SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk March 30, 2016

Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.

EXECUTIVE INTERVIEW - Capsugel: Choosing the Right Pharmaceutical Design, Development & Manufacturing Partner January 7, 2016

SPECIAL FEATURE - Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015

Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.

PARENTERAL CONTAINERS - A Novel Approach to Mitigating Oxygen Permeation in Prefilled Syringes September 3, 2014

Peter Sagona, MS, Rómulo Romero, MS, and Adam Breeland report that biological systems are entering the market place at an increased rate, and thus focus on the importance of designing a primary container system (prefilled syringe) for the minimization of oxygen exposure to the drug product.

FORMULATION DESIGN - Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach May 7, 2014

Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.

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.

SPECIAL REPORT - Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money March 31, 2013

In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.

PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products September 29, 2023

Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.

2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry August 14, 2023

In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.

Preclinical Data Shows Strong Immunogenicity & Protection With IMUNON’s PlaCCine DNA-Based Vaccines Modality August 7, 2023

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.

2022 Analytical Testing eBook – Service Providers Offer Innovation August 23, 2022

Learn more about the technologies from Alcami, Associates of Cape Cod, Stevanato Group, and West in this exclusive 2022 Drug Development & Delivery Analytical Testing e-book.

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.

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.

ANALYTICAL SERVICES - Applying Innovative Thinking & Techniques to Reduce Time-to-Market May 4, 2020

Ramesh Jagadeesan, PhD, says that while CDMOs have the capacity to support pharmaceutical companies with their analytical requirements for both small and large-scale projects, the opportunity exists to increase speed to market with innovative thinking.

SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results January 14, 2020

Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.

White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications October 16, 2019

This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.

SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019

Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.

CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens August 27, 2018

Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.

ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products April 3, 2018

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.