Authors
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Drug Product SecurityHigh-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.
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Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried FormsAFI 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.
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Get your time back. Quantitative Remote Monitoring for Cell Culture.Cell culture quality is critical to experimental success, but it can be time consuming and challenging to routinely record passages and confluency which effect cell physiology and phenotype. In this podcast we’ll discuss the importance of cell culture quality control for cell based assays and ways to reduce the time required with new automated remote monitoring and quantification tools.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without DisinfectantsControlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
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Oligonucleotide Production FacilitiesAs oligo manufacturers scale up production from lab-scale to clinical and commercial scales, they may require volumes of hazardous materials that drive additional facility design considerations.
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Meeting Secondary Packaging Challenges of Innovative Delivery Systems for BiologicsRapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.
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1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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Comparative Deterministic Cold Storage Headspace Analysis–Multi-sourced Injectable Container Closure SystemsThis 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.
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Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical ProcessingSpecialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.
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Trends Affecting Biopharmaceutical ManufacturingAlmost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
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Predicting Viral Clearance at Your BenchtopViral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, viral vectors, and plasma derivates.
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Advancing Cell & Gene Therapy Expansion processes with the Appliflex ST Single-use BioreactorIn this podcast, we will talk about advancing Cell & Gene Therapy expansion processes. A shift from traditional static and shaken cultivation conditions to a stirred controlled environment is taking place within this industry. Various applications will be discussed where the AppliFlex ST single-use bioreactor have enabled advances in process development.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Impact of Scalable Freeze/Thaw Cycling on Protein Stability & Structure**Wednesday, October 27, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST** Freezing and thawing at scale of API and BDS biologics is not routine and should be handled with the consideration given to any critical unit operation. This webinar highlights key protein related quality challenges associated with freeze methods. Optimization thorough model freeze/thaw studies are presented.
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Pharma Services Sector Poised for Continued Growth and ConsolidationThe 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.
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The Essential Ingredient in any Sponsor-CRO Partnership: TrustTo build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Streamlining Method Transfer Across Global SitesThis article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
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On the Brink of Commercialization: How do we bring ground-breaking cell and gene therapies to market faster?Tue, Sep 27, 2022 2:00 PM EDT | 11am PT | 2pm ET | 7pm BST Many novel cell and gene therapies (CGTs) are now entering the commercialization stage but, as developers look to recoup investment and quickly deliver life-saving therapies to the patients that need them, they face a myriad of challenges. In this webinar, learn how advanced therapy medicinal product (ATMP) platforms, using single-use systems, are delivering streamlined, efficient and cost-effective manufacturing solutions in this dynamic sector.
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Rapid Monitoring of Critical Quality Attributes Using Octet® BLIOctet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.
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Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
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Enzene Expands Into the US and Will Provide State-of-the-Art Fully Connected Continuous Manufacturing Services to Pharma and Biotech CompaniesDr Himanshu Gadgil, CEO, Enzene Biosciences Ltd., describes the rationale for expanding its services, including its patented EnzeneX™ continuous manufacturing technology platform, to emerging innovative, US-based biotech firms looking to benefit from the in-depth expertise in continuous manufacturing.
