Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.
Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.
Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.
The 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.
Tableting 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.
Advanced 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.
Advanced 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.
Machine vision and optical character recognition technologies enhance inspection of packages and labels.
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.
Integration 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.
The 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.
The 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.
The 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.