Search Results for: FORMULATION DEVELOPMENT Overcoming Early Phase
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development March 4, 2019
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
SOFTGEL FORMULATIONS – Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market August 30, 2016
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
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.
FORMULATION DEVELOPMENT – Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies January 7, 2015
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
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, 2012Xcelience LLC recently announced the grand opening of a new 24,000-sq-ft facility, located south of the Tampa airport at 4901...
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.
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.
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.
SPECIAL FEATURE – Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation March 3, 2015
Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.
Archana Gangakhedkar, MS, and Jyothi Thundimadathil, PhD, indicate peptide-based linkers are promising counterparts in ADCs, providing tumor-specific cleavable and stable circulating linkers, and a new emerging class of PDCs is proving to be useful toward a broad spectrum of indications when compared to ADCs.
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.