Featured Articles
CLINICAL TRIALS - Maximizing Immuno-Oncology Clinical Trial Success
Luke S. Gill, MSc, MBA, believes understanding and overcoming various challenges in the development of immunotherapeutic agents will be critical to clinical trial success and, ultimately, market approval.
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.
CONTAINER CLOSURE SYSTEM - Recent Prefillable Syringe Developments Mirroring Increasing Biotech Drug Product Demands
Stefan Verheyden says the container closure system has become a decisive factor for sustained market success, with autoinjectors and injection pumps as growing areas of interest.
INJECTABLE NANOMEDICINES - New Developments in Long-Acting Injectable Nanoformulations
Dongwei Guo, PhD, and Jingjun Huang, PhD, focus on the overview of nanoproducts in the market and the technologies to make long-acting injectable nanoformulations.
THROAT SPRAY SYSTEMS - Key Considerations When Developing a Throat Spray Solution
Degenhard Marx, PhD, and Günter Nadler discuss the treatment of sore throats via a pump spray and explore the considerations to be made when developing a reliable spray product.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 2, Notable Product Approvals of 2017
In part 2 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews the more interesting individual products approved throughout the past year.
PREFILLED SYRINGES - Prefilled Syringe Automated Inspection & End-Product Testing
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients
Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.
EXECUTIVE INTERVIEW - MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
EPR SPECTROSCOPY - Bringing EPR to a Wider World: Biological ROS & RNS Detection
Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.
EXECUTIVE INTERVIEW - NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
GAS-POWERED DELIVERY - Innovating Injectable Devices to Deliver Today’s Pharmaceuticals
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
SCALE-UP & MANUFACTURING - Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE - Improving Bioavailability & Solubility: A Top-Down Versus Bottom-Up Approach
Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.
