INJECTABLE DRUG DELIVERY ARTICLES
Part 4 cGMP Summaries For Combination Products: Uncovering FDA Expectations
In this article, consultant Doug Mead reports on precedent research he conducted into FDA databases on 21 CFR Subpart cGMPs for combination products. His observations and conclusions offer sound advice on how to approach summaries submitted for BLA and NDA purposes.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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
-
![combination]( "Combination Products: Market Trends And Regulatory Considerations")
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
-
![Syringes GettyImages-171324030]( "Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation")
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
-
![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
-
![Simplify the journey]( "Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs")
Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.
-
![Vaccine Vial GettyImages-1216812369]( "Inspection Of Injectable Products For Visible Particulates")
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
-
![BD1]( "Characterizing Injection Factors And Their Impact On System Function")
The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.
-
![West-DELIV 3 - GC_App_PFS Components (2)]( "How To Simplify Your Move From A Vial To A Prefilled Syringe")
Explore market trends that could impact the lifecycle strategies for your drug product and its packaging. Careful selection of drug packaging can save time and support a successful transition to new formats.
INJECTABLE DRUG DELIVERY SOLUTIONS
-
![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
-
![GettyImages-1171312168-lab-development-research]( "A CDMO With Oral Solid Dose And Sterile Injectable Expertise")
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
-
![cmo-cdmo-drug-discovery-GettyImages-184944030 (1)]( "Meet The Demands Of Today To Help Ensure The Possibility Of Tomorrow")
Emergency‑readiness programs strengthen response with dependable countermeasures, rapid‑action tools, and decades of expertise supporting teams facing chemical, biological, and other high‑risk threats.
-
![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
-
![West_GC_App_PFS 1 mL 1_3mL Plungers 003 WestPharm_2_1ml_1-3ml_Plungers LR]( "Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success")
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
-
![LSC 09.26 Newsletter Ypsomed Fig 1]( "Connected Solutions For Self-Injection")
From enabling connected clinical trials to supporting digital therapy management, our solutions help improve clinical trial operational efficiency and data quality, strengthen commercial success, and empower patients to self-manage their therapy.
-
![GettyImages-1133603364-lab-equipment-microscope-beaker-test tube]( "Formulations For Poorly Soluble And Low Bioavailability Drugs")
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.
-
![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
-
![BIMI]( "Aseptic Filling System For Pharmaceuticals: BI-MI")
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.
-
![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
