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Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility StudyContinuous SEC was shown to increase productivity with the same product quality and yield.
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Points to Consider for Continuous Downstream BioprocessingIt is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
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ML and AI Implementation Insights for Bio/Pharma ManufacturingA survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.
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Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process OptimizationIn this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
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Advancing Drug Supply Chain Management, Strategic Sourcing and Supplier CollaborationThe biopharmaceutical industry supply chain experiences many bottlenecks, some of which may impact the sourcing of biochemicals and raw materials necessary to fulfill manufacturing demands during late stages of drug development. Establishing a partnership with a raw materials supplier with expertise in sourcing can be beneficial in navigating any unexpected turbulence and mitigating more common issues.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange 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.
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Lifesaving Logistics: Today's Cold ChainThe entire clinical supply chain — from manufacturer to shipper to clinician to patient — is united in its reliance on cold chain solutions to consistently deliver quality of life and potentially lifesaving treatments. Learn more about how to navigate a vast array of temperature-controlled shipping options across five specific temperature ranges while ensuring product integrity and patient safety.
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Key Considerations in Aseptic Fill Finish CMO FacilitiesFill finish (sterile filtration) operations are critical and often the only means to produce sterile liquid biopharmaceuticals as other means of sterilization will degrade the product(s). This complex packaging process has become more regulated and controlled in an effort to reduce the risks of contamination (with the greatest risk potential coming from cleanroom operators). This episode reviews current market trends and provides some characteristics expected of a top notch Fill Finish CMO, like Samsung Biologics in Incheon, South Korea.
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Polysorbates: Part(icle) of the Problem?A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
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De-Risking Sterile Pharma Manufacture with SUTsSingle-use technologies provide a barrier between operators and drug products, allowing for sterility and personnel safety in manufacturing.
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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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Accelerating Time-to-Insight Across the BioPharma LifecycleA strong digital backbone is foundational in driving innovation.
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Formulating Autologous Therapies for CancerAutologous tumor cells engineered for immune system stimulation can target unique metabolic, genomic, and phenotypic characteristics of cancer cells.
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Reducing Risk: Establishing Consistency and Scalability of Cell Therapy Starting MaterialTaking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.
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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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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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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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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.
