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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

They are often heat sensitive, membrane impermeable, subject to enzymatic degradation, and susceptible to microbial contamination (a factor which impacts manufacturing steps and quality considerations). Small molecules have known structures and are primarily chemically synthesized. ADME and Dosing Regimen.

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Pharma Microbiology East Coast Conference – A Virtual Conference with Remote Access

pharmaphorum

Key sessions include: • Evaluating the ongoing Complications of Personnel Derived Contaminations. Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products. Culturing Contamination Prevention – Building a Sustainable Microbial Control Program from the Ground Up.

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April’s Regulatory Focus: Professional and career development

The Pharma Data

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

If not internally, such specialist training programmes can be outsourced to third-party organisations, whether that involves pharmaceuticals, in vitro diagnostics (IVDs) or QP training. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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Unlocking the potential of mRNA for the future treatment of rare diseases 

Drug Discovery World

As we turn our focus to new potential applications and disease areas for the platform, scientists and companies must consider the potential life-saving impact on rare, inherited diseases, says Archana Gupta , PhD, staff scientist in genetic sciences at Thermo Fisher Scientific.

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COVID-19 Pandemic Coverage

XTalks

Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.