INJECTABLE DRUG DELIVERY ARTICLES

DNA-Neurological Research-GettyImages-1224202684 Formulation And Delivery Considerations For Cell And Gene Therapies

How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.

INJECTABLE DRUG DELIVERY VIDEOS

Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

INJECTABLE DRUG DELIVERY RESOURCES

INJECTABLE DRUG DELIVERY SOLUTIONS

  • As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.

  • Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

  • As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

  • As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.

  • A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.

  • BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.

  • Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,

  • We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.

  • Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.

  • From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.