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FORMULATION FORUM – PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery June 5, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.
SPECIAL FEATURE – Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023
Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.
EXECUTIVE INTERVIEW – PCI Pharma Services: The Global, Integrated CDMO Partner of Choice April 3, 2023
John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses what it means to be the partner of choice in a very dynamic industry.
MARKET TRENDS – The Year of Resilience & Flexibility: Six Smart Ways CDMOs Are Preparing for 2023 April 3, 2023
Carsten Press says with biopharma businesses weathering one unexpected shift after another, it’s no surprise these organizations are looking to their partner networks for one thing above all: the flexibility they need to maximize their own business resilience.
FORMULATION FORUM – Changing the Landscape of Nanoparticles for Long-Acting Injectable Drugs March 1, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, say recently, there has been continued interest in parenteral NPs with sustained-release characteristics as more drugs discovered are poorly soluble and less bioavailable, and these challenges have led to enormous opportunities and launch of many drug products to market.
AUTOMATED SOLUTIONS – Automation & Shared Knowledge Pave the Way Into the Future March 1, 2023
Luca Valeggia says by no means is automation a novel concept for most research labs, but its swift advancement and expansion into new fields such as synthetic biology have shown us that we are only witnessing the start of what is possible.
Gerresheimer Presents its New Clinical Trial Kit to Accelerate Drug Development February 1, 2023
Gerresheimer presents its new Clinical Trial Kit at Pharmapack in Paris. This kit consists of sterile Gx RTF vials in...SPECIAL FEATURE – Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
FORMULATION FORUM – Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations October 10, 2022
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
2022 Respiratory Drug Development eBook – Demand Accelerates Devices July 8, 2022
This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.
SPECIAL FEATURE – Solubility & Bioavailability: Utilizing Enabling Technologies March 1, 2022
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
Sever Pharma Solutions Acquires Foster Delivery Science November 17, 2021
Sever Pharma Solutions (SPS) recently announced it has entered into a definitive agreement to acquire the assets of Foster Delivery Science (FDS) located in Putnam, CT…..
DRUG DELIVERY – CAPRO(TM): A New Advance in Polymeric Drug Delivery October 4, 2021
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
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.
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.
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.
OSD FORMULATIONS – Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
IMMUNOGENICITY TESTING – Regulatory Updates for Immunogenicity Assessment of Therapeutic Proteins September 30, 2020
Leon Shi, PhD, Lan Li, MS, and Jing Shi, PhD, provide a high-level analysis of the significant changes to the guidance compared to the immunogenicity draft guidance released in 2016, and the implications for drug development programs.