At Lonza, we have developed our CFS 1200® capsule filling and sealing machine as part of our Lonza Engine™ portfolio. Used with our Capsugel® capsules, pharmacies can automate this process to optimise operations and accuracy. This fact sheet will introduce you to its handling and sealing capabilities, key benefits, performance…
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Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
Reducing unnecessary regulatory burden relating to excipients is important for any pharmaceutical manufacturer. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Kalyan Janjanam discuss a rational basis for controlling and specifying conflicting excipient attributes to avoid potentially tedious and complex regulatory processes.
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
Hosted online from 11 – 12 November, Chemspec Digital 2020 provides an interactive networking event for the fine and speciality chemicals community. From all over the world, industry experts will have the opportunity to meet, conduct business, discover innovative substances and learn about the latest trends and developments.
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
Researchers have developed a novel tablet formulation of ibandronate which increases the oral bioavailability of the drug by releasing it from a hydrogel raft formed in the stomach.
A report has said that the highly potent compound market will grow to be worth $32,200 million by the end of 2026.
A new report has said that a quarter of drugs globally are based on highly potent active pharmaceutical ingredients.
A new HPAPI manufacturing unit has been opened in France, with the capability to make a contraceptive with a superior safety profile and high level of biodegradability.