Authors
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The Relevance of Industry Technical AssociationsIndustry associations play a strong role in helping the pharmaceutical industry meet challenges.
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Optimizing the Delivery of Cell-Culture AdditivesWhen using media supplements in biologics, it is important to have a key understanding of both the supplement and the base medium to ensure high titer and stability.
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Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Vector Manufacturing and Testing for Gene and Cell Therapy ApplicationsThe authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
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Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Bolstering Graduate Education and Research ProgramsAAPS supports graduate-level programs impacted by cutbacks in funding and resources.
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Standardizing Practices for Cellular Therapy ManufacturingCellular therapy developers learn process development strategies from pharma industry experiences.
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Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal AntibodyDespite different material, agitation, and aeration, the performance of the disposable bioreactor is similar to that of stainless steel bioreactors.
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Vector Manufacturing and Testing for Gene and Cell Therapy ApplicationsThe authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Setting Standards for Biotech Therapeutics in IndiaThe authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
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Stirred-Tank Bioreactors Sf9 Culture for BeginnersThis application note presents a protocol for Sf9 insect cell culture in stirred-tank bioreactors and recombinant protein production via a baculovirus vector system.
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Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Continued Process Verification for Biopharma ManufacturingThe authors discuss complications of implementing continued process verification and provide recommended approaches.
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Quality Agreements for Contract ManufacturersA well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.
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Quality Agreements for Contract ManufacturersA well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.
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Vector Manufacturing and Testing for Gene and Cell Therapy ApplicationsThe authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
Latest:
Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
Latest:
Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical BiopharmaceuticalsFed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
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Setting Standards for Biotech Therapeutics in IndiaThe authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
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Assessing a Risk Management ProgramProgram review can help quality risk management live up to the promise of ICH Q9.
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Continued Process Verification for Biopharma ManufacturingThe authors discuss complications of implementing continued process verification and provide recommended approaches.
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Bolstering Graduate Education and Research ProgramsAAPS supports graduate-level programs impacted by cutbacks in funding and resources.
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A Review of the Challenges of Delivering Macromolecule BiologicalsSelecting a delivery method early on may be beneficial.
