Formulation Development
PEPTIDE DELIVERY – The Endometriosis Enigma – Why Can’t There Be a Pill for That?
Joel Tune, MBA, says for those peptide therapeutics that meet the necessary criteria, advances in formulation technologies coupled with favorable market dynamics will continue to drive interest across the entire prescription drug spectrum for safe and effective orally administered peptide therapeutics.
MICROFLUIDICS – Taking a Microfluidics Approach to Drug Delivery
Richard Gray, MA, and Pavel Abdulkin, PhD, look at how microfluidics is changing the drug development sector and explore an exciting new non-encapsulating microparticle-based approach that offers “tunable” release of the API.
PERSONALIZED IMMUNOTHERAPY – Off-the-Shelf Personalized Immunotherapy for Breast Cancer: The BriaCell Solution
William V. Williams, MD, Markus Lacher, PhD, and Charles L. Wiseman, MD, explain how there is a clear need for ways to stimulate effective cancer-specific immune responses while avoiding time-consuming and costly individualized manufacturing.
THERAPEUTIC FOCUS – Antisense Drug Shown to Significantly Reduce Triglyceride Levels in Patients With Severe Hypertriglyceridemia
Ioanna Gouni-Berthold, MD, provides results from a clinical study indicating antisense technology can result in significant reductions in triglyceride levels in patients with hypertriglyceridemia.
MULTIPARTICULATE SYSTEM – Advances in Lipid Multiparticulate Technologies for Controlled Release
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
EXECUTIVE INTERVIEW – Singota Solutions: Keeping Up With Trends & Technology as a CDMO
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
GLOBAL REPORT – 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017
In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.
SOLID FORM SCREENING – Phase Appropriate Strategies for Solid Form Discovery & Development
Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.
INTEGRATED DELIVERY SYSTEMS – The Value of an Integrated System for Combination Products
Theresa Bankston, PhD, says the fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with increasing complexity of longer-acting formulations, larger injection volumes, and longer injection durations, has raised the bar for seamless injection delivery technology.
EXCLUSIVE ONLINE CONTENT
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Clinical Services Announces Site Expansion to Support Growth & Flexibility
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement
Organovo Holdings, Inc. recently announced it has entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine (IIAM).
Verona Pharma Completes Enrollment in Phase 2 Clinical Trial
Verona Pharma plc recently announced it has enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic/long-acting beta2-agonists (LAMA/LABA) and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe COPD.
Sanofi & Denali Therapeutics to Develop Multiple Molecules; $125 Million Upfront
Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.