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Active Pharmaceutical Ingredient (API)

FDA publishes recommendations on psychedelic clinical trial design

26 June 2023 | By Catherine Eckford (European Pharmaceutical Review)

New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.

news

New AMR certification launched for antibiotic manufacturers

6 June 2023 | By Catherine Eckford (European Pharmaceutical Review)

Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.

news

Analysis reports nitrosamine prevalence in small molecule drugs

5 June 2023 | By Catherine Eckford (European Pharmaceutical Review)

Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.

news

Automation to guide technology shift in aseptic environments

29 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.

article

European Pharmaceutical Review Issue 2 2023

24 April 2023 | By European Pharmaceutical Review

EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…

news

Could ATR-FT-IR spectroscopy become ‘gold standard’ for heparin analysis?

19 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

A paper states ATR-FT-IR spectroscopy plus multivariate analysis for heparin analysis is cost-effective compared to NMR.

news

Eli Lilly promises additional $1.6b manufacturing investment

18 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

A total $3.7 billion investment at LEAP Innovation Park in the US is Eli Lilly and Company’s largest manufacturing investment at a single location in its history.

news

Navigating delivery challenges of nucleic acid therapeutics

14 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

A paper has reviewed how novel drug delivery systems could achieve stable formulations of nucleic acid therapeutics.

news

Collaboration to produce 3D screen printed pharmaceuticals

22 March 2023 | By Catherine Eckford (European Pharmaceutical Review)

A new collaboration between two industry players for cGMP production of 3D screen printing technologies could reduce drug development costs.

article

Handling HPAPIs safely – what does it take?

9 March 2023 | By Catherine Eckford (European Pharmaceutical Review), Kishore Hotha (Veranova)

Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).

news

Enhancing bioavailability formulations containing soluble acidic drugs

2 March 2023 | By Catherine Eckford (European Pharmaceutical Review)

Research has revealed efficiency of a multi-compartmental dissolution method used to predict in vivo performance of BCS Class IIa compounds.

news

Bioavailability enhancement services market to exhibit 11 percent CAGR

27 February 2023 | By Catherine Eckford (European Pharmaceutical Review)

Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.

whitepaper

Application note: Rapid identification of Polysorbates 20 and 80 through amber bottles

27 February 2023 | By Agilent Technologies

How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.

article

Medicinal cannabis: the route to good manufacturing practice registration

21 February 2023 | By Arthur Wakeley, Catherine Eckford (European Pharmaceutical Review), James Short

Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.

news

Lonza completes bioconjugation facility expansion

16 February 2023 | By Catherine Eckford (European Pharmaceutical Review)

The planned expansion of Lonza’s bioconjugation facility in Visp, Switzerland has been completed, the company has announced.

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Active Pharmaceutical Ingredient (API)