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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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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.
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Considering a Coating Technology as an Alternative to Silicone OilA coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
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Elements for a Sustainable Environmental Monitoring ProgramAsking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.
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Therapeutic Delivery for Brain-Related ConditionsAt BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.
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Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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Connected Software Solutions Streamline Biopharma MS WorkflowsThe integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.
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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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How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
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Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
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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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Using Modeling to Improve Data Analytics for Upstream Bioprocessing WorkflowsRecent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
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Bioreactor, PAT and Lucullus Control SynergiesThe Lucullus process information management system facilitates bioprocess development and optimization by centralizing data management and control of multiple BR1000 bioreactor systems that each employ dynamic PAT-driven glucose feeding
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Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product QualityIn part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.
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Challenges in Bulk Drug Substance ManagementHow can liquid drug substances be safety stored and transported between downstream and fill/finish processes?
