Drug Product Formulation Testing with Transport Simulation
Large-molecule drug products in solution may be susceptible to denaturing when exposed to shock, vibration, temperature and pressure, which occur …
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13 Keys to a Successful Monoclonal Antibody BLA Submission
When a monoclonal antibody therapy advances through its development lifecycle, planning ahead and optimising the biopharmaceutical cold chain is key …
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Support Your Regulatory Global Requirements: A Cold Chain Process Validation Guide
Competing priorities, changing expectations, cost pressures, sustainability initiatives and emerging markets ‒ these are some of the challenges facing cold …
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How to Navigate the FDA’s Guidance on Rare Diseases: A Guide for Biopharma Companies
The biopharmaceutical industry is at a pivotal moment, particularly those involved in developing drugs for rare diseases. The recent guidance from …
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Pfanstiehl Solutions for Complex Bispecific or Trispecific Antibody Formulations
Stabilising bispecific or trispecific monoclonal antibodies (mAbs) presents several challenges due to their complex structures and the increased likelihood of …
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Pfanstiehl Solutions for Inhalation-Grade Excipients in Enhancing Biologic Therapeutics
Inhalation-grade excipients are specialised substances used in the formulation of inhalable pharmaceutical products. These excipients must meet stringent quality and …
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Pfanstiehl Solutions to Reduce Surfactant Degradation in Biologic Formulations
Surfactants are critical components in pharmaceutical formulations, particularly in emulsions, suspensions and certain solid-dosage forms. They reduce surface tension between …
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Pfanstiehl Solutions for High-Concentration Antibody Formulations
The development of high-concentration antibody formulations (HCAFs) of greater than 100mg/ml is essential for the creation of monoclonal antibody (mAb) …
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Pfanstiehl Viscosity Reduction Solutions
High viscosity in protein therapeutics can have several harmful effects, both in terms of manufacturing and clinical administration. These include manufacturing …
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Pfanstiehl Protein Aggregation Reduction Solutions
Protein aggregation is the spontaneous clustering or clumping together of protein molecules, resulting in the formation of larger structures called …
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Pfanstiehl Vaccine and Biologic Stabilisation Solutions
Proteins in biologics and vaccine formulations are sensitive molecules that can undergo denaturation, aggregation or degradation under various conditions, such …
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Antipeptide Antibodies: Immunological Methods and Protocols
Antipeptide antibodies have a number of uses in biological research and bioassay; for example, they can be very useful for …
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Why Bioconjugation Is So Important to Peptides
The interface between chemistry and biology becomes well and truly blurred by the cutting-edge technology of bioconjugation. The ability to chemically …
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N-Acetylgalactosamine Clusters in Drug Delivery
The interactions of carbohydrates with their receptors is one of the core principles that has allowed for the great diversity …
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Enzyme Substrates Toolbox Part I: Chromogenic Substrates
Welcome to part one of the Biosynth handbook of enzyme substrates. These important products find applications in various sectors from …