Research and development - Articles
As the field of antibody-drug conjugation chemistry has advanced, the use of linkers to impart "drugability" has also been growing. Biopharma PEG leapts at the opportunity to develp various high purity PEG derivatives used as ADC linkers. Antibody–drug conjugates (ADCs) or immunoconjugates have shown to offer the unique benefits of a targeted therapeutic strategy combined with the best features of both therapeutic monoclonal antibodies (mAb) and potent small-molecule cytotoxic drugs through a linke…
Historically, the way patients have been treated for diseases has been centred around our understanding of a dominant version of a disease as it occurs in the average human. The ailment is identified, a treatment path is offered, and drugs are prescribed. The effectiveness of this treatment, however, can vary due to a range of factors. The patient might have a particular variation of a disease, or a conflicting condition, or their biological makeup means cert…
The major preclinical phases of peptide drug discovery encompass initial target identification and validation, hit identification, high throughput screening, lead optimization, etc. Among them, hit identification is one of the most critical steps in identifying peptides that can interact with well-validated targets. Hit identification (HI) follows the process of target validation, in which the compound screening assays are developed. The main goal of the HI process is to apply the most suitable hit finding approaches…
A comprehensive, approved master data source is increasingly vital to support a whole range of activities, whether submission and compliance related, or supporting internal analytics and management reporting. Without complete confidence in a defined quality, integrity, currency and completeness of data, however, there are two main risks to the business functions. One is that they will fall foul of the authorities, providing inaccurate or out-of-date information, and as a…
Pharmaceutical excipients refer to the substances used in the production and formulation of medicines. They perform multiple functions in pharmaceutical preparations and are likely to affect the quality, safety and effectiveness of drugs. Pharmaceutical excipients can be classified into natural, semi-synthetic and fully synthetic compounds according to their sources. And based on their use, excipients can be divided into diluents, binders, disintegrants, lubricants, glidants and anti-caking agents, wetting agents and solubilizers. Among all varieties of excipients, how to select the most appropriate ones for a specific drug formulation project? The guidelines be…
For companies to improve their performance, they have to understand their failures. But deep understanding requires more than just making a bit more effort – it needs a change of mindset where failures are not seen as problems but as opportunities for improvement. Establishing a Corrective Action Preventive Action (CAPA) programme benefits a company in many different ways. A well-designed CAPA programme can enhance and improve a company’s relationships with its clients and vendors, at the same time as cutting costs and reduci…
Peptides with low molecular weight have been known to be less allergenic and the diverse physiological roles of peptides make them suitable candidates for the development of therapeutic agents. Peptide drugs are widely used in the prevention, diagnosis, and treatment of diseases such as cancer, diabetes, and AIDS. However, t…
Peptide plays a key role in basic biochemical and physiological processes, and it is essential to many aspects of biomedical research, especially when the pharmaceutical industry continues to apply new drug candidates in the biological field. Therefore, rapid, efficient, and reliable methodology for the chemical synthesis of peptide drugs is of utmost interest in chemical biology research. In gener…
Protein structure analysis is one of the core contents of protein engineering. It mainly collects a large amount of protein molecular structure information in order to establish a database of the relationship between structure and function, thereby laying…
It takes at least ten years for a new medicine to reach market, with clinical trials alone taking up to seven years. But drug developers, particularly those developing vaccines, have had to work much quicker in recent times. Could industry maintain this momentum, and develop pharmaceutical products faster? Here, Dave Walsha, sales m…
The pathogen causing New Coronavirus pneumonia is a beta genus coronavirus called SARS-CoV-2, which is an RNA virus. After entering cells through the human ACE2 receptor, SARS-CoV-2 translates and expresses the polyprotein pp1a/pp1ab, which is then hydrolyzed by Mpro or 3CLpro or nsp5 to release various nonstructural proteins that are important for virus replication, thus inhibiting the activity of 3CL protease and blocking virus replication. In order to obtain non-covalent 3CL protease inhibitors as clinical candidates quickly, Shionogi performed docking-based virtual screening and biological screening of its in-…
“I like the excitement of not knowing what’s going to happen and I think I thrive on it.” For the first interview in our Human Strategy Series, the team recently spoke with Dr Jackie Ameri, CEO of Pancryos, who benefited from our Leadership Assessment service as part of the partnership between Coulter P…
Protein phosphorylation is one of the most important post-translational modifications of proteins, and phosphorylation occurs in about 1/3 of all proteins in eukaryotic cells. Catalyzed by protein kinases, phosphate groups are transferred from the donor molecule to the side chains of amino acids containing hydroxyl groups…
Cytokines are classified according to their different roles in the inflammatory response: pro-inflammatory cytokines and anti-inflammatory cytokines. Pro-inflammatory Cytokines Interleukin-1 (IL-1) IL-1 is a proinflammatory cytokine that activates a variety of immune and inflammatory cells and is secreted mainly by monocytes/macrophages, neutrophils and endothelial cells. IL-1 consists of two genetically encoded peptide molecules, IL-1α and IL-1β, both with a molecular mass of about 17 ku, the former being secreted, while the latter is mostly cell bound. IL-1β stimulates the production of other CK and inflammatory transmitters th…
What are exosomes? Exosomes, a tiny membrane vesicle with a lipid bilayer structure, are secreted by most cells and are approximately 40-200 nm in diameter. exosom…
Post-translational modification (PTM) is the covalent and generally enzymatic modification of proteins following protein biosynthesis. Proteins are synthesized by ribosomes that translate mRNA into polypeptide chains and then undergo PTM to form the mature protein product. After the protein is compounded, 20 different amino acids participate in protein PTM, such as protein phosphorylation, protein acetylation, as well as protein methylation, which play a significant role in almost all biological processes. Therefore, the synthesis of post-translationally modified peptid…
The Microbiome Sequencing in Cancer Research A growing body of evidence now suggests that human microbial dysbiosis has a crucial role in cancer development and progression. Unlikely earlier studies relying on culturing bacteria from the tissue of cancer, high-throughput sequencing methods have enabled genotyping the microbi…
Biomarkers are defined as measurable biological characteristics that associate with normal or pathological conditions. They possess clinical relevance, including diagnostic, prognostic, and predictive values. RNA, not only an essential part of central dogma, is certainly a relatively untapped resource for biomarker discovery of various diseases. Cumulating data show that RNA molecules, including mRNAs, lncRNAs, miRNAs, siRNAs, piRNAs, snoRNA…
The packaging materials used for pharmaceutical tablets are in direct contact with the pharmaceuticals. Therefore, as a pharmaceutical manufacturer, when selecting packaging materials, it is necessary to understand some properties and characteristics of packaging materials and containers, to ensure the efficacy and quality of medicines. What are the common pharmaceutical packaging materials? Glass: Glass has the advantages of being moisture-proof, easy to s…
On February 16, 2022, the data on Paxlovid previously published by Pfizer and submitted to the FDA were published in the New England Journal of Medicine (NEJM). This NEJM article published viral load data that Paxlovid reduced viral load by 0.868 log10 compared to controls for 5 days of treatment, which equates to a remarkable 7.38-fold reduction in viral load. This pivotal study (NCT04960202) enrolled 2,246 patients with COVID-19, 1,120 received Paxlovid and 1,126 received placebo. Interim analysis showed that 28 days after receiving treatment, Paxlovid reduced the risk of hospitalization and death by 89.1% (p<0.001). Applying the final results of the IT…