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Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
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Biologics
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Sandoz to move headquarters to Basel, Switzerland
As Sandoz prepares to become standalone company, the generic and biosimilar firm has declared it will base itself in Basel, facilitating closer collaboration.
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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Nanoparticle HIV vaccine shows potential in trial
Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.
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Scientific journal: Planning your first-in-human trial
This issue of The Altascientist provides a thorough review of the first-in-human clinical trial process, including planning and conduct.
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Five proposed biosimilars planned for development in Europe
The extended partnership agreement between Alvotech and Advanz Pharmaceutical includes a biosimilar candidate to Entyvio® (vedolizumab).
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First redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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Press release: SGS launches SGS PACE, a streamlined pathway through preclinical, formulation, FIH and POC
SGS PACE is a seamless combination of world-leading development, bioanalysis and clinical research through one point of contact.
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AI-driven biosimilar manufacturing partnership announced
Artificial intelligence technology will drive manufacture of high-quality biosimilars at scale under a partnership between Sandoz and Just - Evotec Biologics.
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RWE shows efficacy of nirsevimab for infant RSV
New real-world data “adds to the evidence that use of long-acting monoclonal antibody [nirsevimab] may prevent moderate to severe respiratory syncytial virus disease” in infants after single dose.
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Could personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.
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Realising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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Sandoz to boost biosimilar development with manufacturing expansion
€25m funding is intended to unite a cutting-edge biotech lab and analytical expertise at Sandoz's German biosimilar manufacturing site.
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Transforming oncology with antibody therapeutics
Martin Vogel, Therapeutic Area Lead for Oncology, Janssen EMEA, discusses the potential of bispecific monoclonal antibodies like amivantamab to address unmet needs in advanced non-small cell lung cancer treatment.
