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FEATURED EDITORIAL

Forget Tech Transfer. You Need A Cognitive Connection

Cognitive transfer is a concept widely studied in psychology. Today it has growing relevance within our industry’s ever-increasing technology transfers, which have been understood in the main as moving development/manufacturing processes/technologies from one stage, one location, or one organization – as when utilizing CDMOs – to another. Time now to zero in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation. This is where cognitive transfer enters our portal. Here's an analysis.

GUEST COLUMNISTS

Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity
Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
Navigating GMP Biosafety Challenges In ATMP Manufacturing
BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.
Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

PHARMA OUTSOURCING WHITE PAPERS

Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.

Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
Methods For Determining Equipment Capability Of Freeze-Dryers
Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
Stopper Migration In Frozen Pre-Filled Syringes
Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.
The Role Of Extractables Data In The Adoption Of Single-Use Systems
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
Strategic Hiring For Scalable Success
Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.