Drug Development

Meeting the stringent demands of global health authorities requires a comprehensive understanding of the safety and performance standards for disposable technology. Regulatory expectations for single-use bioprocess equipment focus on the thorough characterization of materials, the validation of sterilization processes, and the demonstration of consistent quality to ensure that patient safety is never compromised in the production of modern biologics.

Modern biopharmaceutical manufacturing increasingly relies on flexible fluid management to ensure sterile integrity and operational agility. The adoption of single-use bag manifolds represents a significant shift from traditional stainless steel infrastructure, offering enhanced safety, reduced cleaning validation requirements, and the ability to pivot production quickly in response to market demands.

Ensuring patient safety in biopharmaceutical manufacturing hinges on the absolute integrity of the sterile environment. Sterility and risk control in disposable bioprocess assemblies provides a robust framework for mitigating contamination risks, streamlining GMP compliance, and protecting high-value biological products through every stage of the aseptic processing workflow.

Strategically expanding production capacity requires a careful balance of technological investment and regulatory compliance. Scaling biologics with single-use fluid handling systems offers a pathway to rapid growth, enabling manufacturers to transition from clinical trials to commercial scale with minimized capital risk and enhanced operational flexibility in highly regulated environments.

Lupin and TB Alliance have entered into a strategic collaboration to advance the clinical development and commercialisation of Telacebec, an investigational drug for the...

Advances in thermal packaging, real-time monitoring, and sustainable cooling technologies are revolutionizing the way sensitive biologics and vaccines are transported, ensuring their efficacy remains uncompromised from the production line to the patient.

Abalone Bio, which is a therapeutics biotech company that distinctively measures and also makes utmost use of large-scale activity datasets in order to discover...