Interpace Diagnostics Announces US Patent Approval: MicroRNAs as Biomarkers for Distinguishing Benign From Malignant Thyroid Neoplasms October 21, 2021

DEVICE DEVELOPMENT - Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk October 4, 2021

Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

DRUG DEVELOPMENT - Simplifying the Drug Development Journey October 4, 2021

Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.

SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021

Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.

HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution August 26, 2021

Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.

Entasis Therapeutics & Zai Lab Complete Patient Enrollment in the ATTACK Phase 3 Registrational Clinical Trial July 28, 2021

2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021

In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021

Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.

FORMULATION FORUM - Nanosuspension Dosage Forms: Product Development & Scale Up June 2, 2021

In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.

SPECIAL FEATURE - PFS & Parenteral Manufacturing: How COVID-19 Changed the Market May 3, 2021

Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.

BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices March 29, 2021

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

SPECIAL FEATURE - Improving Bioavailability & Solubility: Each Molecule Is Unique March 1, 2021

Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.

SPECIAL FEATURE - Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis January 14, 2021

Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.

BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications January 13, 2021

Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.

Nemera to Acquire Copernicus to Boost Parenteral Product Portfolio & Small Series Capabilities October 29, 2020

Nemera recently announced it has entered into an agreement to acquire Copernicus, which specializes in the development and manufacturing of injection devices…

Scientific Management of Pharmaceutical Container Closure & Delivery Device Compatibility October 13, 2020

Diane Paskiet says the relationship between pharmaceutical products and CC/DD is best managed through a rich science-based approach that factors in potential risk and is adapted early in the development process.

SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market? September 1, 2020

Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.

2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases June 30, 2020

This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.

Nemera & Noble Announce Collaboration to Support Patients Who Self-Administer Medication June 17, 2020

Nemera, world leader in design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries, recently announced a collaboration with Noble….

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions May 5, 2020

Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.

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