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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…
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…
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.
In this supplement: navigating roadblocks to clinical success, and the data challenges of R&D and collaboration.
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.
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.
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...
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.
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…
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?
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…
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…
In this Spotlight on Continuous Manufacturing, RCPE facilitates the adoption of novel manufacturing technologies...
The microbial population in water is dynamic and may change not only from day to day but also at different times of the day. Researchers have observed that this microbiological distribution usually follows the Poisson or Negative Binomial model.1
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.
