Lyophilization Process Development

Freeze-drying is the preferred method for achieving stable drug products for many fragile (bio)drug substances. Freeze drying, also called "lyophilization", is mainly used to remove water from sensitive products (mainly biological products) without causing damage. As a result, the product can be preserved permanently and later restored to its original state by adding water. In order to develop a robust and economical lyophilization cycle suitable for large-scale production, CD Formulation's experts perform a comprehensive lyophilization process development service based on product requirements and customer needs.

Lyophilization Process Development Services

We have many years of experience in the development, optimization, scale-up and transfer of lyophilization cycles for (bio)pharmaceuticals. In our lyophilization development center, through the use of a variety of lyophilizers—from laboratory to production scale—and for the development of processes for many different pharmaceutical products, including:

We can work with a variety of different primary packaging formats, including vials, cartridges and bulk trays. CD Formulation has a large portfolio of process analytical technologies alongside the development of lyophilization processes, as well as additional analytical technologies to ensure the highest pharmaceutical quality. Pleasant feel free to learn more about our capabilities in lyophilization process development and get in touch with our experts.

Advantages of Lyophilization Technology

Type	Advantages
Enhance product quality	Provides lot-to-lot consistency, with all samples treated uniformly. Product is stable over a wide range of temperatures, so it can be used in all climates and conditions while maintaining sample integrity. Up to two years of room temperature stability with no measurable loss of activity. Supports field applications, including remote areas with inadequate infrastructure or inaccessible locations (e.g., developing countries), without compromising sample or data quality. Improved data quality and reliability of results through pre-assigned single-dose measurements, while also reducing the risk of contamination.
Streamline workflow and save costs	Fewer sample handling and pipetting steps are required, simplifying the end-user's workflow. Reduced training requirements as assays or samples are ready-to-use. Compatible with downstream applications and automation. Extends shelf life and reduces waste. Can be shipped without refrigeration, reducing shipping costs.
Reduced environmental impact	Freeze-dried samples are lighter and smaller, making them ideal for transport. No dry ice or ice packs are required for transport. Transport is less hazardous than wet reagents and does not require special permits.

How to Contact Us?

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

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Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.