SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise April 2, 2014

Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.

Xcelience Opens New Development Facility September 16, 2012

Bend Research & Xcelience Form Partnership to Speed Drug Product Intermediates to Early Phase Clinical Trials August 25, 2011

SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024

Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.

Ascendia Pharmaceuticals Expanding Injectable Manufacturing Capabilities in 2024 January 31, 2024

Ascendia Pharmaceuticals is all set to unveil its new injectables manufacturing opportunities with the launch of a state-of-the-art sterile cGMP production facility in March 2024…..

SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity October 2, 2023

Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.

SOLUBILITY ENHANCEMENT - How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery August 31, 2022

Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.

TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2 February 24, 2022

TFF Pharmaceuticals, Inc. recently announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the company’s inhaled niclosamide product candidate completely….

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.

PFS MANUFACTURING - Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery June 4, 2020

Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.

EXECUTIVE INTERVIEW - Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies March 31, 2020

Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.

SPECIAL FEATURE - Improving Bioavailability & Solubility: Understand Your Molecule March 3, 2020

Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.

ON-TARGET DELIVERY - Lipid-Based System Introduces a Novel Approach for an HIV Vaccination August 29, 2019

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.

PEPTIDE DELIVERY - The Endometriosis Enigma – Why Can't There Be a Pill for That? June 4, 2018

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.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability May 31, 2018

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.

SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients April 2, 2018

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.

AAV VECTOR MANUFACTURING - Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments February 28, 2017

Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.

SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges May 2, 2016

Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.

PULMONARY DELIVERY - Afrezza – Another Lesson for Drug Delivery Professionals? February 29, 2016

Josef Bossart, PhD, believes Mannkind’s recent announcement that Sanofi has decided to return the marketing rights for Afrezza may not exactly be history repeating itself, but it certainly feels as though it rhymes.

SINGLE-USE MARKET - Rise of Single-Use Technologies & Systems in Biopharmaceuticals November 19, 2015

Kevin James and Shalini S. Dewan of BCC Research believe eliminating the risk of contamination is the greatest challenge faced by manufacturers of biopharmaceuticals, and currently, this requires high-level monitoring of critical manufacturing processes. Single-use technology aids biopharmaceutical manufacturers in overcoming this challenge by reducing or eliminating the need for sterilization between batches, thereby improving operational efficiency.