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How to Implement a Gold Standard FSP Partnership to Maximize Quality, Efficiency and Operational Effectiveness
Sunday, December 01, 2024

The strategic selection of an appropriate functional service provision (FSP) partner is crucial for biotech and biopharma organizations if they want ... read more
An Interview With Richard Castledine
Sunday, December 01, 2024

The pharmaceutical industry is facing significant challenges and opportunities when it comes to active pharmaceutical ingredient (API) sourcing and ... read more
Control and Selection of API Solid State Attributes
Wednesday, March 01, 2023

A stable, reproducible solid form is the basis of the majority of pharmaceutical dosage forms, including tablets, capsules and inhaled products. ... read more
Facility Tour: Advancing Inhaled and Injectable Product Development
Wednesday, March 01, 2023

The path to bring a pharmaceutical product to market, from initial research to development to commercial-scale manufacturing, is a long and resource-... read more
An Interview with Dr. Uwe Hanenberg - Head of Product Development, Oral Solid Dose
Wednesday, March 01, 2023

The company has the expertise and capability to work with formulations for new chemical entities (NCEs), improve products with existing drug ... read more
The Renaissance of Small Molecule Drug Discovery
Thursday, September 01, 2022

With biologics dominating headlines, one might be tempted to think that small molecule discovery is fading, or that there is little viable target and ... read more
Data Utilization for Life Sciences: Looking Forward and Back to Shape What’s Ahead
Monday, May 16, 2022

Over the course of the last two decades, the healthcare industry has witnessed the digitization and consolidation of data to improve scientific ... read more
Managing Risk in API Manufacturing is the Key to Successful Projects, Safer Drugs
Tuesday, November 30, 2021

Because of the nature of the business, every drug manufacturer faces the risk of unexpected events that can cause harm to consumers and cost the ... read more
API Supply Chain
Wednesday, December 16, 2020

As the COVID-19 pandemic continues to rattle economic markets it is becoming apparent that the pharmaceutical industry’s overreliance on APIs coming ... read more
API Manufacturing Can Be Riskier Than You Think Six Best Practices to Minimize Risk and Avoid Time and Cost Over-Runs
Thursday, December 10, 2020
Ed Price
The API manufacturing business can be a risky one – especially when dealing with chemical substances that will be consumed by humans. But it’s not ... read more

View Article Archives »

Tuesday, May 22, 2018
Raw Materials, Excipients and APIs
Pharmaceutical raw materials include both active pharmaceutical ingredients (APIs) and inactive ingredients or excipients. APIs are bulk drugs that ... read more
Friday, January 01, 2010
Regulatory Strategy for Starting Material Designation
The purpose of this paper is to lay out the regulatory considerations related to the choice of starting materials and synthetic route for an API. read more
Thursday, August 09, 2018
Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products
Stability is a critical quality attribute of pharmaceutical products and is a function of many factors, including the active drug substance itself, ... read more
Tuesday, January 29, 2013
Building a Sustainable API Supply Chain
An active pharmaceutical ingredient (API) sourcing strategy is built upon a well-defined manufacturing process. The keys to the strategy involve using... read more
Wednesday, September 25, 2013
Industrial Crystallization of Pharmaceuticals: Capability Requirements to Support an Outsourcing Paradigm
The demands for increasing control of drug substance physical properties in the pharmaceutical industry have evolved considerably in the past decade... read more

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How to Implement a Gold Standard FSP Partnership to Maximize Quality, Efficiency and Operational Effectiveness

An Interview With Richard Castledine

Control and Selection of API Solid State Attributes

Facility Tour: Advancing Inhaled and Injectable Product Development

An Interview with Dr. Uwe Hanenberg - Head of Product Development, Oral Solid Dose

The Renaissance of Small Molecule Drug Discovery

Data Utilization for Life Sciences: Looking Forward and Back to Shape What’s Ahead

Managing Risk in API Manufacturing is the Key to Successful Projects, Safer Drugs

API Supply Chain

API Manufacturing Can Be Riskier Than You Think Six Best Practices to Minimize Risk and Avoid Time and Cost Over-Runs

API Articles - Most Viewed

Raw Materials, Excipients and APIs

Regulatory Strategy for Starting Material Designation

Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products

Building a Sustainable API Supply Chain

Industrial Crystallization of Pharmaceuticals: Capability Requirements to Support an Outsourcing Paradigm

Subscriptions

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