Products, services, reviews and techniques used in pharmaceutical product scale-up, formulation, shipping and manufacturing processes.
PCSK9 mice were created utilizing a full-length human PSK9 cDNA with a C-terminal V5 tag expressed under the transcriptional control of a composite human albumin promoter containing a 235 bp SV40 enhancer and a 213 bp albumin promoter element. A chimeric intron was inserted between the promoter and PCSK 9 cDNA to enhance expression. The expression cassette was flanked by a 1.2 kb insulator sequence from the chicken beta-globu…
Okamoto, Kyoto School of Medicine, 1963, from outbred Wistar Kyoto male with marked elevation of blood pressure mated to female with slightly elevated blood pressure. Brother x sister mating with continued selection for spontaneous hypertension was then started. To NIH in 1966 from Okamoto at F13. To Charles River from NIH in 1973 at F32.Model Properties: Coat Color: White (albino) MHC Haplotype: RT1k Ideal For: genet…
As study protocols become more complex, so too does the need to have an in vivo model that specifically fits your study design. Charles River offers customized animal preconditioning that is tailored to your research requirements. Whether you need an animal that has been surgically altered, fed a specialized diet or reared to a specific age, we can deliver study-ready animals right to your door, when and where you need them.C…
Envirotainer presents the latest addition to our portfolio of active temperature-controlled air cargo containers. Designed for the most extreme requirements of the healthcare industry, the RAP e2 container maintains product temperatures between ±0 and +25°C in nearly any ambient condition appearing along shipping routes globally.The container handles any chosen set temperature, including the most commonly required in the cold…
Drawing on the benefits of the shape and size of the Envirotainer dry-ice container, the RKN e1 uses a different technology: compressor cooling and electric heating. Designed for the extreme requirements of the healthcare industry, the RKN e1 container maintains product temperatures in the +2 to +8°C range, in the controlled room temperature (+15 to +25 °C) range or at any chosen set temperature within the operating range of…
Get started in healthcare transports or share knowledge and become better at what you do. A dedicated team of specialists is there to provide you with solutions and services that strengthen and extend your business. Envirotainer provides valuable additional services, including laboratory testing, qualification and validation support, data collection and reporting services, and the Qualified Envirotainer Program (QEP)…
Your product development plans deserve the best integrated program of research services available - so choose Covance. With pressure to substantially increase numbers of trial participants, increased scrutiny on product safety and stringent regulatory controls throughout the world, Covance is ready to partner and bring to the fore the expertise, resources and insight required to guide you through the complex and challenging c…
Total flexibility. Covance's Clinical Development services are customized to your specific needs. The stakes are high as your drug enters clinical development in Phase II-III. With your drug’s future on the line, you need to navigate a global maze of patient populations, practice patterns and regulatory requirements, often also languages and time zones, before the goal of regulatory approval is in sight. It’s challenging and…
Superior Regulatory Service Helps Transform Your Clinical Trials. Strong regulatory strategies are pivotal in getting products to market. While many countries’ drug regulations are similar, there are still significant differences. These similarities and differences are the basis of a global regulatory strategy that encompasses the needs of all regions. Serving you where you need to be, our Regulatory Affairs teams are located…
A mutation occurred in a colony of outbred Zucker rats in the laboratory of Dr. Walter Shaw at Eli Lilly Research Laboratories in Indianapolis, IN in 1974–75. Part of this colony containing the mutation was moved to Indiana University Medical School (IUMS), to the laboratory of Dr. Julia Clark in 1977. Several groups of animals with diabetic lineage were identified and rederived in 1981. Inbreeding of selected pairs from this…
ProBioGen holds a manufacturing authorization for GMP (Good manufacturing practice) compliant manufacturing and batch release of biotechnological drug substances and fulfills all present regulatory requirements by EMA and FDA. GMP Manufacturing Services include: Manufacturing of pre-clinical and GMP grade material Disposable bioreactor Technology, stirred tank bioreactors - Decreased risk of cross contamination - Reduce…
Stable, High-Yield Mammalian Producer Cell Lines. ProBioGen's in-house cell line engineering platform enables them to provide our clients with pharmaceutical producer clones that exceed the limits of the current industrial standard, while still supporting a royalty-free fee-for-service business model.ProBioGen have built a fully integrated technology platform that encompasses the key actuating variables: Host Cell Line, Vecto…
Developed by Dr. Lewis from Wistar stock in the early 1950s. To Charles River from Tulane in 1970 at F34. Model Properties: Coat Color: White (albino) MHC Haplotype: RT1 Ideal For: transplantation research, induced arthritis/inflammation, experimental allergic encephalitis, STZ-induced diabetes Strain Code: 004
The Spontaneously Hypertensive Stroke Prone Rat (SHRSP)was isolated from Wistar-Kyoto rats by Okamoto and Aoki in 1963. The A3 subline was transferred to the National Institutes of Health in 1975 from Yamori at generation F36. To Charles River in 2002. Model Properties: Coat Color: White (albino) Ideal For: stroke, ADHD model, nephropathy, hypertension, osteoporosis Strain Code: 324
Serving preclinical research laboratories in over 150 countries and facilitating your preclinical research quickly and efficiently. As experts in time and temperature critical shipments for over 30 years, Marken understands the importance of providing reliable supply chain support throughout the drug development process, including early R&D activities and preclinical safety testing.Marken provide global shipping solutions for…
The new Grande Fleur expands the product offering in the dynamic temperature control range. The Grande Fleur together with the Petite Fleur are two small Tangos and are the entry level into the world of Unistat technology. The compact dimensions and unique thermodynamics of the Grande Fleur mean it is ideally suited for high precision temperature control of research reactors. The Grande Fleur offers all of the great performan…
Seal and individualize 96- and 384-format 2D-barcoded storage tubes in a single process using the Thermo Scientific™ SampleSeal™ Heat Sealer. The foil-sealed tubes can be reliably stored at temperatures from -196° to +25°C, and easily pierced with manual or automated pipette tips, supporting compatibility across standalone or integrated storage applications. The SampleSeal creates single access samples which eliminate thaw an…
Our Flipper® racks present colorful solutions and space saving utility for tubes ranging in size from 0.2mL all the way up to 50mL. Available in different configurations to meet laboratory needs.
ProVance™ columns are a high-performance disposable chromatography solution to help meet the growing demand for downstream purification. Until now, there has not been a cost-effective Protein A chromatography option for single-use manufacturing facilities. ProVance™ columns combine Grace proprietary incompressible silica with cost-effective Protein A and disposable column hardware.Grace is the world's largest supplier of spec…
Ziath’s range of CryzoTraq™ cryogenic vials are designed for cryogenic storage of biological specimens at temperatures as low as -196°C. The range features outstanding leak resistance with a LDPE compression ring moulded into the screw cap. For information on the tests performed to ensure leak-free tubes, download our white paper. The tubes are available in 2ml or 5ml volumes with an internally or externally threaded cap. All…
The Ziath Linear Rack Scanner Version 2 is for use with the DataPaq™ Express, Deep Focus, High Speed and Multi-Rack Scanners. It is simply attached to the scanner using a bracket with a magnetic place holder. No assembly of the linear scanner is required, in addition the DataPaq™ Linear Rack Barcode Scanner is very simple to attach to existing 2D scanners, and offers easy installation. It can be attached to any side of the Da…
An ideal choice for drug delivery. Human albumin is ideally suited as a half-life extension approach for protein drugs. It is a natural, non-immunogenic plasma carrier protein which is extremely stable, highly soluble and large enough to avoid renal clearance. It is also widely accepted that albumin is recycled in the body, due to its interaction with its receptor, known as the neonatal Fc receptor (FcRn). FcRn is present on…
Recombinant albumin developed as an excipient for use in drug delivery and formulation. Recombumin Prime is the world's first and only supply of commercial, animal-free, recombinant human albumin, approved for use in the manufacture of human therapeutics.Used in the manufacture of the FDA and EMEA approved MMR™ II childhood vaccine from Merck and Co., Recombumin Prime USP-NF* is also being evaluated as an excipient, or ingred…
Derived from our proprietary S. cerevisiae yeast expression technology Recombumin Alpha USP-NF* has been developed to deliver quality and unprecedented performance benefits in our customers' applications including drug and vaccine manufacture, device coating, IVF media, specialized cell culture and cell therapy applications. Benefits: Animal-free Secure supply in large volume quantities cGMP for regulatory-compliance…
ambr15™ mimics the characteristics of classical bioreactors at microscale (10-15ml), by using cost effective, disposable micro bioreactors, controlled by an automated workstation. ambr15 enables the rapid evaluation of multiple bioreactor cultures at microscale, increasing productivity in cell line development with significant savings on materials and labour. ambr15 is widely used by major Pharma and biologics companies, acade…
