Authors
Latest:
Model-Based Simulation: Getting Comfortable with RandomnessTwenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.
Latest:
Improving Nanoprecipitation ControlThe performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.
Latest:
A QbD Approach to Shorten Tablet Development TimeTableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.
Latest:
Characterizing a Bioprocess with Advanced Data AnalyticsAdvanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.
Latest:
Characterizing a Bioprocess with Advanced Data AnalyticsAdvanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.
Latest:
Automating Pharmaceutical Packaging InspectionMachine vision and optical character recognition technologies enhance inspection of packages and labels.
Latest:
Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Latest:
Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
Latest:
Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Latest:
Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
Latest:
Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
Latest:
Good Quality Agreements Support Compliance with CGMPDrug manufacturers can improve use of quality agreements in contract manufacturing.
Latest:
Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Latest:
Dry Particle Coating—A Unique Solution for Pharmaceutical FormulationAston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Latest:
High Throughput Screening of ExcipientsThe author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.
Latest:
Removing the Bitter Taste from Drug DevelopmentIntegration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.
Latest:
Transition From Clinical to Commercial Supply Chain-Regulatory Starting MaterialsThe authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
Latest:
Transition From Clinical to Commercial Supply Chain-Regulatory Starting MaterialsThe authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
Latest:
Why Good Records Management Is KeyThe past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be signing more preferred partner deals, such as Pfizer teaming with Parexel and ICON, and Takeda?s deals with Covance and Quintiles, which is driving mid-size CROs growth through major acquisitions.
Latest:
Microbiology & toxicology contract testing for the pharmaceutical and medical device industriesWickham Laboratories Ltd is a trusted name in the pharmaceutical and medical device industries with over 50 years of experience in contract testing, research and consultancy.
Latest:
Partnership Models Structure R&D ChangePharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.
Latest:
Cleaning Validation for Pharmaceutical ManufacturingThis paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.
Latest:
Excipient Science in Protecting Moisture Sensitive DrugsDon’t just rely on packaging to protect drug products from moisture. In this webcast, discover how to develop more stable formulations by selecting the right excipients for use with moisture-sensitive drugs, and in doing so, reduce the risk of degradants and impurities. Live: Asia Pacific: Wednesday, Jun. 3, 2020 at 12pm IST | 2:30pm CST | 3:30pm JST US and Europe: Wednesday, Jun. 3, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Jun. 3, 2021 Register free
Latest:
Advances in the Pharmaceutical Industry Have Shaped Particle Sizing TechnologyA diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.
Latest:
Centrifuges Used in Pharmaceutical Manufacturing: A PrimerFour types of centrifuges used in pharmaceutical manufacturing have different features.
Latest:
Emerging Opportunities with BiosimilarsTo realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.
Latest:
Making the Move to Electronic Batch RecordsImplementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
Latest:
Making the Move to Electronic Batch RecordsImplementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
Latest:
Pulling Together to Advance Patient-Focused Drug ProductsMore work needed to advance drug design and development effectively.
Latest:
Future Therapies Using Implanted Engineered Cells as Protein FactoriesResearchers at MIT have discovered a new set of compounds that do not elicit a foreign body response when implanted. These biomaterials permit the development of a new category of treatment with the ability to deliver therapeutics either at a constant rate or under programmable conditions by using implantable cells as protein factories.
