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Aseptic manufacturing training supported by Cherwell Laboratories
15 June 2016 | By Cherwell Laboratories
Cherwell process validation & environmental monitoring product range on display at APDM training course...
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Manufacturing
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Allecra Therapeutics closes €22 Million Series B financing round
15 June 2016 | By Victoria White, Digital Content Producer
The proceeds will fund Phase II development of AAI202 - a novel antibiotic combination designed to treat drug-resistant Gram-negative bacterial infections...
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Study finds biosimilar switching not suitable for all patients
10 June 2016 | By Victoria White, Digital Content Producer
A study presented at EULAR showed that when antibodies develop in response to the infliximab, they also cross-react with the biosimilar of infliximab...
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Efficacy and safety of Biogen’s anti-TNF biosimilars presented at EULAR
9 June 2016 | By Victoria White, Digital Content Producer
Data demonstrating long-term comparable efficacy, safety and immunogenicity of Benepali (etanercept) and Flixabi (infliximab) have been presented at EULAR...
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Infliximab biosimilar Flixabi approved in the EU
31 May 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade...
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Eppendorf expands single-use vessel portfolio for microbial fermentation
31 May 2016 | By Eppendorf
Eppendorf's BioBLU 3f Single-Use Vessels specifically address the demands of high cell density fermentation of bacteria, yeasts and fungi...
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Helperby’s new approach to fighting resistant bacteria
23 May 2016 | By Victoria White, Digital Content Producer
Helperby is about to begin clinical studies of a completely new approach to fighting resistant bacteria following a positive meeting with the FDA...
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Soligenix on IDR technology and SGX942
10 May 2016 | By Victoria White, Digital Content Producer
We discuss Innate Defense Regulator (IDR) technology with Soligenix's Chief Scientific Officer, Dr Oreola Donini, and find out more about SGX942...
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MGB Biopharma and FDA discuss MGB-BP-3 regulatory strategy
9 May 2016 | By Victoria White, Digital Content Producer
MGB Biopharma presented Phase I and preclinical data together with a proposal for the further development of oral MGB-BP-3 in C. difficile infections...
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Quotient Clinical and Upperton announce a spray drying partnership to deliver integrated formulation development and GMP manufacturing programs for poorly soluble drugs
4 May 2016 | By Quotient Clinical
Quotient Clinical and Upperton have announced a partnership to address drug delivery challenges...
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Issue #2 2016 – Digital edition
In this issue: Regulation, Oncology, Single Use, Robotics, Microbiology, PAT, Mass Spectrometry, Drug Delivery, Nanotechnology, and much more...
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Single Use: In-Depth Focus 2016
In this Single Use In-Depth Focus: Disposables for continuous viral clearance for the production of monoclonal antibodies; Managing the quality of biologics manufactured by single use systems: A Japanese perspective; Single Use Q&A...
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A novel approach in assessing the antimicrobial efficacy of eye drop products
4 May 2016 | By Mostafa Eissa, Hikma Pharmaceuticals
The microbial contamination of medicinal products constitutes a continuous threat to the health of consumers, which may negatively impact pharmaceutical companies’ reputability. However, multidose sterile pharmaceutical products are prone to contamination either from the normal flora of the human body or from the surrounding environment, following their misuse by patients.…
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Exploring the advantages of PAT for pharmaceutical cleaning in Ireland
4 May 2016 | By Adeyinka Aina, University of Nottingham / Manuel Kuhs, Bernal Powder Engineering Research Group / Shaza Darwish, University of Limerick / Chris Edlin, Pharmaceutical Technology Manufacturing Centre
Process analytical technology (PAT) and its applications have been used in various industrial processes for a long time. It originates from the last century where its first application was in Germany after World War II within the chemical and petrochemical industry1. Following this, it was implemented and refined in different…
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Pall Life Sciences Launches Commercial Cadence Acoustic Separator for Intensified Bioprocess Clarification and Purification Applications
3 May 2016 | By Pall Life Sciences
The Cadence Acoustic Separator applies acoustic wave separation technology in a single-use format for the clarification of cell culture bioprocess fluids...
