PharmOptima?的动态

ENOTTA's work on therapeutic drug monitoring of monoclonal antibodies takes a major step forward! We’re thrilled to announce the publication of our first paper titled: “Therapeutic drug monitoring of monoclonal antibodies in chronic inflammatory diseases: A snapshot of laboratories and applications across?Europe” This research, conducted in collaboration with the European Cooperation in Science and Technology (COST) action ENOTTA members, sheds light on the current landscape of therapeutic drug monitoring (TDM) for monoclonal antibodies in chronic inflammatory diseases across Europe. Our study involved a comprehensive survey of laboratories, revealing valuable insights into: The prevalence of TDM for monoclonal antibodies The range of analytical methods employed by different labs Existing applications of TDM in clinical settings This data paves the way for harmonization of analytical approaches and furthers the field of TDM for monoclonal antibodies. You can access the paper https://lnkd.in/dzXVfsXf. A huge thank you to the entire team and our collaborators at ENOTTA for this significant achievement! #MonoclonalAntibodies #TDM #ChronicInflammation #Research #Europe #Collaboration Feel free to comment below or reach out to discuss the findings in more detail!

?????? ???????????? ???????????????????? ???????????????????? (????????) ???????????? ?????????? ???? ?????????????????? ???? ?????????? ?????? 309.47 ????. ???? ?????? ?????? ???? ?????? ???????????????? ???????????? ?????? ???? ???? ???????????????? ???? ???????? ???? ?????? ???????? ???? 7 %. ?????????? ???????? ?????? ?? ???????? ???????????????? ??????????????????????:? https://lnkd.in/eCaHp6Gz The Monoclonal Antibodies (mAbs) Market is experiencing significant growth due to their #widespread application in treating various diseases, particularly cancer, autoimmune disorders, and infectious diseases. Monoclonal antibodies, which are engineered immune system proteins designed to target specific antigens, have revolutionized the therapeutic landscape by offering highly specific and effective treatment options. Advances in #biotechnology and genetic engineering have enhanced the development and production of monoclonal antibodies, leading to the introduction of numerous innovative products in the market. The increasing incidence of chronic diseases and the #growing adoption of biologics are major factors driving the market's expansion. Moreover, substantial investments in research and development by pharmaceutical and biotechnology companies are further propelling the market. The development of next-generation monoclonal antibodies, including #bispecific antibodies and antibody-drug conjugates, is opening new avenues for more targeted and personalized therapies. Regulatory approvals and favorable #reimbursement policies are also supporting the market's growth. Additionally, the ongoing COVID-19 pandemic has highlighted the potential of monoclonal antibodies in combating infectious diseases, further boosting their demand. As the pipeline of monoclonal antibody therapies continues to expand and technological advancements enhance their efficacy and safety, the monoclonal antibodies market is poised for sustained #growth in the coming years. ?????????????????????? ??????????????????: 1. Novartis AG 2. Pfizer, Inc 3. Glaxosmithkline Mexico S.A. de C.V. 4. Amgen, Inc. 5. Merck & Co., Inc 6. Daiichi Sankyo US Company, Ltd. 7. Abbott 8. AstraZeneca 9. Eli Lilly and Company 10. Johnson & Johnson Services, Inc. #???????????????????????????????????????? #???????? #?????????????????????????? #?????????????????????????????? #?????????????????????????????????????? #???????????????????????????????????? #?????????????????? #?????????????????????????????? #???????????????????????????????????? #?????????????????????????????????? #?????????????????????????????????????????????? #???????????????????????????????????????? #???????????????????????????????? #???????????????????????????????????????????? #????????????????????????????????????????????

MRFF funds new national centre for mRNA medicines. The Commonwealth Government’s Medical Research Future Fund (MRFF) has invested $4 million into establishing Australia’s first National Centre for Biopharmaceutical Optimisation of mRNA Therapeutics (CORTx), being led by Monash University to optimise mRNA therapeutic candidates and advance them toward clinical trials. In recent years mRNA vaccines have transformed the way we fight infectious disease such as COVID-19, and now mRNA therapies are showing significant promise to treat a wide range of diseases including cancer, infectious diseases, auto-immune and metabolic diseases. The new national facility will focus on a critical step in the development process for mRNA medicines, which is to evaluate delivery and biodistribution in the body, informing the plausibility of the candidate to progress toward human studies. This information is critical for maximising the potency, safety and manufacturability of mRNA medicines. Read more: https://hubs.la/Q02Lpb1Z0 #mRNAtherapeutics #MRFF #AustralianScience #NationalCentre #Biopharmaceutical #DrugDevelopment #CancerResearch #InfectiousDisease #AutoimmuneDisease #MetabolicDisease #MonashUniversity #Collaboration #Research #Innovation #Healthcare

Nature Biotechnology offers their take on 2023 US Food and Drug Administration approvals. Key message is that FDA approved a record-breaking 71 new medicines in 2023, which may help assuage concerns of a more restrictive regulator following?2022’s sub-40 approval tally?and signal a back-to-business FDA following the official end of the US COVID-19 public health emergency. We would quibble a bit with the presentation of data in Fig 1, which groups biologics approved by CDER (e.g., antibody therapeutics) with those approved by CBER (e.g., vaccines, gene therapy). However, Table 1 shows that ~1/3 of CDER approvals in 2023 were antibody therapeutics. #mabs https://lnkd.in/gvVkbgiX

?????? ???? ?????????????? ?? ???????????? ????????? Developing a cancer drug involves a complex and highly regulated process that typically spans several years. ????????’?? ?? ?????????? ???????????????? ???? ?????? ?????????? ????????????????: ?? ?????????????????? ?????? ????????????????: Scientists conduct basic research to understand cancer biology and identify potential targets for drugs. This often involves experiments in cell cultures and animal models. ?????????????????? ????????????????????????????: Once a target is identified, researchers screen thousands to millions of compounds to find those that affect the target in the desired way. ???????????????????????? ??????????????: Compounds that show promise are then tested in laboratory and animal studies to determine their safety and efficacy. ?????????????????? ????????????: If a compound is found to be safe and effective in preclinical tests, it moves into clinical trials, which are conducted in three phases (I, II, and III) to test the drug's safety, dosage, efficacy, and side effects in humans. ?????????????????????? ????????????: If clinical trials demonstrate that the drug is safe and effective, the manufacturer submits a New Drug Application (NDA) to regulatory bodies like the U.S. Food and Drug Administration (FDA). The agency reviews the drug's research and trial results before approving it for use. ???????????????????????????? ?????? ??????????????????: Once approved, the drug can be manufactured on a larger scale and marketed to healthcare providers and patients. ??????????-?????????????????? ????????????????????????: Even after a drug is on the market, it continues to be monitored for any long-term or rare side effects. There is a massive collaboration among scientists, doctors, regulatory experts, and often many other stakeholders to accomplish this process. The process also involves stringent adherence to ethical standards and regulatory guidelines. #cancer #clinicaltrial #pharmaceuticalindustry #bioinformatics #oncology #drugdiscovery --------------------------------------------------------- I'm ???? ?????????????????????? ????????, ??????. Did you find this post helpful? Repost ?? & Follow for more tips on healthcare innovations! ---------------------------------------------------------

Very insightful and excellent to read Review from BioNTech. “Unwanted byproducts, if not removed, could be formulated together with the full-length mRNA and cause an immune response in cells by activating host pattern recognition receptors. In this review, It is summarize the potential types of IVT byproducts, their known biological activity, and how they can impact the efficacy and safety of mRNA therapeutics. In addition, it is briefly overview non-nucleotide-based contaminants such as RNases, endotoxin and metal ions that, when present in the IVT reaction, can also influence the activity of mRNA-based drugs. It is also further discuss current approaches aimed at adjusting the IVT reaction conditions or improving mRNA purification to achieve optimal performance for medical applications” Nice insights!

????????????????????????????????????: ?????????????? ?????????????? ???????????? ??? | IndustryARC? Biopharmaceuticals Market Size is forecast to reach?$655631 Million by 2030,?at a?7.20%?during forecast period?2024-2030. ?????? ????????: https://lnkd.in/g8PPyeNs #Biopharmaceuticals are #medical products derived from living organisms, including proteins, antibodies, and nucleic acids, designed to treat various diseases and conditions. They leverage #biological processes to create targeted therapies that are often more effective and specific than traditional pharmaceuticals. Common applications include treatments for cancer, autoimmune disorders, and infectious diseases. Biopharmaceuticals are typically produced using advanced techniques like recombinant #DNA technology and monoclonal antibody production. As a rapidly growing field, biopharmaceuticals represent a significant advancement in personalized medicine, aiming to improve patient outcomes and enhance quality of life through innovative therapies tailored to individual needs. Biopharmaceuticals play a crucial role in modern medicine, providing targeted treatments for a wide range of diseases. One of their primary uses is in oncology, where biologics like monoclonal antibodies are employed to specifically target cancer cells, reducing damage to healthy tissue and enhancing treatment efficacy. They also address autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis, by modulating the immune system’s response. In the field of infectious diseases, biopharmaceuticals include vaccines and therapeutics that can effectively combat viruses, bacteria, and other pathogens. For example, mRNA vaccines have emerged as a groundbreaking approach to prevent diseases like COVID-19. ???????????????? ????????????: https://lnkd.in/ginVx8KR The personalized medicine approach enabled by biopharmaceuticals allows treatments to be tailored to individual genetic profiles, improving efficacy and reducing side effects. Overall, biopharmaceuticals are integral to advancing #healthcare, enhancing treatment options, and improving patient outcomes across various medical disciplines. ?????? ?????? ??????????????: Genesis Healthcare | Jazz Pharmaceuticals | Sino Biopharmaceutical Limited Incyte | Draegerwerk AG & Co KGaA | ONO PHARMA USA? | athenahealth | Octapharma | Ipsen | Chiesi USA, Inc. | SHIMADZU CORPORATION | Hengrui USA Medicine | AdaptHealth | Dexcom | Kyowa Kirin, Inc.- U.S. Kirin | Pierre Fabre Laboratories | Aurobindo Pharma USA, Inc. | Dr. Reddy's Laboratories's | Shionogi Inc. (U.S.)

If you missed the free live webinar on mRNA Quality Assessment and USP Guidelines, here's your chance to watch it on demand! With over 150 mRNA vaccines in development, including therapeutic applications in oncology, cardiovascular, and genetic diseases, forecasts predict a high level of growth in products using this drug manufacturing platform. USP has worked with vaccine experts to generate draft guidelines for analytical procedures for mRNA vaccine quality and solicited feedback from stakeholders to update and evolve the guidelines. In this presentation, John Cipollo, Ph.D. Team Lead and Senior Principal Scientist at US Pharmacopeia, and Khaled Yamout, Senior Director at TriLink BioTechnologies, part of Maravai LifeSciences , will provide an overview of the updated guidelines and plans for further assessment and qualification of analytical methods presented therein. Join the conversation on #mRNA #Vaccines #Quality #AnalyticalMethods #covid19 #Oncology #Cardiovascular #Genetic #Diseases #Biopharmawebinars #Biotech #Biologics #Biopharma. Watch the webinar here: https://lnkd.in/ew5jc6qJ #mRNA #Vaccines #Quality #AnalyticalMethods #covid19 #Oncology #Cardiovascular #Genetic #Diseases #Biopharmawebinars #Biotech #Biologics #Biopharma

What are RNA interference drugs? First discovered in 1998, RNA interference gave drugmakers a tool to silence genes that encode disease-causing proteins. In the nearly three decades since, Alnylam has used that tool to develop five approved medicines for a range of rare and common diseases. (A sixth, from Novo Nordisk-owned Dicerna Pharmaceuticals, is also approved.) Currently, pharma companies are looking for drugs known as small interfering RNA, or siRNA, drugs which can mute messenger RNA and thereby prevent problematic proteins from being made by a cell. This technique is being now utilized to further look to specific organs like kidney where filtration and excretion of drugs can be trace. Targeting in specific organs like kidney will offer insights into diabetes and hypertension https://lnkd.in/gQjcZ5ZJ

Designing and generating #antibodies can be a complex and challenging process. At Abzena, we offer comprehensive antibody discovery and engineering services that streamline and de-risk this critical phase, moving biologics from concept to candidate selection with precision and expertise. Leveraging expert assessments of target molecules, immunization strategies and antibody screening cascades, we generate robust data that ensures optimal antibody discovery and supports the selection of the best antibody candidate for your drug development program.?Our discovery methods are focused on ensuring high affinity antibodies and include flow cytometry, SPR analysis, in vitro assays, epitope binning and hybridoma sequencing. Learn more about how our comprehensive suite of discovery services can streamline your antibody program from concept to lead candidate selection today: https://lnkd.in/e8QMNi2P #Biologics #DrugDiscovery #CRO #CDMO #drugdevelopment