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GMP manufacturing

Pharma & Biotech

How Andelyn Biosciences is targeting GMP scale-up challenges in lentiviral vector manufacturing

Cell therapy needs lentiviral vectors, but GMP scale-up remains messy. Andelyn Biosciences is betting standardization can close that gap.

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Pharma & Biotech

What Plus Therapeutics Inc.’s SpectronRx partnership reveals about radiopharmaceutical manufacturing readiness

Discover how Plus Therapeutics Inc. is scaling REYOBIQ manufacturing for pivotal trials and what it means for radiopharmaceutical innovation.

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Pharma & Biotech

How Kenox Pharmaceuticals is targeting the OINDP CDMO gap with integrated clinical manufacturing

Kenox Pharmaceuticals announces clinical manufacturing readiness for inhaled and nasal drug products. What this means for OINDP development timelines and IVBE strategy.

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Pharma & Biotech

Psyence Biomedical Ltd. advances natural psilocybin development with Phase IIb cancer distress trial

Psyence Biomedical Ltd. advances natural psilocybin therapy in a Phase IIb cancer distress trial. Explore what this means for psychedelic medicine development.

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Pharma & Biotech

Is Ossium Health redefining bone marrow transplants with off-the-shelf cryopreservation?

Ossium Health’s cryopreserved bone marrow is showing early clinical success. Find out how this could disrupt allogeneic transplantation logistics.

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Pharma & Biotech

Vaxxas earns GMP licence for HD-MAP production—what this unlocks for clinical trials

Vaxxas Pty Ltd, the Australian biotechnology company known for its high-density microarray patch (HD-MAP) platform, has secured a manufacturing licence from the Therapeutic Goods Administration (TGA) to produce its investigational vaccine delivery system under Good Manufacturing Practice (GMP) conditions. The licence, granted for its Brisbane-based biomedical facility, clears a critical regulatory hurdle and allows Vaxxas

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Pharma & Biotech

How Staccato technology positions Lee’s Pharmaceutical for CNS drug delivery leadership

Lee’s Pharmaceutical Holdings Limited has acquired the Staccato One Breath Technology platform and related assets from Alexza Pharmaceuticals, gaining exclusive rights to manufacture and license Staccato alprazolam under its global agreement with UCB. The transaction expands Lee’s Pharmaceutical’s inhalation drug delivery pipeline, deepens its foothold in central nervous system therapies, and positions the company to

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