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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Ensuring Cell Line Stability for Protein TherapeuticsStable cell line development can benefit from applying integrated analytical technologies.
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Evolving Complexities In BioAnalysis: Addressing Sensitivity, Selectivity and Sample ComplexityEvolving therapeutic modalities increase bioanalytical complexity, making ion mobility spectrometry–mass spectrometry (IMS-MS) crucial for enhanced sensitivity and selectivity.
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Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
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Executive Summary: Addressing Regulatory Requirements for CRISPR sgRNA Purity with Orthogonal ChromatographyThe increasing demand for high-purity, regulatory-compliant guide RNA (gRNA) manufacturing in the CRISPR gene editing market underscores the need for advanced production capabilities.
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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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The Evolution of Cellular Therapies in a New Clinical Research EnvironmentThe clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.
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Leveraging Blow-Fill-Seal Technology for Biologic DeliveryThe rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.
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Virus-like Particles as Therapeutic Moieties of the FutureAnalytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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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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Addressing manufacturing at scale for ATMP’sAddressing manufacturing at scale for ATMP’s. Reducing costs through reducing batch failures and shrinking footprints, and targeting more focused critical quality attributes for potency but also patient efficacy. Reducing regulatory uncertainty in an uncertain environment to increase patient access to life saving cures.
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Mastering Antibody-Drug ConjugatesIn this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
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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.
