Singota Solutions的动态

With 30 years of experience in the development and production of highly potent compounds, we are able to support your project from clinical through commercialization. Our API facilities can scale-up from laboratory-scale to 12,000 L vessels. The Oral Solid Dosage Drug Product manufacturing capabilities start with 100 g of blend and gradually increase according to the demand of your project, and we can even address #bioavailability-challenged APIs with enabling technologies such as spray drying, hot melt extrusion, micronization,and nanomilling. Our clinical and commercial injectable Drug Product facility can aseptically manufacture highly potent solutions in vials. This continuum of capabilities from #APIs to finished dosage Drug Products, including ready for-market packaging, labeling and serialization, allows you to either pick and choose your required services, or take advantage of our Integrated Supply Chain from development to commercialization. The level of integration is flexible and customizable, resulting in reduced complexity, de-risked supply chain and shorter lead-times. Read more about our services for Highly Potent & Oncology products:?https://lnkd.in/ekPYiREv #cordenpharma #cdmo #highlypotent #oncology #pharma #pharmaindustry #pharmaceutical #oralsoliddosage

Innovations in Prefilled Biologics, full article here:https://lnkd.in/eh8cAUir Prefilled products, particularly prefilled biologics, are a growing sector in the pharmaceutical industry. “Prefilled syringes and pens offer precise dosing, reducing the risk of errors during administration. They also eliminate the need for reconstitution, making them more convenient for patients and healthcare professionals,” explains Ward Smith, director of marketing and business development at Keystone Folding Box Company, a manufacturer of paperboard packaging. Prefilling also improves product/patient safety because less handling means less chance of contamination. Primary packaging developments include ready-to-use (RTU) containers and designs to address higher viscosity products, larger syringe volumes to meet the dosing requirements of longer-acting biologics, cryogenic storage and distribution, greater focus on self-administration and patient comfort, and container enhancements that minimize the risk of product/package interactions. “This minimized interaction risk ensures that the biologics maintain their efficacy and safety profiles,” says Van Ginneken. With sensitive substances and challenging environmental requirements, biologics place special demands on primary and secondary packaging. Many APIs are light-sensitive, and the large, complex molecules in many new molecular entities are sensitive to oxygen. Cell and gene therapies as well as messenger RNA (mRNA) substances must be stored and transported at extremely low temperatures. Thus, syringe development has focused on designs capable of withstanding low-temperature conditions without losing functionality or container closure integrity. One example, the TOPPAC freeze prefilled syringe from SCHOTT Pharma, is designed for drugs that require storage and transport at temperatures approaching -100 °C. Another option from SCHOTT Pharma, EVERIC freeze vials, are available in sizes from 2–30 mL and can be supplied RTU. Strength-optimized geometry, designed into the structure of the vials, reduces the risk of breakage (2). Thanks to Ward Smith Tom Van Ginneken Daniel Martinez Zubieta Corinna Endres Justin Schroeder Deborah Smook Keystone Folding Box Co. SCHOTT Pharma Stevanato Group Schreiner MediPharm L.P. PCI Pharma Services TurboFil Packaging Machines thanks also to Hallie Forcinio and Pharmaceutical Technology #pharmamanufacturing #aseptic #syringe #drugpackaging #biologics #bioprecessing #biopharmaceutical #ampoule #sut

Are you looking to accelerate your #drugproduct development? Leukocare's Advanced & SMART formulation development is optimal for all clinical phases. We combine scientific expertise with data science to improve the efficiency and success rate of your drug product development. Discover how we can provide you with a customized selection of #excipients for your #formulationdevelopment! https://lnkd.in/dzUiKbUK ----------- Leukocare AG is the leading innovator for drug product development and analytical services of small molecule parenterals and biologics such as #proteins, #viruses, #viralvectors, #exosomes, #mRNA, and many more. ? With over 20 years of drug product development experience and more than 150 analytical methods, we elevate our services to deliver faster and better results. #leukocare #drugsubstance #tpp #kineticmodeling #derisking #datascience #yearendoffer #costeffective #formulationdevelopment #CMC #particle #leukocare #highcon #developability #drugsubstance #aggregation #stabilitystudies #particlecharacterization #nongmp #biotech #biopharma #therapeutics #datascience #webinar #lyophilization #viralvectors #stabilization #biopharma

Another round of insightful webinars is approaching! Secure your Pharmaversity? spot now and get ready to dive into the future of pharma ??

New Article: Pens & Autoinjectors by William Welch, Executive Director of Market Development, shares his thoughts in the Drug Development & Delivery Special Report on Injection Devices. "Clients are thinking about their drug device strategy earlier in the development process. Many biophar-maceutical companies invest in research and development to not only en-hance device features and compatibility with a diverse range of large and small molecule drug products but also introduc-ing and evaluate them as viable dosage forms earlier in clinical trials through par-allel development strategies." Meeting the exponential growth in the development and use of autoinjectors, PCI Pharma Services continues to invest in device-agnostic, in-novative, scalable, injectable drug device final assembly, packaging, and la-beling technologies for autoinjectors, pre-filled syringes, PFS with needle safety device, pens, and on-body injector (OBIs).? "We have the scalability to handle the dynamic volumes of biopharmaceutical therapies, whether large or small, from early phase clinical trials through to com-mercial supply of niche personalized medicines to large, annual volume treatments." Read the complete Drug Development & Delivery special feature highlighting how the biopharmaceutical industry has made remarkable strides in developing patient-centric injectable devices that minimize pain, ensure precise drug delivery and reduce injection frequency, helping patients manage chronic diseases. https://lnkd.in/etNW9hVn #AdvancedDrugDelivery #PatientCentricity #CDMO #LetsTalkFuture

More than 80% of NCEs are poorly soluble compounds, making solubilization a critical factor in the formulation stage of the drug development process. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the development pipeline. Conventional formulation technologies can pose obstacles when it comes to compatibility with excipients and processing conditions used in manufacturing. Lipids used in drug development products have improved suitability and greater drug delivery efficiency. However, each API presents various complications for nanosizing, such as unwanted toxicity and side effects, making it crucial to find the appropriate formulation technologies and strategies to help prevent unwanted side effects in clinical studies and in post launch marketed drugs. Ascendia shares how a #CDMO partner with proven success in creating formulations to overcome poor solubility can take your product to market on schedule and within budget.

??Are you facing some challenges to stabilize your biological formulation? Seppic has developed an innovative solution for formulators facing challenges with solubilizing actives, emulsifying, and stabilizing O/W emulsions especially with complex and unstable large molecules. If you have not yet discovered Montanox? 20 HPB during @CPHI, stop by SEPPIC booth #6G22 to discuss your formulation needs with our experts.? #CPhI2024 #Pharmaindustry #pharma #biopharmaceutical #injectable #biologics #formulation #Montanox

????????-???????????? ?????????????????????? ???????? ???????????????? ????????????????????????: ?????????????? ???????????????????????? ?????? ???????????????????? ???????????????????????????? ???????????????????? Transdermal?administration remains an active research and development area as an alternative route for long-acting drug delivery. It avoids major drawbacks of conventional?oral?(gastrointestinal side effects, low drug bioavailability, and need for multiple dosing) or?parenteral?routes (invasiveness, pain, and psychological stress and bio-hazardous waste generated from needles), thereby increasing patient appeal and compliance. This review focuses on the current state of long-acting transdermal drug delivery, including adhesive patches,?microneedles, and molecularly imprinted polymeric systems.?Each subsection describes an approach including key considerations in formulation development, design, and process parameters with schematics. #pharmaceutical #microneedles #transdermal #drugdelivery

Emerging technologies like #artificialintelligence (#AI) and #predictivemodeling are reshaping the #pharmaceutical landscape, offering precise, data-driven insights that streamline #drugdevelopment and enhance #patientoutcomes. At Thermo Fisher Scientific, our patient-centric approach focuses on solutions that improve medication accessibility and efficacy. In a recent article, Sanjay Konagurthu, senior director of science and innovation for #drugproduct and #pharmaservices, shares how we leverage these technologies to tackle challenges like #solubility and #bioavailability early in the #oralsoliddose (#OSD) formulation process. Read the article on Contract Pharma to learn how these innovations not only accelerate the journey from #discovery to #delivery but also help life-saving therapies reach patients faster: https://spr.ly/6041srVlP

#Revolutionizing #505(b)(2) #Formulations: Discover the Cutting-Edge Capabilities of DiponCRS Labs In the fast-paced world of #pharmaceutical development, staying ahead of the curve requires innovation, speed, and precision. DiponCRS Labs, a division of Diponed Research International (DRI) Pvt Ltd, is at the forefront of this revolution, offering state-of-the-art 505(b)(2) formulation development services designed to meet the complex needs of today's #pharma clients. Accelerating Formulation #Development with #AI-Powered In #Silico Platforms At DiponCRS , we leverage advanced AI-based in silico platforms to develop #long-lasting, sustained-release #injectable formulations. Our AI-mediated approach significantly reduces the time required for formulation development—up to 50% faster than traditional methods. This cutting-edge technology enables us to predict and optimize formulations with unparalleled accuracy. Comprehensive #Wet Lab Validation Innovation doesn't stop at in silico design. Our expert team validates these formulations in our state-of-the-art wet lab, providing proof-of-concept development and conducting preclinical pharmacokinetic studies in both #rodent and #non-rodent models. This rigorous #validation process ensures that our formulations are not only theoretically sound but also practically viable. Advanced #Delivery Systems and #Platforms DiponCRS specializes in enhancing the performance of #drug delivery systems using a variety of innovative #technology platforms like -- #Liposomes and Their Combinations #Niosomes #Solid Lipid Nanoparticles #Lipid Coated Particles #Microspheres #Microemulsions #Exosomes These advanced delivery systems are designed to improve bioavailability, stability, and controlled release of active pharmaceutical ingredients (APIs), providing superior therapeutic outcomes. Tailored #Release Profiles We understand that different therapeutic needs require different release profiles. Our innovative platforms support : #Immediate Release Formulations #Zero Order Release Formulations #Delayed Release Formulations By tailoring the release profile to the specific needs of the treatment, we can enhance the efficacy and patient compliance of our formulations. Versatile #Dosage Forms Our capabilities extend across a wide range of dosage forms. We develop innovative formulations in various forms eg, #Liquids (#Syrups, #Lotions) #Suspensions #Emulsions #Injections #Semisolids (#Creams, #Gels, #Ointments) #End-to-End #505(b)(2) #Formulation #Development We offer comprehensive, end-to-end services for novel 505(b)(2) formulation development like-- #AI-Mediated In Silico Formulation Design #Development of Novel Formulations in the Wet Lab #Preclinical Pharmacokinetic Studies #Efficacy Studies #Toxicology Studies #IND Filing Partner with DiponCRS for your 505 (b)(2) research and development requirements!! [email protected], [email protected], [email protected] Sarmistha Deb Dr. Geetha Thanga Mariappan