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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms. 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).

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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. Container Closure Integrity Evaluation: USP Perspective. • Container Closure Integrity and Controls Strategies Ensuring Product Sterility. Container Closure Integrity Evaluation: USP Perspective. • in Biology and Ph.D.

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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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Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).

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First Monkeypox Test Approved by WHO for Emergency Use

XTalks

The approval was awarded to Abbott’s Alinity m MPXV assay, the first mpox in vitro diagnostic (IVD) listed under the WHO’s Emergency Use Listing (EUL) procedure. It is intended for use by trained clinical laboratory professionals skilled in PCR techniques and IVD procedures. Mpox has led to at least 635 deaths in the DRC this year.

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COVID-19 Pandemic Coverage

XTalks

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. 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. The price of that prize is incalculable. Moderna’s COVID-19 Vaccine.