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20 October 2025 | By
The balance between speed, scale, and compliance has never been more critical. As GLP-1s, biosimilars, and advanced therapies reshape global priorities, pharma leaders face a new question: how can manufacturing infrastructure evolve fast enough to keep pace?
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
Keeping up with the latest developments in pharma.
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
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.
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…
