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Pharmaceutical Bio Articles & Analysis: Older
11 articles found
Ion chromatography (IC) is an analytical technique used to separate and quantify ionic and polar analytes. IC has become widely accepted by the pharma industry and regulatory bodies for an expanded range of applications like water quality and chemical analysis. It has qualified in recent years to analyze pharmaceuticals. The United States Pharmacopeia-National Formulary (USP-NF, US Pharmacopeia ...
ByB&W Tek
Antibody drug glycosylation analysis is a critical bio-pharmaceutical analysis method, specifically used to evaluate and monitor the glycan structures on antibody drugs. Glycosylation analysis is crucial for ensuring the safety, efficacy, and consistency of drugs, as the structure and composition of glycans directly influence the bioactivity and pharmacokinetic properties of antibody ...
Harnessing the power of cell biology, scientists across the globe are perpetually invested in the pursuit of understanding the complexities of cellular mechanisms and their adaptability. One such venture is the creation of Inducible Expression Stable Cell Line (IESCL) development. IESCL signifies a consolidated methodology designed to explore the potentialities of modulated gene expression. This ...
Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross functional teams like R&D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so on. At every phase of development process, ...
ByDDi LLC
The Five Factors Research organizations are under pressure to cut costs while maintaining or increasing throughput. To improve their operations, many laboratories are considering investments in data management or support and automation systems like ELNs, LIMS or Robotics/HTS. Whatever the change that is introduced, there are many pitfalls on the way to delivery, roll-out and successful ...
Nanobiotechnology refers to the ability to create and manipulate biological and bio-chemical materials, devices, and systems at atomic and molecular levels. Nano delivery systems hold great potential to overcome some of the obstacles in bio-pharmaceutical production, such as water soluble/insoluble pharmaceutical drugs and cosmetic ingredients, risks of toxicity, increasing bio-active efficacy, ...
The basic thesis of this paper is that the R&D sector of the new medicines' business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to ...
The commercial use of embryonic or adult stem cells is still in its infancy. Most young firms concentrated on the generation and storage of stem cells, the development of tissues and related equipment. But the perspectives of therapeutic use of stem cells attract a lot of political and commercial attention to possible new strategic markets opening up new fields besides incumbent ...
Animal experimentation has provoked debate since its establishment, in the modern sense. Recent years have seen a culmination of the debate. Animal rights campaigners have used direct action in order to stop experimentation, and both the industry and the government have replied through toughening security and implementing legislative changes. The main issue is ethics: can we, and on what grounds, ...
Due to its influence on changes of research paradigms and development of hitherto unknown applications, commercialisation of biotechnological knowledge causes new challenges for regulatory procedures in pharmaceutical markets. By affecting time and probability of successful commercialisation, private and public institutions systems of risk management also influence the structure of financing ...
Process characterisation is an important aspect of any validation program. This article presents arguments on how process characterisation should be integrated to the process of Research & Development (R&D) itself of a biopharmaceutical product. This makes the work of technical transference and validation easier in the last stages. Although the application of this methodology is time consuming ...