The number of biopharmaceuticals being developed and manufactured has increased significantly in recent years. More than 10 novel biologics have been approved annually by FDA over the last three years, representing around 30% of the total novel drugs approved during this time period, according to Research and Markets.

The lyophilization equipment and services market is expected to register a CAGR of about 8.5% during the 2018 to 2023 time period. The lyophilization process, also known as freeze-drying, is used for preserving biological material by removing the water from the sample, which involves first freezing the sample and then drying it, under a vacuum, at very low temperatures.

Lyophilization is growing rapidly with the growth of biotechnology, but non-biotech products can also benefit. Lyophilized products in biotechnology and pharmaceuticals include injectable solutions, proteins, peptides, and vaccines. The number of such products has been growing steadily. It is expected that approximately 25% of biotechnology and pharmaceutical products will be lyophilized in the coming future.

For drug developers to set up in-house lyophilization capabilities and operations, which requires specialized equipment and expertise, is an expensive and time-consuming process. In order to decrease the overall cost of the product and yield cost savings, biopharmaceutical companies continue to outsource such operations to contract manufacturing organizations (CMOs). One such CMO that provides specialized facilities and dedicated lines for lyophilization operations is Jubilant HollisterStier Contract Manufacturing & Services.

From its Spokane, WA base of operations, the CMO offers sterile fill/finish of Phase I through commercial sterile injectable, as well as a full suite of lyophilization services. In fact, to keep up with the growing demand for its services, Jubilant is installing a new 385 square-foot lyophilizer at the Spokane site that is expected to come on-line during the third quarter of this year. Contract Pharma spoke with Jubilant’s president, Amit Arora, about the new lyo oven and what it means for the CMO in today’s market.

Contract Pharma: Why is Jubilant investing in a new lyophilizer?

Amit Arora: As part of Jubilant’s continued focus to support current and new business, Jubilant HollisterStier is increasing manufacturing capacity at its Spokane, Washington facility. The addition of the new lyophilizer will allow Jubilant more flexibility to service current and new customers as demand for lyophilization services increase over the coming years. Our new chamber is installed and is expected to begin commercial production during the third quarter of 2019.

CP: How does it expand Jubilant’s capabilities and capacity in the lyo space? In addition, can you provide some detail on the new oven’s specs?

AA: Jubilant HollisterStier’s Spokane, WA facility currently offers a clinical size 30 square-foot lyophilizer, two commercial 220 square-foot lyophilizers, and two 385 square-foot lyophilizers. The new 385 square-foot oven has enhanced optimizations such as an Automatic Loading/Unloading System (ALUS). The ALUS can reduce the potential for broken vials during loading, reducing waste and valuable lost product. In addition, the sight glass to view the chamber is adjusted to allow viewing during operation to quickly resolve any issues during the loading and unloading process.

CP:  Describe the advantages and disadvantages of lyophilization.

AA: The process of lyophilization allows drug product stability when liquid formulations cause degradation, chemical reactions, aggregation or biological growth. Lyophilization does not use heat, making it an ideal process for heat sensitive products. In addition, lyophilization reduces weight and volume of samples, which is ideal for shipping and can be stored at room temperature indefinitely. Lyophilized products do require the added step of including and administering a sterile diluent for reconstitution. Jubilant supports diluent production in addition to active drug product manufacturing.  

CP: As a CMO operating in the lyo space, what would you say are the biggest challenges offering lyo services in today’s (bio)pharma market?

AA:  Contract manufacturers always have to balance the cycles of filling and lyophilization. Jubilant is committed to supporting varying lyophilization cycle times and the new equipment helps Jubilant meet the scheduling demands of our client base. 

CP: How would you characterize the market today for lyophilized drugs? How does this compare to a few years ago and where do you see the market down the road?

AA: Jubilant continues to see growth in the need for lyophilized services as formulations become more complex and less stable in liquid form. We also see trends towards smaller batch sizes as drug companies focus on more narrow, segmented therapeutic areas. Jubilant will continue to invest in filling and lyophilization that support targeted indications as well as large volume products.