The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
As a result of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a ‘new normal’.
Thursday, August 5, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST
Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.
The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
Developing bioassay methods requires a new approach for cell and gene therapy drug development.
Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
Find out how the NanoFlowSizer’s THALIA system is capable of measuring particle size in continuous liposome manufacturing with low lipid concentrations, below 3 mg/mL.
A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
Delivery of robust E&L programs by leveraging Agile software development methodologies in the laboratory.
The case for migrating from a paper-based quality management system to a digital platform is presented.
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
In order to combat the threat of counterfeits in Europe, the EU's current anti-counterfeiting directive is being amended.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
Webinar Date/Time: Fri, Dec 13, 2024 11:00 AM EST
Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.
A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.
Several steps need be taken to achieve lights-out, fully automated operations.
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
Wednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.
Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.
This article discusses the benefits and advantages of liquid-filled hard capsule manufacturing from formulation, development and full-scale production
The complexity of the RNA production process creates challenges.