Technical Papers

555 Results

Understanding the 505(b)(2) Approval Pathway

Understanding the 505(b)(2) Approval Pathway

Camargo Pharmaceutical Services | 11-Jun-2013 | Technical / White Paper

When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway...

ATMI

Virus Production: From Bench to Industrial Scale

ATMI Life Science | 10-Jun-2013 | Case Study

Discover the linear scale-up of various viral production process using the Integrity® iCELLis®, a scalable range of disposable fixed-bed bioreactors operating...

Biosimilar Development: The Race to Market

Biosimilar Development: The Race to Market

SGS Life Science Services | 10-Jun-2013 | Technical / White Paper

This article provides an update on the current regulatory situation for biosimilars, and addresses the issues with demonstrating physicochemical similarity,...

Conversion of Legacy Data to CDISC

Conversion of Legacy Data to CDISC

SGS Life Science Services | 03-Jun-2013 | Technical / White Paper

Legacy data submitted to the FDA should be in a standardized format. This article is a summary of the FDA´s recommendations to approach the conversion...

ATMI

How to Industrialize Stem Cell Culture Processes?

ATMI Life Science | 27-May-2013 | Technical / White Paper

Learn about the scale-up of allogeneic stem cell processe, from multi-tray stacks to the Intergity® XpansionTM multiplate bioreactor. Results demonstrated...

Id Counterfeit Pharmaceuticals with Portable Raman

Id Counterfeit Pharmaceuticals with Portable Raman

Rigaku Raman Technologies | 22-May-2013 | Technical / White Paper

The growing danger of counterfeit and substandard medicines entering the supply chain is a concern for global pharmaceutical manufacturers and consumers....

505(b)(2): It’s A Different Animal

505(b)(2): It’s A Different Animal

Camargo Pharmaceutical Services | 13-May-2013 | Data Sheet

505(b)(2) is more than a regulatory pathway — for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development...

Choosing the Right Dimension of Purity

Choosing the Right Dimension of Purity

Croda Inc | 29-Apr-2013 | Data Sheet

Drug active stability and formulation efficacy can be negatively affected by excipient impurity.  Additional purity can be valuable in protecting the drug...

Stepan

ONAMER® M Preservative and Antimicrobial Agent

Stepan Lipid Nutrition | 22-Apr-2013 | Case Study

ONAMER® M is a biocide agent suitable in a variety of liquid drug formulations. Its high safety and low toxicity profile makes it especially advantageous...

 Increasing Accuracy, Not Costs

Increasing Accuracy, Not Costs

METTLER TOLEDO | 11-Apr-2013 | Case Study

Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects...

Sensitivity Over Oleic Acid

Sensitivity Over Oleic Acid

Croda Inc | 01-Apr-2013 | Data Sheet

Is oleic acid irritating you?  Super Refined® oleic acid can reduce cellular irritation as well as improve the oxidative stability of your formulations,...

White Paper: Is My Method Still Valid?

White Paper: Is My Method Still Valid?

SGS Life Science Services | 26-Mar-2013 | Technical / White Paper

The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with little deviation....