Formulation Development
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.
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.
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.
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.
EXCLUSIVE ONLINE CONTENT
Appili Therapeutics Enters Commercial Agreement With Saptalis Pharmaceuticals
Appili Therapeutics Inc. recently announced it has entered into a commercialization agreement with Saptalis Pharmaceuticals LLC on ATI-1501, Appili’s liquid suspension reformulation of the…..
Biogen Announces Positive Phase 2 Study Results
Biogen Inc. recently announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized….
OWP Pharmaceuticals Announces Second IND Approval & Patent Application for First-Ever Liquid Oral Suspension Formulation
OWP Pharmaceuticals, Inc. recently announced today that it has received Investigational New Drug (IND) approval from the US FDA, and has submitted for US patent protection, for the first-ever liquid formulation of….
PPD Expands Special Patient Capabilities in Early Development Research
PPD, Inc. has expanded its early development research services by adding significant neuroscience and ethno-bridging expertise, broadening its capabilities to provide increased access to…..
Recipharm Announces Commercial Manufacturing to Support Drug Launch Following FDA Approval
Recipharm, the contract development and manufacturing organisation (CDMO), recently announced ongoing large-scale commercial manufacturing of RedHill Biopharma’s drug, Talicia (omeprazole magnesium,…..