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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

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Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues
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Published on: April 7, 2023

Protein pharmaceuticals: discovery and preclinical development.

Davinder S Gill1

  • 1Wyeth Research, Biological Technologies, 87 Cambridge Park Drive, Cambridge, Massachusetts 02140, USA. dgill@wyeth.com

Advances in Experimental Medicine and Biology
|January 5, 2010
PubMed
Summary
This summary is machine-generated.

This chapter explores protein-based biopharmaceuticals, detailing their discovery, development, and therapeutic applications. It highlights challenges and opportunities in optimizing these powerful drugs for diseases like cancer.

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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Area of Science:

  • Biopharmaceutical science
  • Molecular biology
  • Drug discovery

Background:

  • Proteins are vital molecules for cellular function; malfunctioning proteins cause disease.
  • Biopharmaceutical drugs target specific proteins to modulate cellular functions.
  • Biopharmaceuticals differ significantly from conventional medicines in origin, manufacturing, and delivery.

Purpose of the Study:

  • To describe methods for discovering, optimizing, and developing protein drugs.
  • To cover novel agents and next-generation protein therapeutics.
  • To discuss challenges and opportunities in biopharmaceutical development.

Main Methods:

  • Protein drug discovery and optimization techniques.
  • Cell culturing and purification processes for biopharmaceutical manufacturing.
  • Delivery methods for protein therapeutics (injection, infusion).

Main Results:

  • Biopharmaceuticals offer powerful and selective therapeutic applications, particularly in oncology and autoimmune diseases.
  • Current manufacturing processes can be time-consuming and costly.
  • Delivery limitations exist for many protein-based drugs.

Conclusions:

  • Protein drugs are crucial for treating complex diseases.
  • Advancements in discovery and development are essential for overcoming manufacturing and delivery challenges.
  • Future opportunities lie in novel agents and next-generation protein therapeutics.