news
Gates biomanufacturing facility announces agreement with Nkarta
The Gates Biomanufacturing Facility announced a strategic agreement with Nkarta to manufacture Nkarta's investigational cell therapy NKX101.
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Good Distribution Practice (GDP)
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Why real-time environmental monitoring is the most important aspect of the modern pharmaceutical cold chain
Glenn Abood, founder and CEO of rfxcel, explains how real-time environmental monitoring can combat supply chain shortcomings, providing companies with level of data integrity, traceability, transparency and security that is virtually beyond reproach.
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
news
UK pharmacist who illegally sold drugs sentenced in court
Jasper Ojela, a registered pharmacist who admitted to supplying the black market with drugs including cancer medications, has been given a 28-month prison sentence.
Whitepapers/App Notes/Posters
Whitepaper: The impacts of Brexit on the bio/pharmaceutical industry
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
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ABPI respond to statement of UK Government’s medicines regulation plans
The ABPI has responded to a joint letter from Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, published by the Financial Times, that outlined the UK Government’s plans for the regulation of medicines as the UK leaves the European Union (EU).
news
FDA approves cryopreserved formulation of ReNeuron’s candidate
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
news
EMA approves Janssen’s Prezista continuous manufacturing line
The EMA has approved Janssen's continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir)...
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FDA approves BioMarin’s manufacturing facility in Cork, Ireland
The FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance.
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Yusen Logistics Indonesia acquires highest standard of quality certification for pharmaceuticals transportation
PT Yusen Logistics Indonesia has become the first logistics business in Indonesia to acquire GDP certification, the industry standard of quality for the storage and transport of medical and pharmaceutical products.
news
Yusen Logistics opens Global Pharma Airfreight Gateway at Amsterdam Schiphol
The official opening ceremony was performed by Mr Hiromitsu Kuramoto, President of Yusen Logistics. Mr. Kuramoto joined with Yusen Logistics colleagues in welcoming guests including customers, Airport officials and Customs authorities at the inauguration event.
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Foreword: The importance of good distribution practice
Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the…