Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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![Warning-Explanation-Point-iStock-1081925728]( "Telltale Signs You’re With The Wrong CDMO")
Telltale Signs You’re With The Wrong CDMOIs your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.
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![A Single-Vendor CDMO Eases Communication Flow]( "How To Pick The Right CDMO For Late-Phase Clinical Trials")
How To Pick The Right CDMO For Late-Phase Clinical TrialsFor pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.
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![Bioprocess machine 450x300]( "What You Need To Know About Process Characterization And Validation For Biologic Processes")
What You Need To Know About Process Characterization And Validation For Biologic ProcessesProcess characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.
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![Antibodies]( "The Path To High-Quality Immunoassay Reagents")
The Path To High-Quality Immunoassay ReagentsThere is a continued demand for novel, fit-for-purpose immunoassays. Despite the challenges, it’s important for assay developers to streamline the selection and potential modification of critical reagents to get their tests to market quicker.
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![protein molecule]( "Enhanced Host Cell Protein Analysis In Biologics Manufacturing")
Enhanced Host Cell Protein Analysis In Biologics ManufacturingiEnzyme-Linked Immunosorbent Assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates an enhanced anti-host cell protein antibody coverage analysis method solution.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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![Colored Tablets]( "An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions")
An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid DispersionsThis poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).
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![Blue cells 450x300]( "Scale-Up Of CHO Cell Fed-Batch Cultures In HyClone ActiPro Medium Supplemented With Cell Boost 7a And 7b")
Scale-Up Of CHO Cell Fed-Batch Cultures In HyClone ActiPro Medium Supplemented With Cell Boost 7a And 7bThis note compares cell growth and recombinant protein production of multiple Chinese hamster ovary cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.
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![CHO cell culture]( "Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures")
Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch CulturesThis app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.
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![GE i zZBdtQg]( "Optimizing Cell Culture Media To Increase Cell Culture Titer With Maintained Protein Quality")
Optimizing Cell Culture Media To Increase Cell Culture Titer With Maintained Protein QualityWhen evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiments (DoE) and empirical approach. Here is an example of how to do it.
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![Pharma Manager Blockchain supply chain 450x300]( "Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply Chain")
Meet Aggressive Timelines By Simplifying Your Drug Delivery Supply ChainTo meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route for drug substance, drug product, and clinical trial packaging needs.
FORMULATION DEVELOPMENT PRODUCTS & SERVICES
The Hitachi Koki model himac CR22N High-Speed Refrigerated Centrifuge offers reliable performance with a maximum RCF of 55,200xg and capacity of 6L for bottles, tubes, or microplates. Patented features such as the Automatic Rotor Identification and Rotor Cover Detector make the CR22N the ideal separation tool for multiple research applications involving DNA, RNA, viruses, proteins, and more.
The CP100WX is a general-purpose Ultracentrifuge with outstanding performance up to 100,000 rpm assisting in a wide range of separation protocols in involving proteins, DNA, RNA, metal nano-colloids, and more. Reliable and efficient the Hitachi CP100WX features a Rotor Life Management (RLM) system to automatically maintain rotor logging history maximizing rotor life.
NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).
The Jet Feeder is a multi purpose system for feeding powders into liquid and for low shear mixing. It is the perfect unit to use on those products that are sensitive to shear. ILC Dover completed a successful test at a pharmaceutical facility for mixing starch into solution for a tableting process. The system is cGMP, easy to clean or CIP, and will work in single pass processes or recirculating processes. JetSolutions is an ILC Dover company and is the manufacturer of the Jet Feeder.
NuAire offers ventilated and refrigerated micro-centrifuges ideal for high and low speed applications for small sample volumes.
Nanoparticle size analyzer with zeta potential measurements.
The new Zetasizer Ultra is our most advanced system for the measurement of particle and molecular size, particle charge and particle concentration, and represents the most intelligent and flexible instrument in the Zetasizer range.
Nanoparticle size analyzer with zeta potential measurements.
The Zetasizer Pro is a robust and versatile system for the measurement of particle and molecular size and electrophoretic mobility and zeta potential of nanoparticles.
NuAire benchtop centrifuges offer mono and multi functionality, refrigerated and non-refrigerated models. Technical innovations optimize productivity in your laboratory work to improve results, save time, while providing a greater relative centrifugal force (RFC).
FORMULATION DEVELOPMENT SOLUTIONS
- Container Closure Integrity Testing
- Small Molecule API Brochure
- Light Path™ Custom Material Supply: Mammalian And Microbial Custom Services For Protein Production
- Almac - A Unique Culture Delivering Exceptional Solutions
- Microcentrifuges: Ideal For Small Sample Volumes
- Lonza: CDMO Offerings Span Complete Biopharma Product Lifecycle
- Micro Ultracentrifuges
- Integrated Biotech Services: From Strain To Commercial Product
- Particle Analyzer: Zetasizer Pro And Zetasizer Ultra
- Surfactant Analysis Services
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- HOLLOWAY AMERICA Expands Vessel-Fabrication Capacity With New Production Building
- Meissner Manufactures Single-Use Systems In Castlebar, Ireland
- Biopharmaceutical Manufacturers To Be Given Support In Optimizing Cell Culture Media Filtration
- Romaco Releases New Kilian S 710 Prime Double-Sided Rotary Tablet Press
- Blow-Fill-Seal Packaging Manufacturer Rommelag Names New Managing Director
- FDA Lists Beckman Coulter Life Sciences RNA Extraction Kit For Use In EUA-Authorized COVID-19 Test
- Peli BioThermal Expands Global Rental Network In Incheon, South Korea
- POINT Biopharma To Establish First Manufacturing Facility In Indianapolis
- Wuxi Biologics Announces Plans For New Manufacturing Facility In Worchester MA
- Mettler-Toledo Announces Product Inspection Virtual Tradeshow June 1-5