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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Antibody Purification Process Development and ManufacturingDownstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.
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CMC Due Diligence for Accelerated Biologic Drug Development and ManufacturingThe growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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Plants As an Innovative and Accelerated Vaccine-Manufacturing SolutionA plant-based expression system could provide greater speed and capacity at a comparatively low cost.
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Bioengineered Protein A Polymer Beads for High-Affinity Antibody PurificationThe authors discuss an alternative to traditional Protein A resins.
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Outsourcing Lean Quality ManufacturingRapid microbial screening provided by contract laboratories can save companies time and money.
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New Strategies for Managing Single-Use ComponentsDual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
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New Strategies for Managing Single-Use ComponentsDual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.
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Automated Concentration and Diafiltration of Multiple siRNA SamplesProject: transfer a manual concentration/diafiltration process for siRNA production.
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Extractables and Leachables: Determining Risk in Single-Use SystemsAs SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
Latest:
Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto ReductaseIn this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.
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Plants As an Innovative and Accelerated Vaccine-Manufacturing SolutionA plant-based expression system could provide greater speed and capacity at a comparatively low cost.
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Offering a Biopharma View of Social MediaEver since Twitter launched in 2006 and Facebook became mainstream, most industries have sought ways to connect with their consumers through social media.
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Best Practices in the QC Micro LaboratoryStrong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
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De-risking Biologics Development Through Advanced Mass Spectrometry ApproachesUsing advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
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From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank BioreactorsJoin Ankita Desai from Eppendorf and Arie Reijerkerk from Ncardia in this webcast and Q&A session to learn about the benefits of stirred-tank bioreactors for the drug discovery and development process. Get insights about how the advent of human-induced pluripotent stem cell (hiPSC) technology has substantially expanded the availability of human cells. Live: Monday, Sept. 16, 2019 at 9am EDT | 2pm BST | 3pm CEST On demand available after airing until Sept. 16, 2020 Register free
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Considerations in Demonstrating Interchangeability with a Reference Biologic ProductSponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
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Considerations in Demonstrating Interchangeability with a Reference Biologic ProductSponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
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Considerations in Demonstrating Interchangeability with a Reference Biologic ProductSponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
