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The rise of biosimilars – navigating regulatory complexity in Europe

30 December 2020 | By Gabriela Marton (Arriello)

Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.

syringe drawing from a vial in front of the EU flag (blue with a central circle of golden stars) - vaccines are an example of biopharmaceuticals

Seven secret ingredients for successfully launching and commercialising a biopharma’s first drug in Europe

23 December 2020 | By Christian Schuler (Simon-Kucher & Partners)

After the US, Europe is considered the second most attractive market for serving patient needs while realising commercial value from innovative drugs. However, the 27 EU member states each have their own approaches to pricing and market access – and need tailored commercialisation and go-to-market strategies. Simon-Kucher & Partners analysed…

Why cold chain requirements are not holding COVID-19 vaccines back

18 December 2020 | By Victoria Rees (European Pharmaceutical Review)

Despite the stringent storage conditions required for Pfizer and BioNTech’s COVID-19 vaccine, the need for a return to normal life has levelled the playing field for all candidate prophylactics against SARS-CoV-2.

Pioneering a full-ecosystem microbiota approach to improve survival outcomes in life-threatening diseases

16 December 2020 | By Hervé Affagard (MaaT Pharma)

The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…

Current innovations in the vaccine pipeline

16 December 2020 | By Alexa Trost (Avalere Health), Edric Zeng (Avalere Health), Nicholas J Diamond (Avalere Health), Sarah Moselle (Avalere Health)

As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…

Pharmaceutical bottle packaging – the quest for zero defects and data integrity

16 December 2020 | By Iván Avilés-Segundo (Pfizer), José-Miguel Montenegro-Alvarado (Pfizer)

This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…

Innovations in analytical science: development of rapid, high-throughput glycoanalytics for biopharmaceuticals

16 December 2020 | By Cristina Blood (CPI Biologics), Lewis Wharram (CPI Biologics), Martin Hulley (Allergan Biologics Ltd), Phil Widdowson (Allergan Biologics Ltd), Robert Dunne (GlycoSeLect Ltd), Roisin Thompson (CPI Biologics), Spyridon Gerontas (Allergan Biologics Ltd), Stuart Jamieson (CPI Biologics), Victoria Smith (CPI Biologics)

Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.

New opportunities for the global API market

15 December 2020 | By Vijith Menon (Market Research Future)

Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…

Improved in vitro renal tubular drug transport modelling to meet regulatory and development cost challenges

15 December 2020 | By Dr Colin Brown (Newcells Biotech)

Due to the high costs associated with drug discovery and the clinical demand for effective drugs, in vitro human cell-based kidney models using renal proximal tubule epithelia are becoming popular tools for early-stage testing. It is increasingly more important that in vitro models of renal drug transport are physiologically representative…

Vaccine innovation in the UK: SMEs and national capabilities

14 December 2020 | By Dr Gabriela Juárez Martínez (KTN), Dr Marcel Kuiper (KTN)

The UK Government is supporting the development of COVID-19 vaccines, including two innovative UK vaccine candidates. In this article, we describe the history of these candidates and introduce innovative small and medium enterprises (SMEs) and national capabilities that are working to combat the current pandemic and improve the UK’s vaccine…

Life sciences flow metrology challenges

14 December 2020 | By Dr Tracy Brown (TÜV SÜD National Engineering Laboratory)

To realise quality, yield and cost benefits, there is a clear need to develop expertise and capability in the flow measurement and characterisation of pharmaceutical powder and fluid flows within continuous manufacturing processes. Dr Tracy Brown from the TÜV SÜD National Engineering Laboratory in the UK has investigated potential flow…

Raman spectroscopy: a useful tool in the fight against COVID-19

14 December 2020 | By Nikki Withers (European Pharmaceutical Review)

Raman spectroscopy has numerous applications in the pharmaceutical industry, ranging from verification of raw materials to quality control of products. This article explores how researchers are using the technique to aid our understanding of SARS-CoV-2, potentially improving detection speed and methods of analysis.

Recent improvements in deep ultra-violet fluorescence devices for cleaning verification

14 December 2020 | By Dr Krishnakumar Chullipalliyalil (Cork Institute of Technology), Dr Michael McAuliffe (Cork Institute of Technology)

Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…

Where now with quality by design?

14 December 2020 | By Dave Elder (David P Elder Consultancy)

Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.

Formulation, Development & Delivery In-Depth Focus 2020

14 December 2020 | By European Pharmaceutical Review

Within this in-depth focus are articles explaining the numerous benefits of in vitro human cell-based kidney models to study nephrotoxicity and drug-to-drug interactions as well as discussing the measures taken by API manufacturers to successfully navigate the pandemic and the opportunities this presents.

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