news
FDA approves vaccine for smallpox and monkeypox
The Jynneos live, non-replicating vaccination for smallpox and monkeypox has been approved by the FDA for high-risk patients.
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Manufacturing
news
Global injectable drug delivery market predicted to grow 12.8 percent
Increasing demand for convenient drug delivery, as well as an increase in diseases such as diabetes, has fuelled the global injectable drug delivery market.
webinar
TOC fitness for purpose: How to ensure your TOC analyser is fit for compendial water & cleaning validation
19 September 2019 | By SUEZ
This webinar will present how to easily evaluate "fitness for purpose" of a TOC instrument for compendial water and cleaning validation applications based on USP and ICH Q2(R1).
news
Demand for containment facilities and manufacturing to grow
The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.
news
EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
news
Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
news
EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
article
Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
article
How tablet formulation can impact production
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
article
On the edge of glory: how close are we to fully automated continuous biopharma production?
We’re getting closer to something special with regard to how we manufacture biopharmaceuticals. Loe Cameron explores where the continuous bioprocessing journey could take us and what it might mean for medicine manufacturers worldwide.
whitepaper
Application note: Calculating maximum allowable carryover (MAC) for cleaning validation
This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.
article
Single-use strategies for downstream processing
All therapeutic developers and manufacturers are under intense pressure to improve efficiency and productivity and reduce costs, all while maintaining the highest quality standards.
article
Sartorius Stedim Biotech – offering innovative single-use technologies for advanced bioprocessing
Innovations in single-use process automation are driving single-use adoption into commercial biologics facilities. Here, Sartorius Stedim Biotech (SSB) shares its latest service offering.
article
Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
article
Expert View: Data integrity in the QC micro laboratory
The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. Jessica Rayser discusses the importance of data integrity to ensure safe and effective products are manufactured.
