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Product hub: Documentation at your fingertips
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
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Regulation & Legislation
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Co-creating solutions that advance global health innovation – IFPMA’s role
The COVID-19 pandemic has altered and continues to shape our lives. Here, Thomas B Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), gives insight into how the pandemic gave impetus to the organisation’s manifesto to innovate and save lives.
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Brochure: The new Sievers M500 online TOC analyser
The Sievers reagentless membrane conductometric TOC detection method delivers reliable, robust and accurate data for pharmaceutical water applications.
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NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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Case study: Delivering a world class cell and gene therapy suite
RoslinCT and Connect 2 Cleanrooms have worked in partnership to deliver a world-class cell and gene therapy facility.
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FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
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Formulation, Development & Delivery In-Depth Focus 2021
Discover how to plan for post‑market clinical follow-up compliance under the new EU Medical Device Regulation (MDR), and formulate live biotherapeutic products to enhance their effects in this in-depth focus.
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Opdivo® approved in Europe to treat a range of cancers
Opdivo® (nivolumab) has been approved by the European Commission for gastric, gastroesophageal junction (GEJ), or oesophageal adenocarcinoma.
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European Pharmaceutical Review Issue 5 2021
Articles in this issue discuss the importance of diversity and inclusion in pharma, how packaging can improve big pharma's bottom line and why innovation has been vital to saving lives during the COVID-19 pandemic. Also in this journal, 10 key considerations when creating an ATMP manufacturing facility and how to…
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Whitepaper: Faster isolation of PBMC with Centrifuge 5910 Ri
Save up to 88% of deceleration time for your PBMC isolation due to optimized breaking ramps of Eppendorf Centrifuge 5910 Ri.
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FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
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FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
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On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
