Biotechnology Insights

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.

Life science trends: The price of life saving medicine

This report, the fourth in our Horizons: Life Sciences series, tests this vision of improved patient access. We draw on the perspective of more than 500 small, medium and large companies operating across North America and Europe to examine each submarket in detail, looking closely at the milestones that brought them to this moment and the trends that are shaping their future—trends that will determine how quickly the next revolution in life-changing medicine will unfold.

purple manufacturing plant with value stream map overlay

How to improve your manufacturing efficiency: Value stream mapping 101

Even with smaller budgets, there are ways to enhance manufacturing operations and boost production, quality, and speed. Here’s your guide to getting there, along with several value stream map examples.

Stainless steel, single-use, or hybrid: 7 questions to guide your decision

Manufacturers of therapeutic proteins face immense pressure to stay ahead of market trends and deliver complex product portfolios. Choosing the right manufacturing system from day one can reduce that pressure and position you for ongoing commercial success.