Biotechnology Insights

Performing a risk assessment in a biotech manufacturing facility

Risk assessment strategies for life sciences manufacturing

Risk assessment is a formal methodology for evaluating potential hazards and risks to processes, programs, organizations, patients, and operators.

5 process improvements for plasma fractionation and purification

Here are five mini-case studies that improved the production process for plasma-derived proteins because every drop of plasma counts.

High ROI, low emissions: The heat pump advantage for biopharma

Examples of why biopharma is making the switch to heat pumps from traditional gas-fueled heating systems

GMP guidelines for ATMP manufacturing: A practical guide to risk-based compliance

Five Annex 1 questions answered, with expert guidance

When it was first released in the 1970s, Annex 1: Manufacture of Sterile Medicinal Products filled an important gap in the regulatory landscape by formalizing EU regulators’ expectations for maintaining product sterility through facility design and operation.

Simulated cleanroom airflow visualizations ahead of construction

How Computational Fluid Dynamics (CFD) is being used in pharma to validate cleanroom air flow and HVAC designs instead of traditional smoke tests

Efficiency is the destination. Innovation is the vehicle. Manufacturers, start your engines.

The life science industry is shifting gears, widening the gap in the race for next-generation solutions. This facility-focused report will help you get (and stay) ahead.

Radiopharmaceuticals: A guide for manufacturers

Already well-established in the field of diagnostic imaging, radiopharmaceuticals are emerging as powerful therapeutic weapons against cancer. To realize their potential, manufacturers must overcome significant challenges—in particular, the challenge of producing and distributing drugs whose potency may last no more than a few hours.

Targeted therapies: An introduction to ADC manufacturing

Manufacturers are poised to take advantage of the growth of the antibody-drug conjugate (ADC) market. To do so they need to understand the process technologies involved, as well as the manufacturing challenges.

Operational improvement as the gateway to efficient ATMP production

Even a minor operational improvement can generate major benefits for ATMP manufacturers, particularly when personalized therapies are involved. Unlock these benefits in your own facility by using the tools of operational improvement to answer six mission-critical questions.