze-Drying
Minimax Series
Freeze-Drying
Lyofast Mini Series
Freeze-Drying
Minifast Series
Freeze-Drying
Lab4Life Webinar Series
Lab4Life is IMA Life’s cutting-edge Lyophilizer Process Development Laboratory, where industry experts drive innovation and support customers in product development, scale-up and qualification.
During the series, we will observe how freeze-drying methods are evolving thanks to new approaches and technological innovations. IMA Life supports the pharmaceutical manufacturing industry with a broad range of equipment and solutions designed to enhance efficiency, increase the role of automation and focus on sustainability.
If you were unable to join the live session, you can now access our recently hosted webinars on demand, at your convenience. Stay informed on the latest topics and review expert insights whenever it suits your schedule.
Services
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 enhancementsTechnical 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.

Our technological team

Mehfouz Jalal
Research Scientist at IMALife North America
Mehfouz completed his B.S. in Chemical and Biomolecular Engineering from Georgia Tech and M.S. in Chemical Engineering from Purdue University. At IMA Life, Mehfouz is focusing on process development of vaccines and biologics along with scale-up/tech-transfer of processes between freeze dryers using heat and mass transfer modeling. In terms of emerging technologies, Mehfouz’s focus lies in developing continuous freeze-drying processes as an alternative to traditional batch freeze-drying. He was working as an Associate Research Engineer in the LyoHub Consortium for freeze-drying before accepting his current position at IMA Life.
Dennis Posheluk
Technical Product Manager and Associate Scientist at IMA Life North America
Dennis Posheluk is a Technical Product Manager/Associate Scientist at IMA Life North America Inc. Dennis completed his B.S. and M.S. in Mechanical Engineering at the University at Buffalo. His interests at IMA Life include fluid and heat transfer, mathematical modeling, and design optimization of spray freeze drying and lyophilization with controlled nucleation process.
Justin Griffiths
Research Scientist at IMA Life North America
Justin completed his B.S. in Chemistry at Niagara University and Ph.D. in Chemistry at University at Buffalo. His work at IMA Life includes pre- and post-lyophilization characterization, cycle development, process optimization, and scale-up/tech-transfer. In addition to these activities, his interests include the development of new heat transfer methods and the development of alternatives to traditional batch freeze drying.

Petr Kazarin
Research Scientist-Engineer at IMA Life North America
Holding a PhD in Aerospace Engineering, Petr has leveraged his rigorous academic background to become a distinguished researcher in vacuum freeze-drying/lyophilization for biopharmaceutical manufacturing. Specializing in heat transfer, multiphysics simulations, Computational Fluid Dynamics (CFD), and mathematical modeling, his expertise has led to significant advancements in lyophilization processes. During his time at LyoHUB, his innovative engineering solutions, developed in collaboration with industry partners, and his advanced experimental lab work, have contributed to the optimization of the lyophilization process. His lab experience is marked by meticulous experiment design, comprehensive data analysis, and effective troubleshooting.
Now at IMA Life, he directs initiatives in freeze-drying process optimization, excels in heat transfer modeling, and spearheads the development of innovative techniques such as spray-freeze-drying and microwave-assisted freeze-drying. His dedication to pushing the boundaries of freeze-drying technology goes hand in hand with his commitment to education and mentorship, solidifying his role as a pivotal figure in his field.
Dave Debo, PE
Senior Engineering Manager at IMA Life North America
Dave is the internal resource of experience for freeze drying products and equipment and lends his over two decades worth of experience in the field of pharmaceutical freeze drying. Dave completed his B.S. in Mechanical Engineering from Clarkson University and M.E. in Pharmaceutical Manufacturing from Stevens Institute. He is the principal point of contact for designing user requirement specification (URS) for IMA Life customers. Dave currently leads the engineering group for project engineering and supporting sales, existing product management and new product development.