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Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
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Formulation
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Whitepaper: SARS-CoV-2 vaccines and biosafety
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
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COVID-19 S-Trimer vaccine candidates show promise in early trials
When adjuvanted with GSK’s pandemic adjuvant system, the S-Trimer vaccine candidates induced the production of neutralising antibodies in all trial participants.
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Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
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Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
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iPDF: Pharma analysis & QC interactive detailed workflow
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
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Potential anti-COVID-19 nasal spray developed by researchers
A new nasal spray with ingredients already approved for use in humans could be used to protect people against COVID-19.
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Fact sheet: CFS 1200® capsule filling and sealing machine
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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Interactive PDF: Risk mitigation and quality requirements interactive tool
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
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Cannabinoid series: developing a synthetic CBD tablet
Aubrey Dan explains how EmpowerPharm developed its synthetic CBD tablet and why a novel formulation could help combat a range of indications.
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How a global network provides a genuine advantage
When a client gets an opportunity to expand rapidly, it takes a global partner to pull it off without a hitch.
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Science and risk-based specification setting for excipients
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.
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Approval of regulatory starting materials
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…
news
First-in-human trial to study remestemcel-L as Crohn’s disease therapy launched
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.
