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Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

By investing in advanced labs, manufacturing facilities, regulatory compliance systems, cybersecurity, and global supply chains, companies can ensure they meet […] It ensures scalability, quality control, and regulatory compliance.

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Genentech to onshore US manufacturing amid rising drug pricing tensions

Pharmaceutical Technology

Genentech has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in North Carolina.

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Accelerating FIH Biologics Manufacturing with Membrane Protein A Chromatography

XTalks

This surge underscores the increasing demand for efficient, cost-effective manufacturing processes, particularly in early-phase clinical programs. For contract research, development and manufacturing organizations (CRDMOs), this means rethinking legacy purification platforms that may no longer meet the demands of early-phase production.

Protein 92
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FDA rejects Ultragenyx gene therapy over manufacturing concerns

Bio Pharma Dive

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather than a roadblock.”

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Making the Case for Case Management for Cell and Gene Therapies

A dedicated Case Manager provides end-to-end supply chain management and 24/7 oversight and support to help ensure the seamless manufacturing and distribution of each therapy dose to every patient.

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UK project addresses capacity issue in CGT manufacturing

pharmaphorum

A UK consortium has been set up to tackle a major issue in the development of cell and gene therapies (CGT) – a lack of manufacturing capacity.

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Roche plans $700m manufacturing plant in the US  

Pharmaceutical Technology

The new site will support Roche and its unit Genentech's future portfolio of next-generation obesity medicines.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.