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Aristea Therapeutics

How Involved Should Biopharma CEOs Be In Outsourcing Activities?

When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes? Louis Garguilo interviews …

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5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch, presents a set of an …

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Contamination Control Strategy

Regulatory bodies expect that pharmaceutical companies have a Contamination Control Strategy (CCS) in place that outlines the control of contamination of utilities, manufacturing systems and …

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Digitisation versus Digitalisation – Understanding the Difference and the Role of LIMS in Achieving Both

The system infrastructure for the creation, storage and management of electronic data has to be in place. If this isn’t the case, then completing a …

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Predicting Drug Bioavailability with the Modern-day Toolkit

Bioavailability is defined as the fraction of drug reaching systemic circulation following absorption in the gut and first-pass metabolism in the liver. Accurately predicting the …

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SLIM: A Gateway to the Adoption of High-Resolution Ion Mobility for Biotherapeutic Peptide Mapping

The demand for protein therapeutics, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, has grown significantly over the past decade. Often developed …

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An End-to-End Solution to Accelerate CAR-T Cell Development from Concept to Clinic

CAR-T cell therapies have demonstrated tremendous success in relapsed or refractory haematological malignancies. Now therapeutics companies and academics alike are racing to break through the …

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Disease Models

Benefits & Key Considerations of Using Human iPSC-Derived Disease Models in Drug Discovery

The process of drug discovery, development and commercialisation is long and associated with high costs. In addition, it is estimated that only 1% of the …

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clinical metadata repositories

Could Standardised Metadata be the Key to Optimising and Expediting Clinical Trials?

Clinical trials still offer the most effective way of testing the safety and efficacy of new drug treatments, and as more drugs are brought through …

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CGT CDMO Partnering: More than just Manufacturing

The biotech footprint has been exponentially expanding around the globe and no division has increased more feverishly in recent years than the Cell and Gene …

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Maximising mAbs Purification Efficiency: Focus Areas for Reducing Bottlenecks in Downstream Processing

Finding ways to remove bottlenecks and improve yields in downstream processing for monoclonal antibodies (mAbs) continues to be a key focus area for biopharma manufacturers. …

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Advanced therapy medicinal products

Bringing Novel Therapies to Market: 5 Strategies for Success

Advanced therapy medicinal products (ATMPs) were making headlines long before SARS-CoV-2, the virus that causes COVID-19, emerged onto the scene. The successful development of COVID-19 …

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breast cancer

Understanding the Role of Regulatory T Cells in Breast Cancer Metastasis

Breast cancer is the most common cancer amongst women accounting for 24 percent of new cancer cases worldwide and 15 percent of cancer deaths in …

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