{"id":162,"date":"2026-05-10T12:49:14","date_gmt":"2026-05-10T12:49:14","guid":{"rendered":"http:\/\/dali.imagidev.com\/?post_type=success_story&p=162"},"modified":"2026-05-10T12:49:14","modified_gmt":"2026-05-10T12:49:14","slug":"commercialization-of-a-sasytm-safety-syringe-for-a-highly-viscous-lanreotide-injection","status":"publish","type":"success_story","link":"https:\/\/dali.imagidev.com\/index.php\/success_story\/commercialization-of-a-sasytm-safety-syringe-for-a-highly-viscous-lanreotide-injection\/","title":{"rendered":"Commercialization of a SASYTM Safety Syringe for a Highly Viscous Lanreotide Injection"},"content":{"rendered":"\n

Project Overview<\/strong><\/strong><\/p>\n\n\n\n

Element<\/td>Details<\/td><\/tr><\/thead>
Pharma Partner<\/td>Large Indian pharmaceutical company developing a Lanreotide drug.<\/td><\/tr>
Drug<\/td>Lanreotide (originator brand: Somatuline\u00ae Autogel\/Depot) \u2013 long\u2011acting somatostatin analogue used for acromegaly and GEP\u2011NETs.<\/td><\/tr>
Therapy profile<\/td>Highly viscous, gel\u2011like depot formulation administered via deep\u2011subcutaneous (deep\u2011SC) injection over ~20 seconds using an 18G \u00d7 20 mm needle.<\/td><\/tr>
Key challenges<\/td>Developing a passive safety syringe for a highly viscous deep\u2011SC Lanreotide injection that delivers the same usability as the Lanreotide Reference Listed Drug (RLD), while adapting the device to the drug\u2019s viscosity and injection profile, providing post\u2011injection sharps protection, and doing so without infringing active patents around the originator delivery system.<\/td><\/tr>
Starting point<\/td>SASY-G1 passive safety device for 1 mL ISO glass prefilled syringes (PFS) with staked needles, preserving standard PFS usability while adding passive safety.<\/td><\/tr>
Solution<\/td>Customization of SASY-G1 \u2013 syringe type, needle, connection interface and device design \u2013 to fit the specific characteristics of the Lanreotide formulation and its safety\u2011syringe delivery requirements, including meeting the relevant requirements with the RLD (Reference Listed Drug)<\/td><\/tr>
Regulatory & launch<\/td>Approved in the U.S. in 2024 via an ANDA 505(b)(j) pathway as part of a Lanreotide drug\u2013device combination product; commercial supply started, with launches in additional markets planned next.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Project Introduction<\/strong><\/p>\n\n\n\n

A big Indian pharmaceutical company required a safety syringe solution for its Lanreotide drug product. The company sought a delivery system that could support a highly viscous deep\u2011SC injection, provide a passive safety mechanism, minimize dead volume, and offer an equivalent solution compared to the Lanreotide RLD (Reference Listed Drug), such as the same usability, etc., already used in the market. At the same time, the device needed to be designed in a way that does not infringe active patents around the originator delivery system.<\/p>\n\n\n\n

DALIMED customized its SASY platform for this program, adapting the device to the specific characteristics of the Lanreotide formulation and to the requirements of a passive safety syringe for this therapy.<\/p>\n\n\n\n

The Drug and Market Context<\/strong><\/p>\n\n\n\n

Lanreotide (the active ingredient in Somatuline\u00ae) is a long\u2011acting somatostatin analogue used to treat acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP\u2011NETs). It is administered via deep\u2011subcutaneous (deep\u2011SC) injection monthly in several dose strengths.<\/p>\n\n\n\n

The formulation is a highly viscous, gel\u2011like depot. It requires a slow manual injection of an 18G \u00d7 20 mm needle, creating a demanding set of constraints for a safety syringe solution. The combination of high viscosity and deep\u2011SC route determines essential requirements for the device.<\/p>\n\n\n\n

SASY-G1 as the Base Product<\/strong><\/p>\n\n\n\n

SASY-G1 is a passive safety device for 1 mL ISO glass prefilled syringes with staked needles. It is designed to maintain the familiar usability of a standard prefilled syringe, with no change to injection technique; the plunger is pressed in the same way. At the end of injection, the syringe automatically retracts into the device and the needle is covered and locked for sharps protection.<\/p>\n\n\n\n

For the Lanreotide program, these characteristics made SASY-G1 a suitable base. The platform already supported complete dose delivery and passive sharps protection, and it could be customized in terms of syringe & needle configuration, ergonomics, and injection performance.<\/p>\n\n\n\n

Engineering Changes<\/strong><\/p>\n\n\n\n

To meet the demands of Lanreotide, DALIMED implemented a focused set of engineering modifications:<\/p>\n\n\n\n

    \n
  • Syringe change<\/strong>
    The delivery configuration was adapted from a glass prefilled syringe with a staked needle to a polymer syringe with an appropriate connection for the 18G \u00d7 20 mm needle used for deep\u2011SC Lanreotide injection.<\/li>\n\n\n\n
  • Device design changes to fit the needle<\/strong>
    The SASY-G1 device was modified in length and size, and its external & internal components were adjusted to accommodate the polymer syringe and the large\u2011gauge needle. Despite the increased size, the goal was to keep the device ergonomic and user\u2011friendly, preserving SASY-G1\u2019s intuitive handling, complete dose delivery, and reliable passive safety mechanism after injection.<\/li>\n<\/ul>\n\n\n\n

    Regulatory Pathway and Production Readiness<\/strong><\/p>\n\n\n\n

    Because an injectable Lanreotide product was already available on the market, the generic program followed an ANDA 505(b)(j) pathway in the United States, with this customized safety syringe included as part of the drug\u2013device combination product. DALIMED supported the partner by providing the device\u2011related documentation required for the submission, including development information, verification data and safety\u2011related materials.<\/p>\n\n\n\n

    In parallel, DALIMED prepared the customized SASY-G1 configuration for commercial manufacture, developing the molds and tooling and setting up the production line so that the device would be ready for supply at commercial scale.<\/p>\n\n\n\n

    Outcome<\/strong><\/p>\n\n\n\n

    The customized SASY-G1 safety syringe for Lanreotide was approved by the FDA in the United States during 2024 via an ANDA 505(b)(j) pathway as part of a drug\u2013device combination product and entered commercial supply. Launch in European additional markets is planned to follow.<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-162","success_story","type-success_story","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/success_story\/162","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/success_story"}],"about":[{"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/types\/success_story"}],"version-history":[{"count":1,"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/success_story\/162\/revisions"}],"predecessor-version":[{"id":163,"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/success_story\/162\/revisions\/163"}],"wp:attachment":[{"href":"https:\/\/dali.imagidev.com\/index.php\/wp-json\/wp\/v2\/media?parent=162"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}