FAQ

Do you have experience lyophilizing my type of product?

We have worked with a spectrum of products. While most are for parenteral use, we are not limited to parenterals. We have worked with the following:

Do you have experience lyophilizing in other container types (vial, syringes, packs, etc.)?

Yes, we have extensive experience and in fact it is the "out of the norm" container/closure configurations that really intrigue us. We can and have adapted to vials, syringes, cartridges, and other unique configurations.

Can you handle projects requiring containment?

Lyophilization Technology, Inc. is uniquely equipped to handle highly potent toxic and potentially biohazardous materials. From product characterization and cycle design to scale-up and clinical trial material preparation, we can safely and effectively meet your containment needs. Each product undergoes a safety review. We have experience with a spectrum of materials requiring containment including but not limited to blood product, vaccines including attenuated, vector and recombinant vaccines, hormones, cytotoxics, and steroids.

What services do you provide for pre-filled syringes and cartridges?

LTI offers product and process development services for PFS and cartridges as well as clinical trial material processing. LTI would be willing to assist in container/closure selection, procurement, and process development. LTI has the capability to process various cartridge sizes and plunger orientations.

Do you make commercial product?

No we do not. We specialize in helping clients with their needs from right out of Drug Discovery through Clinical Phase II. Once in Phase III and making your submission batches, it is best to be at the site where you will produce your commercial product. We do have great relationships with commercial suppliers and aid in the technical transfer to make the process quick and efficient.

Does it take 6 months or longer to get in your queue?

Not at all. We enjoy a reputation for being very flexible and meeting clients' often tight deadlines.

How long will it take to complete a project?

A great question whose answer really depends on the project and the starting point. We would suggest we take our discussions to the next level and talk project specifics to gain a feel for a timeline.

Do I really need to perform Low Temperature Thermal Analysis (LT-TA)?

Yes! The agency is knowledgeable in lyophilization and is expecting to see this information detailed within a submission. LT-TA is the foundation for developing a robust transferable and scalable lyophilization process.

Are all of your services handled in-house? If not, what would be outsourced?

We perform testing specific for a lyophilized product. These include, FDM, HT-DSC, LT-DSC, KF, pH, Recon, Osmolality, etc. in house. Analytical assays, pXRD, SEM, etc. are outsourced to one of the many labs we have arrangements with.

Can I get customized lyophilization training at my site?

Absolutely. This is requested often by clients who want training to supplement their in-house expertise.

Do you sell lyophilizers or other equipment? Can you provide recommendations?

We cover all aspects of lyophilization with the exception of selling and servicing equipment. However, based on your needs we could provide recommendations.

Do you have commercial manufacturers lined up or willing to work with you if we decided to go commercial with the product(s) we develop at LTI?

We do have great relationships with commercial suppliers and aid in the technical transfer to make the process quick and efficient.

Is this Ed Trappler's company?

Yes, Ed Trappler is the president of the company and he has several knowledgeable and efficient company representatives in place to aid him in customer service and project management.

What is your logo? Is it meant to be half a snowflake?

It was designed by Ed himself and represents the phases of the solvent during lyophilization. The left half represents the liquid phase. The bottom right half, the frozen solvent and the top right, the lyophilized material. We are not only the experts in lyophilization but we are true scientists at heart who love the science behind water, ice, and sublimation. For some interesting facts about snowflakes and amazing pictures please visit www.snowcrystals.com.