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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. There are many variabilities with biosimilars and the brand name protein drug.” For biosimilars, however, this process is slightly more complex.

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Going big: How cartridges are making large-volume, high-dose subcutaneous autoinjectors a reality

Pharmaceutical Technology

But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible. mL or less and use a prefilled syringe (PFS) with a staked needle as the drug’s primary container.

Protein 130
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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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The path to improved safety of gene-based products

Drug Discovery World

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

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Improving quality control for CAR T cell therapies

Drug Discovery World

To overcome this evasion tactic, the CAR protein was developed to recognise other markers on cancer cells. CAR is a fusion protein composed of an extracellular antibody fragment that recognises antigens and an intracellular domain that directs the T cell to the tumour. Identifying the right CAR T cell target.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider). Bahassi during the webinar and is shown in Table 1.