INJECTABLE DRUG DELIVERY ARTICLES
Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
INJECTABLE DRUG DELIVERY RESOURCES
-
When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.
-
Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
-
Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs and what it takes to stay compliant.
-
This technology addresses workforce shortages and growing medical complexity by helping healthcare providers manage rising demands, improve efficiency, reduce errors, and extend care access.
-
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
-
By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.
-
Here, we discuss the differences between nanoparticles and liposomes along with their applications in medicine.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
-
Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.
-
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
-
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
-
Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
-
Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
-
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.
-
More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.
-
Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.
-
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.