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Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
1 March 2022 | By
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The Gates Biomanufacturing Facility announced a strategic agreement with Nkarta to manufacture Nkarta's investigational cell therapy NKX101.
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.
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.
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.
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
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).
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate...
The EMA has approved Janssen's continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir)...
The FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance.
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.
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.
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…
