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Hyaluronan-Based Hydrogels as Functional Vectors for Standardised Therapeutics in Tissue Engineering and Regenerative Medicine
Published in Harishkumar Madhyastha, Durgesh Nandini Chauhan, Nanopharmaceuticals in Regenerative Medicine, 2022
Alexandre Porcello, Alexis Laurent, Nathalie Hirt-Burri, Philippe Abdel-Sayed, Anthony de Buys Roessingh, Wassim Raffoul, Olivier Jordan, Eric Allémann, Lee Ann Applegate
Notwithstanding the considerations exposed hereabove and set forth for hyaluronan-based hydrogel development, which mainly revolves around the field of medical devices, additional parameters need to be taken into account for the sound development of biological combination products (e.g. cATMPs) for effective and safe delivery of therapeutic cellular materials. Such combination products are of high interest and have the potential to meet clinical needs, as they may act by exerting intrinsic additive or synergistic effects. Specific parameters and dimensions of combination product design and development are presented hereafter.
Microneedles for Drug Delivery
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
Lisa A. Dick, Daniel M. Dohmeier, Ann M. Purrington, Scott A. Burton
Data packages need to be established for all disciplines utilized in the development of microneedle products, within the framework of an appropriate quality system for these drug–device combination products. Combination product development and data package preparation requires careful consideration of the elements of each part of the product on its own and also the crucial interactions. A product’s registration status may vary based upon region of the world, but the intent is the same, to deliver a drug or biologic with the assistance of a delivery system.
Biologic Drug Substance and Drug Product Manufacture
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Ajit S. Narang, Mary E. Krause, Shelly Pizarro, Joon Chong Yee
Many parenteral protein therapeutics are used in life threatening and serious medical conditions, which often require more than one therapeutic agent. The parenteral administration of multiple therapeutic agents can seriously impact the quality of life of the patient, as extended chair time and/or multiple trips to the clinic may be required. Combination products that include, for example, two synergistic large molecules or one large and one small molecule in the same injection can have significant advantage over two separate injections or the need for infusion for drug delivery. However, in some cases, a combination product can increase the risk of physical and chemical instability of both the drugs.
A multicenter, open-label, phase 3 study to evaluate the safety of fremanezumab for migraine, subcutaneously self-administered with an auto-injection device at institutional sites and at home
Published in Expert Opinion on Drug Safety, 2023
Koichi Hirata, Takao Takeshima, Noboru Imai, Hisaka Igarashi, Masako Shiosakai, Masanobu Inage, Fumi Sakurai, Xiaoping Ning, Masami Nakai, Nobuyuki Koga
In the present study, Japanese patients with migraine self-injected fremanezumab 225 mg at their institutional site and at home using an AI device. All patients successfully and safely handled the AI device for fremanezumab injection according to the AI Manual. Following self-injection at either location, no clinical issues were found in the safety profile of AI-assisted fremanezumab injection. Migraine days and headache days of at least moderate severity were decreased from baseline. Overall, the results of the present study indicate good tolerability of the combination product. Thus, it is practically feasible for migraine patients to perform AI-assisted self-injection of the drug at home. Enabling patients to perform self-injection will be clinically significant in view of improved utility of and adherence to the drug product [24].
The road to market implantable drug delivery systems: a review on US FDA’s regulatory framework and quality control requirements
Published in Pharmaceutical Development and Technology, 2018
Sana Al-Jawadi, Pier Capasso, Manisha Sharma
Accordingly, the need for clearer identification and affirmation of the developmental route required for a new implantable drug delivery system are some of the key aspects for future improvement of the regulatory framework currently in place for such products (Amor 2015). Though the FDA does offer and encourage early consultation to assist in providing early class determination for products in development, as well as offering guidance in setting developmental milestones to assist in designing and developing the appropriate studies for ascertaining safety and efficacy, few guidance procedures are only available (FDA 2016c). Furthermore, the complexities of addressing issues for the product as a whole presents additional challenges to developers, particularly if the either components are new or unregulated (FDA 2016c, 2017c). The cost and resources involved in developing a component in addition to the whole combination product may be excessive. This unfortunately creates an infrastructure that greatly encourages combining regulated components as the system does not provide clear guidance to develop a combination product and one of its constituents simultaneously. Another frontier for FDA thus lies with developing clearer guidance for combination products that include a novel constituent (O'Shea 2014).
Insights into human factor studies conducted for US FDA-approved biological combination products
Published in Expert Opinion on Drug Delivery, 2019
Ronak Patel, Miten Mehta, Parag Pipalava, Meghana Dahiya, Inderjeet Singh, Vinu Jose
Recent advances in technology have led to increasing number of products being developed as a combination product (drug and device, biological product, and device). For patients with chronic diseases, combination products offer several advantages, such as self-injection, improved patient convenience and compliance, and lowering healthcare cost associated with physician’s visits and administration charges. At present, pre-filled syringe (PFS), pre-filled pen, and autoinjector are the most commonly available devices for several drug products, especially biological products [1–3].