Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

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Potential Benefits Drive Interest in Continuous Manufacturing

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process? Stéphanie Dubois, cell culture laboratory manager and application specialist at Pall Life Sciences, describes challenges and explains how alternative types of perfusion bioreactors can simplify the process.

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What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Continuous Bioprocessing Challenges

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

Determining Cross-Contamination Risks in Multiproduct Biopharmaceutical Facilities

There are a number of challenges when implementing a continuous monitoring system.

	The author presents issues encountered at Novo Nordisk and discusses how expanding the scope of monitoring, together with frequent and thorough review of data, can help keep a facility in compliance.

Challenges encountered when implementing a continuous monitoring system are reviewed.

Achieving and Maintaining Compliance Using Continuous Monitoring Systems

Establishing a sterilization process for liquids in containers involves trial and error, as pressure adjustments must be made during the heating, sterilization, and cooling phases. An alternate approach-cycles controlled by differential pressure-maintains the pressure in the chamber at a level that prevents the rigid containers from exploding and the non-rigid containers from becoming deformed.

sterilization approach-cycles controlled by differential pressure-is described.

Optimizing the Sterilization of Liquids in Sealed Containers

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär Almhem, president of ModWave, gives his perspective on modular systems.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

Using Modular Systems in Biopharmaceutical Manufacturing

Residual hydrogen peroxide (HP) from the vapor-phase HP (VPHP) isolator decontamination process can diffuse into drug product, potentially resulting in significant protein oxidation and thus impacting product quality. The effect of absorbed VPHP on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide and the stability of the lyophilized product was studied for up to six months.

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Determining Protein Oxidation Induced During Fill-Finish Operations

Application of single-use technology in a parenteral facility for syringe filling.

Pharmaceutical Technology-05-15-2014