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Related Concept Videos

Single-pass Transmembrane Proteins01:25

Single-pass Transmembrane Proteins

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Integral membrane proteins are tightly associated with the cell membrane and play a crucial role in cell communication, signaling, adhesion, and transport of the molecules. Some integral membrane proteins are present only in the membrane monolayer. For example, the enzyme fatty acid amide hydrolase is present in the cytoplasmic side of the membrane monolayer. In contrast, another type of integral membrane protein, also known as a transmembrane protein, spans across the membrane. Transmembrane...
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Insertion of Single-pass Transmembrane Proteins in the RER01:26

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Integral membrane proteins are proteins adhered to the lipid bilayer of a cell organelle or membrane. They can be of two types: transmembrane integral proteins that span the lipid bilayer and monotopic proteins that are attached to either side of the membrane but do not pass through it.
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First Pass Effect01:12

First Pass Effect

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Presystemic elimination, or the first-pass effect, is the metabolism of drugs that reduces their effective concentration at the site of action. Apart from the first-pass effect, the systemic bioavailability of the drug is also reduced by other factors, including incomplete absorption or chemical degradation of drugs.
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Factors Influencing Bioavailability: First-Pass Elimination01:23

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When a drug is taken orally, it undergoes a journey starting from the gastrointestinal (GI) tract, passing through the portal vein, reaching the liver, and finally entering the systemic circulation. This process involves the absorption of the drug across the GI tract. The liver is the primary site for metabolizing the drug, with some metabolism also occurring in the gut wall. This journey significantly reduces the quantity of the drug that reaches the systemic circulation, a phenomenon known as...
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Insertion of Multi-pass Transmembrane Proteins in the RER01:29

Insertion of Multi-pass Transmembrane Proteins in the RER

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The rough ER membrane synthesizes, assembles, and embeds transmembrane proteins in diverse topologies. These proteins function as transporters or channels and can remain in the ER membrane or are sent to the Golgi complex, lysosome, and cell membrane.
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Integration by Parts: Indefinite Integrals01:26

Integration by Parts: Indefinite Integrals

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Integration by parts is a fundamental technique in calculus for evaluating integrals involving the product of two functions. It is particularly useful when direct integration is not feasible. The method is based on the product rule for differentiation, which states that the derivative of a product equals the derivative of the first function times the second, plus the first function times the derivative of the second. By integrating this identity and rearranging terms, the integration by parts...
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Multi-analyte Biochip MAB Based on All-solid-state Ion-selective Electrodes ASSISE for Physiological Research
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Single Pass Diafiltration Integrated into a Fully Continuous mAb Purification Process.

Joanna Rucker-Pezzini1, Lindsay Arnold1, Kevin Hill-Byrne1

  • 1MedImmune, Gaithersburg, MD 20878.

Biotechnology and Bioengineering
|April 13, 2018
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Summary

Continuous manufacturing in biopharma is advancing with a novel single pass diafiltration. This method achieves over 99.75% buffer exchange, enabling fully continuous monoclonal antibody purification.

Keywords:
ContinuousDiafiltrationSPDFSPTFFUFDFmonoclonal antibody

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Chemical Engineering
  • Process Chemistry

Background:

  • Continuous manufacturing offers significant advantages for the biopharmaceutical industry, including enhanced productivity and reduced facility footprint.
  • Existing technologies support continuous chromatography and ultrafiltration, but a fully integrated continuous diafiltration step is lacking.
  • Small molecule clearance and integration into a complete monoclonal antibody (mAb) purification process remain key challenges.

Purpose of the Study:

  • To present the theory and design of a novel 3-stage single pass diafiltration (SPD) system.
  • To demonstrate the feasibility of SPD for achieving high buffer exchange efficiency in continuous mAb purification.
  • To integrate SPD into an end-to-end continuous bioprocessing workflow.

Main Methods:

  • Development and theoretical analysis of a 3-stage single pass diafiltration system.
  • Experimental validation of buffer exchange efficiency and small molecule clearance.
  • Integration and demonstration of the SPD step within a pilot-scale, end-to-end continuous mAb purification process.

Main Results:

  • Experimental demonstration of over 99.75% buffer exchange efficiency.
  • Successful integration of the SPD step into a continuous process, maintaining uninterrupted flow from bioreactor to formulation.
  • Minimized system complexity and reduced buffer volume requirements through critical design aspects.

Conclusions:

  • The presented 3-stage single pass diafiltration design is effective for high-efficiency buffer exchange.
  • Single pass diafiltration is a feasible and valuable unit operation for end-to-end continuous biopharmaceutical manufacturing.
  • This advancement supports the broader adoption of continuous processing in monoclonal antibody production.