New WhitePapers information at Drug Development Technology New and updated information from WhitePapers listed on en-us New WhitePapers information at Drug Development Technology Drug Labeling Specialist on New Pregnancy Labeling Rules On June 30, 2015, the new pregnancy labeling rules for prescription drug labeling took effect, marking the demise of pregnancy categories (A, B, C, D, X), in use since 1979. Fri, 21 Jul 2017 09:20:00 GMT Sartorius Lab Instrument's Cubis® Balance Range Meets the Cleanability Requirements of the Pharmaceutical Industry Balances in Satorius Lan Instrument's Cubis® product range have been designed for the demanding pharmaceutical environment, which is regulated by good manufacturing practices (GMP) and good laboratory practices (GLP). Fri, 21 Jul 2017 09:20:00 GMT Gold Nanoparticle Applications and Characterization by Nanoparticle Tracking Analysis Gold nanoparticles are one of the most popular and extensively researched type of nanoparticle. Fri, 21 Jul 2017 09:19:00 GMT Characterisation Information of Critical Excipients for Sourcing Critical Raw Materials The increasing complexity of large molecule and cell-based therapeutics calls for an evolution in our understanding of the impurity and functional contributions of each formulation component. Fri, 21 Jul 2017 09:18:00 GMT ePAT Automated Lab Reactor Optimised for 24/7 Data Capture Systag Systems presents ePAT, a cost-effective device for automation in the laboratory. Fri, 21 Jul 2017 09:18:00 GMT The ImmunoPrecise Rapid Prime System Reduces the Immunization Stage of Hybridoma Production to 18 Days The ImmunoPrecise Rapid Prime System Reduces the Immunization Stage of Hybridoma Production to 18 Days Tue, 18 Jul 2017 09:09:00 GMT Case Study: Compaction Behaviour of Orally Dispersable Mini-Tablets This whitepaper describes a method for performing dynamic powder compaction analysis and for measuring tensile fracture strength of tablets. Tue, 18 Jul 2017 09:08:00 GMT Orthotopic and metastasis models for preclinical efficacy testing of novel cancer drugs Lack of efficacy is one of the major causes of attrition in the clinical development of new compounds to treat cancer. Tue, 18 Jul 2017 09:08:00 GMT Experienced Accessible Pharma Professionals and Global Regulatory Services PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals a… Tue, 18 Jul 2017 09:06:00 GMT An Analysis of Antibodies Using Multi-Detector SEC Methodology Antibodies' innate ability to direct their neutralisation attacks toward specific components in harmful agents has generated a large amount of interest within the pharmaceutical industry. Thu, 13 Jul 2017 15:57:00 GMT Application: Operating Reactor Systems for Process Research and Development In this case study, three reactor systems (FlexyCUBE 70ml, FlexyPAT 2l, and ChemTeacktor 25l) are operated on the same PC using application software FlexySys. Thu, 13 Jul 2017 15:56:00 GMT Benefits of Trehalose Products such as monoclonal antibodies (mAb), fusion proteins, peptides, vaccines, antibody drug conjugulates (ADC) and stem cells benefit from the stabilising effects of Trehalose. Thu, 13 Jul 2017 15:56:00 GMT Optimising Development Resources for Efficient Product Development Development departments suffer from a shortage of resources and are often overburdened with administration tasks. Thu, 13 Jul 2017 09:16:00 GMT From Gene to Finished Vial Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals, covering services from early development to finished vial. Thu, 13 Jul 2017 09:15:00 GMT Validated Metal Analysis Four commonly utilized carbohydrates for ptotein stabilization are Sucrose, Trehalose, Mannitol, and Maltose. Thu, 06 Jul 2017 15:58:00 GMT Processability Assessment of Crystal Habit-Modified Active Pharmaceutical Ingredients The efficiency of downstream processing of active pharmaceutical ingredients (API) can depend on their particulate properties, including size and shape. Thu, 06 Jul 2017 08:17:00 GMT An Analysis of Polymer Branching Using GPC / SEC Methodology Polymer branching has been proven to have a potentially considerable impact on many physical properties of synthesised polymers, such as the disruption of crystallinity and a possible increase in single chain density and chain entanglements. Sun, 02 Jul 2017 23:00:00 GMT Paradigm Shift Regarding API and Formulation Components This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limite… Thu, 29 Jun 2017 14:45:00 GMT Gamlen Study: Breaking Anisotropic Rod-Shaped Particles Gamlen presents a study conducted by V. Penkavova1, L. Kulaviak1, M.C. Ruzicka1, M. Puncochar, and P. Zamostny on the 'Beaking of Anisotropic Rod-Saped Particles'. Tue, 18 Apr 2017 23:00:00 GMT Softigel by Procaps Brochure Procaps is one of the world's largest softgel companies, specialising in the production and development of advanced gelatin-related technologies. Fri, 20 Jan 2017 16:50:00 GMT