White Papers / Tech Papers

Colbert’s Clean Carton Passes the Test

One Clean Carton™ has been introduced to provide access to packaging that meets the highest standards for sustainable, pharmaceutical and food-safe packaging.

Critical Factors of Fill Finish Manufacturing For Biologics

The bulk drug substance, formulation, and sterile filtering and filling of the final drug product all require special handling procedures.

Released by: Ajinomoto Bio-Pharma Services

Is Your Complex Formulation Process Set Up for Success?

Often, the implementation of specialized equipment and/or processes is necessary to ensure successful formulation.

Released by: Ajinomoto Bio-Pharma Services

Polymers for Drug-Device Combination Products

Several polymers are available for drug-device combination product developers, many that meet necessary regulatory requirements.

Released by: Lubrizol LifeSciences

Preparing for Your CDMO Selection Process

Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing.

Released by: Ajinomoto Bio-Pharma Services

Critical Considerations for Coated Drug-Device Combination Product Development

In this technical brief, you will learn how improved patient outcomes have been made possible by innovation in therapeutic coatings for medical devices.

Released by: Lubrizol LifeSciences

Considerations for Development of Lyophilized Biosimilar

This whitepaper discusses considerations for development of a lyophilized biosimilar, as well as a biosimilar case study.

Released by: Baxter BioPharma Solutions

Successful Serialization Implementation With Open SCS

Open SCS – adding value to serialization standardization. Download the FREE white paper by ACG to learn more.

Released by: ACG North America LLC

The Evolution of Antibody-Drug Manufacturing

Download the FREE White Paper Released by MilliporeSigma.

Released by: MilliporeSigma

Big Data in Pharmaceuticals. Big Opportunities or Big Challenges – or Both?

Download this 6 minutes of insightful reading and make your own decision.

Released by: OSIsoft

Manufacturing of Cytotoxic and Non-Cytotoxic Drugs in a Multiproduct Facility

When different drug products are produced in shared facilities, the potential for cross contamination is always a concern.

Released by: Baxter BioPharma Solutions

Process Development for Lyophilized Products

A common approach to process development for lyophilized products is to thermally characterize the solution formulation to determine the critical product temperature that should not be exceeded during primary drying. This is conducted using different…

Released by: Baxter BioPharma Solutions

Support of Scale-Up and Technical Transfer Through Understanding Equipment for Lyophilization

Formulation and process development for injectable products are typically conducted at laboratory-scale. Laboratory-scale equipment is useful and necessary during development when there is little technical information available and especially when th…

Released by: Baxter BioPharma Solutions