ON-BODY DELIVERY SYSTEMS - Analysis & Simulation of Injection Volume Accuracy
Christian Riva, MS, presents a case study proving it is possible to have a realistic prediction of the injection volume accuracy of a drug delivery system, even in an early stage of product development, when only a high-level product architecture is available.
EXECUTIVE INTERVIEW - Cambrex: Providing Big Value in the Small Molecule Outsourcing Market
Simon Edwards, President, CDMO Sales & Marketing at Cambrex, discusses the biggest trends in the small molecule outsourcing market.
PACKAGING SOLUTIONS - Dura Coat Combiseals - An Optimal Solution for Cartridge Applications
Carina Van Eester, MSCE, believes with state-of-the-art medicines, it is essential that drug manufacturers can rely on appropriate sealing solutions that provide the best possible protection for their products.
WEARABLE DEVICES - Wearable Drug Delivery Applications: Considerations for Adhesive Material Selection & Wear Testing
Neal Carty, PhD, MBA, and Deepak Prakash, MS, MBA, discuss the broader healthcare and digital health landscape behind wearable device developments and provide a brief overview of two types of wearable applications — insulin pump therapy/continuous glucose monitoring (CGM) systems and wearable drug injectors.
DATA ANALYTICS - Leveraging Cloud-Based Data & Analytics to Optimize Pharmaceutical Manufacturing
Benzi Mathew explains how recognition is increasing about the powerful impact data and analytics can have on optimizing the manufacturing process and ensuring demand is met every time, all the time.
SPECIAL FEATURE - Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration
Contributor Cindy H. Dubin highlights the innovation in injection devices – from wearables to connectivity to varied dose administration – that have occurred in the past year.
DEVICE DESIGN - Autoinjector Design Adjustment to Control Needle Insertion & Initial Injection Speed – Could This Positively Impact Drug Delivery?
Pascal Dugand, Thomas Megard, and Séverine Duband explain how controlling the needle insertion speed can reduce the shock on the prefilled syringe, which can reduce the risk of glass breakage, and will allow a smooth transition to syringe emptying.
BIOLOGICS DELIVERY - Enabling Biologic Drug Delivery of Volumes Beyond 1 mL
Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.
INTRATUMORAL DELIVERY - Arming the Immune System; Turning Cold Tumors Hot
Daniel J. O’Connor believes a trigger mechanism that can turn cold tumors hot can help researchers set their focus on delivering potentially life-saving drugs directly to core of a cancerous tumor.
ON-TARGET DELIVERY - Lipid-Based System Introduces a Novel Approach for an HIV Vaccination
Fabrice Navarro, PhD, summarizes recent disappointing clinical trial results for HIV vaccines and reports on CEA-Leti’s new approach based on engineered lipid nanoparticles that deliver p24 (a viral protein that optimizes the CpG adjuvant’s effect) with pinpoint accuracy.
THERANOSTICS - The Outlook for the Theranostic Radionuclide Approach to Neuroendocrine Tumors & Other Cancers
Eric P. Krenning, MD, PhD, and Rachel Levine provide a review of the evolution and development of theranostics, in general, citing the theranostic radionuclide approach to the management of neuroendocrine tumors to highlight this evolving modality.
EXECUTIVE INTERVIEW - Eloxx Pharmaceuticals: Developing Rare Disease Drugs for Nonsense Mutations
Bob Ward, Chairman and CEO at Eloxx Pharmaceuticals, discusses nonsense mutations and how his company’s goal is to bring safe and effective therapies to children and adults suffering from genetic diseases as quickly as possible.
2019 Respiratory Drug Development eBook - Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
PARENTERAL DEVELOPMENT - Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
DEVICE DESIGN - Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
IN VITRO DDI STUDIES - 2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
Brian Ogilvie, PhD, and Andrea Wolff explain the implications of the new timing requirements and best practices for negotiating them efficiently and effectively moving forward.
BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
MARKET BRIEF - Nothing Degrading About Saving Lives: E3 Ligands Recruiting New Drugs Into the Clinic
Marianna Tcherpakov, PhD, discusses underexploited strategies, traditional approaches that can be optimized, novel techniques beginning to emerge and pay dividends, and results propelling this field toward better clinical outcomes.
FORMULATION FORUM - Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development
Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.
