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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

Vaccines 111
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Why pharma needs a revolution in culture

pharmaphorum

In 2014, six years after the global financial crisis forced the world’s biggest financial institutions into some serious navel gazing, the CEO of a major international bank was despairing: “We’ve put in place a best-in-class compliance system, but we can’t stop our people acting badly.

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EHA 2025: AstraZeneca’s surovatamig is potential next-gen BiTE for R/R B-ALL

Pharmaceutical Technology

The US Food and Drug Administration (FDA) approved Amgen’s Blincyto (blinatumomab), the first bispecific T-cell engager (BiTE), in 2014 for adults with Ph- R/R B-ALL, with its label expanded in 2017 to include Ph+ and paediatric cases. Give your business an edge with our leading industry insights.

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Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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Preparing for a post-pandemic world

pharmaphorum

And we transformed so quickly because the key players communicated and collaborated. COVID-19 also put global supply chains in the spotlight, as industry looked to remove obstacles and speed the delivery of material crucial to vaccine development processes. The post Preparing for a post-pandemic world appeared first on.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Published July 2014. Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies. Lo Surdo, J., Cauchon, C.

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Accommodating Multiple Modalities in the Same Facility

ISPE

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Viral antigen vaccines. For example: Live vaccine manufacturing. Complete Data Gathering.