SCHOTT Pharma, a pioneer in drug containment solutions and delivery systems, has announced the development of cartriQ® BioPure, a new sterile glass cartridge. Featuring enhanced chemical resistance and an improved extractables and leachables profile, it is designed to meet the demanding requirements of modern biotech medicines.
“As therapies become increasingly complex and sensitive, we are investing in high-quality primary packaging that safeguards drug stability, supports comfortable administration, and scales with our customers’ pipelines,” says Andreas Reisse, CEO of SCHOTT Pharma. “The optimised cartridge expands our high‑value solutions portfolio for biological drugs and empowers pharmaceutical companies to select the right container – vial, syringe, or cartridge – based on the specific molecules' needs and lifecycle of each therapy.”
New high-performance glass cartridge protects sensitive biologics across their shelf life. Image: SCHOTT Pharma
Engineered for complex biologics such as monoclonal antibodies, fusion proteins, and other sensitive molecules, as well as fertility treatments and therapies for growth hormone deficiencies, cartriQ® BioPure addresses key challenges for pharmaceutical companies. These include long‑term drug stability with reduced risk of leachable effects, low levels of free silicone, and compatibility with drug-delivery devices that enable safe and reliable administration. By complementing EVERIC® pure vials and syriQ BioPure® glass syringes, the advanced glass cartridge provides pharmaceutical companies with a comprehensive container choice from early development through commercial supply.
A new benchmark for sensitive biologics
cartriQ® BioPure combines SCHOTT Pharma’s long-standing materials expertise with targeted process innovations to deliver a high-performance glass cartridge platform for sensitive biologics. It is manufactured from enhanced FIOLAX® Pro glass tubing, offering exceptional chemical quality and an improved extractables and leachables profile. By applying strict release criteria for sodium and aluminium, the cartridge performs significantly below ISO maximum limits for hydrolytic resistance and goes beyond evolving regulatory expectations, including the current USP <660> draft. This level of control supports robust stability profiles for sensitive biologics, both today and in the future.
To further minimise drug–container interaction, the sterile glass cartridge employs baked‑on silicone technology, achieving low and well-controlled silicone levels that are verified through rigorous release testing. Coated elastomers used for plunger stoppers and combi-seals, along with improved surface durability and optimised residual seal force, collectively preserve drug integrity from fill‑and-finish through to patient delivery. Tight body tolerances enable accurate dosing – an essential requirement for therapies with narrow therapeutic windows – while enhanced mechanical strength significantly reduces breakage risk during handling and administration steps.
cartriQ® BioPure will be available in 3 ml and 5 ml for use with pens and autoinjectors to facilitate self-administration. While the commercial launch is planned for the end of the year at CPHI Milan 2026, samples of this glass cartridge are already available.
