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Strategy for Derivation and Optimization of a Clonal HEK293 Suspension Cell Line for High Yield AAV ProductionThis commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.
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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
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The Pros and Cons of Adherent Versus Suspension Cell CultureBoth adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.
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The Next Generation of Software Validation: Self-Validating SoftwareThursday September 9, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST Is computer software validation (CSV) holding you back from adopting the latest technology. Join this webinar for a look at the future of software validation and how it will remove the documentation burdens.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating 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.
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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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Scientific Due Diligence: The Key to Successful PartnershipsMergers, acquisitions, or partnership agreements in the biopharma sector often flounder due to poor preparation and missteps during scientific due diligence.
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Improving IR Spectroscopy as a Tool for Biopharmaceutical AnalysisMicrofluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.
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Addressing the Key Pitfalls Hindering Technology Transfer SuccessIn this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.
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Predicting Extractables and Leachables from Container StoppersData from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
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Improved Formulations to Enable Stable Delivery of BiologicsHow dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.
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iMRI-Guided Gene Therapy and Drug Delivery for CNS DisordersLeveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.
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Gibcoᵀᴹ CHO Cell Culture Solutions for BiomanufacturingGain access to essential strategies and solutions for optimizing your CHO cell culture workflow. This exclusive resource offers valuable insights and practical guidance tailored to the challenges of scaling up monoclonal antibody manufacturing with CHO cells.
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Addressing the Training Gap for Single-Use TechnologiesWorkforce training is crucial for biopharmaceutical manufacturing.
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Shining a Light on Lipid Nanoparticle CharacterizationUsing an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
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The Marriage of RNA and Mass SpectrometryConsiderable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***
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Designing a Control Strategy for Facilities with Single-Use SystemsEarly control architecture decisions can impact a facility’s long-term growth, flexibility, and efficiency.
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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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Overcoming oncolytic virus therapy production challenges through collaborationDiscover how ReciBioPharm’s strategic approach helped to support the rapid delivery of an innovative oncolytic adenovirus therapy for advanced cancer to clinic.
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Biopharmaceutical Excipients: Everything You Need to KnowThis article represents a comprehensive exploration about biopharmaceutical excipients, exploring their multifaceted classification, active role in drug formulation processes, inherent challenges, and upcoming advancements poised to revolutionize the drug formulation and its efficacy for patient welfare.
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EASY: a Disruptive mAb Purification Process to Reduce Cost of GoodsThe development of an innovative purification process simplifies downstream processing for biologics.
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Designing Flexible Fill/Finish FacilitiesScenario modeling informs planning for current and future manufacturing needs.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Digitalization: The Route to Biopharma 4.0The implementation of Industry 4.0 is projected to save time and cost for designing an optimal manufacturing process.
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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.
