Fluorescence spectroscopy offers unique advantages for characterizing EVs.
***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT*** A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.
This SGS Health Science whitepaper uncovers the changing regulatory environment, and the challenges posed by the detection of nitrosamine impurities in drug products.
Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.
Continuous SEC was shown to increase productivity with the same product quality and yield.
Quality management is inherently complex. That’s why you need QMS software that’s suited to your company’s unique needs. This comprehensive resource shows you the key quality management software features to look for and ways modern tools can give you an edge today while paving the way for success tomorrow. Wherever you are on your buyer journey, the foundation provided in this guide will help you make the right choice.
Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.
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.
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Autologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
Science is propelling advances and operational shifts in the bio/pharmaceutical industry.
The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
Thu, Sep 8, 2022 11am EST | 8am PST | 4pm BST | 5pm CEST Digitalization & leveraging real-time data are key for biopharma process improvement. Insilico models and soft-sensors boost biopharma performance to unprecedented levels.
This application note explores the feasibility of utilizing the scale-X carbo bioreactor as a solution for seed train intensification.
This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.
This study evaluates the best-in-class elastomer compounds, formulations, and coatings, affixed with aluminum seals and press-on caps to Type I borosilicate tubular glass vials conforming to the International Organization for Standardization (ISO 8362) injection containers requirements.
Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
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.
In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.
Critical considerations for deploying smart, fast, and flexible Life Sciences facilities
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
The panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.