Active Pharmaceutical Ingredient (API)

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Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies

7 March 2019 | By Dr Holger Kranenburg - containment lead at Franz Ziel GmbH, James L. Drinkwater - Head of GMP Compliance at F Ziel GmbH

Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…

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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC

21 February 2019 | By Hyglos-bioMerieux

This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…

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Interphex New York: FPS confirm their presence for 2019

6 February 2019 | By FPS Food and Pharma Systems

FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions (sterile and highly toxic API)...

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Flyer: Sterile manufacturing – finished dosage forms

23 January 2019 | By Eurofins CDMO

Eurofins CDMO provides a wide range of aseptic processing services for all drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes to help develop your Active Pharmaceutical Ingredient or bulk product into Finished Dosage Forms for use in clinical…

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Global APIs market predicted to reach $245.2 billion by 2024

7 January 2019 | By European Pharmaceutical Review

Major factors driving the growth of the global APIs market are thought to be the increasing incidence of chronic diseases, growing importance of generics, and the increasing uptake of biopharmaceuticals...

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Tailor-made excipients, developed the Kolb way

20 December 2018 | By Kolb

Standard excipients can be sourced from various suppliers, but what if you need to customise an excipient to suit your needs?

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Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control

19 December 2018 | By Kaiser Optical Systems

The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1

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Application Notes & Whitepapers 2018

19 December 2018 | By European Pharmaceutical Review

Keeping up with the latest developments in pharma.

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Application Note: Verification of three different Opadry whites using a handheld Raman analyser

12 December 2018 | By Thermo Fisher Scientific

Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.

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Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity

12 December 2018 | By SUEZ

Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.

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Application Note: Tracking fate and purge of impurities and calculating carryover

12 December 2018 | By ACD/Labs

The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.

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Scientific Poster: How complementary chromatographic methods can support a full analytical picture in pharmaceutical drug development

12 December 2018 | By MilliporeSigma

HPLC is a rapid, accurate and sensitive method for determination of pharmaceutical drugs, degradations and impurity profiling. It is a preferred method for analytical characterisation during drug development.

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CPhI report forecasts India to have strongest global growth in 2019

6 December 2018 | By CPhI India

CPhI & P-MEC India opens as report ranks India the world’s fastest improving pharma market and first for ‘growth potential’ for 2019...

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Whitepaper: ABCs of reference standard management

27 November 2018 | By Eurofins

Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support.

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Whitepaper: Ten things you should know before contracting a custom synthesis project

26 November 2018 | By Eurofins

Companies often need to arrange for the synthesis of test substances to support research and development efforts.