Application Notes & Whitepapers 2018
Keeping up with the latest developments in pharma.
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Articles
The data challenges of research & development and collaboration
In the biopharmaceuticals industry today, only 13 percent of therapeutics that enter Phase 1 of clinical trials go on to launch1 – and the total journey from R&D to market can be anywhere between eight and 12 years.2
Expert View: Raman imaging and spectral database management for pharmaceutics
Sophisticated hardware and software offer speed and precision. Pharmaceutical development often involves samples in solution or on transparent substrates. For these applications, confocal Raman imaging using an inverted beam path is an especially versatile and powerful investigative method.
Expert View: What ADC evolution means for manufacturing
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
Navigating roadblocks to clinical success: from molecule to clinic
For emerging biotech and small companies in early-stage clinical development, accessing the market as quickly as possible is of paramount importance. Biopharma executives must make important decisions at this stage that will impact the success of their commercial strategy. The key to success is making the right decisions at the…
Formulation, Development & Delivery In-Depth Focus 2018
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
Biopharma, Processing & Development In-Depth Focus 2018
In this supplement: navigating roadblocks to clinical success, and the data challenges of R&D and collaboration.
Raman In-Depth Focus 2018
This In-Depth Focus covers drop-coating deposition Raman (DCDR) spectroscopy for metabolite profiling and recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines.
Issue 6, 2018
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
Shehnaaz Suliman Theravance Biopharma: ‘Being a healer in the face of inequality’
As part of EPR’s Women Inspiring Pharma series, Shehnaaz Suliman, SVP, Business Development and Strategy, Theravance Biopharma talks to Science Editor Dr Zara Kassam about fighting for human rights, inequality and the challenges women face in their careers...
Solid-state NMR spectroscopy: predicting stability in lyophilised biological products
The emergence of biological drugs has led to an increase in lyophilised drug products in the market. Lyophilisation is a technique used to stabilise parenteral formulations in a solid form with the goal of producing chemically and physically stable, homogeneous, and high-quality lyo-products.
LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics
For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…
Brexit – will all the medicines get to the patients?
Two years after the UK narrowly voted to exit the EU it remains unclear as to what this may involve. In July 2016, Theresa May stated that “Brexit means Brexit.” But what exactly did that mean?
Integrating data from QC and Production to enable fast, informed decisions
Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…
NIR inspection of each tablet that exits a tablet press
In the pharmaceutical industry, waste represents at least 25% of the cost of quality. In 2004, the Food and Drug Administration (FDA) published a guide to promote the implementation of Process Analytical Technologies (PATs) in the pharmaceutical industry. This would allow better quality control (QC) and monitoring directly on the…
