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1 July 2019 | By Vanda Dolabela de Magalhães
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
26 June 2019 | By Thermo Fisher Scientific
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
25 June 2019 | By European Pharmaceutical Review
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
21 June 2019 | By Dr Christian Faderl - Project Coordinator Endotoxin LER Services at bioMérieux
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
21 June 2019 | By Bio-Rad
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
20 June 2019 | By James Mellman - Device Manager at Novartis
The increasing complexity of formulations and active biological products raises new challenges for pre-filled syringe development. James Mellman, Device Manager at Novartis, speaks to Nikki Withers about the challenges of selecting the right primary packaging for injectable formulations and how he has learnt to expect the unexpected.
18 June 2019 | By Victoria Rees (European Pharmaceutical Review)
A study has predicted that the global biopharmaceutical contract manufacturing market will grow by 10.6 percent from 2017 to 2027.
13 May 2019 | By Mike Wilson - Director Product Marketing Mass Spectrometry Systems
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
26 April 2019 | By European Pharmaceutical Review
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
26 April 2019 | By European Pharmaceutical Review
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
25 April 2019 | By European Pharmaceutical Review
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
14 March 2019 | By GORE
New product from Gore eliminates the need for silicone in both barrel and plunger of pre-filled syringes.
26 February 2019 | By GORE
Gore, a global materials science company, attends Pharmapack Europe to continue their year-long launch of the GORE™ ImproJect™ Plunger for pre-filled syringes...
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…
5 February 2019 | By Pharmapack Europe
Pharmapack Europe has released a ‘European drug delivery and packaging’ report, ahead of the event’s opening which highlights, major challenges and opportunities for the industry in the year ahead...
