Related Experiment Video
Updated: Jul 16, 2026
08:06
Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
Published on: November 10, 2016
7.6K
Investigation of the Impact of Manufacturing Methods on Protein-Based Long-Acting Injectable Formulations: A
Nihan Yonet-Tanyeri1, Robert S Parker1,2,3, Louis D Falo2,4,5,6
1Department of Chemical Engineering, University of Pittsburgh, 940 Benedum Hall, 3700 O'Hara Street, Pittsburgh, PA 15213, USA.
Pharmaceutics
|October 26, 2024
Summary
Microfluidics manufacturing offers superior control over protein-loaded microparticle quality attributes and batch consistency compared to conventional methods, crucial for effective drug delivery.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Microparticle drug delivery systems enhance protein-based formulations for improved patient compliance and therapeutic outcomes.
- Continuous manufacturing via microfluidics is increasingly used for drug-encapsulating microparticles, but comparative data for protein drugs is limited.
- This study addresses the need for comparative assessments of batch versus microfluidics methods for protein-loaded microparticles.
Purpose of the Study:
- To generate immunomodulatory protein drug-loaded injectable formulations using both conventional batch and microfluidics methods.
- To comparatively assess critical quality attributes of microparticles produced by each method.
- To evaluate batch-to-batch variations in protein-loaded microparticle manufacturing.
Main Methods:
- Preparation of recombinant human C-C motif chemokine ligand 22 (rhCCL22)-loaded poly(lactic-co-glycolic) acid (PLGA) microparticles.
- Utilized conventional homogenization and microfluidics manufacturing techniques.
- Comparative analysis of microparticle size, size distribution, morphology, encapsulation efficiency, and release kinetics.
Main Results:
- Microfluidics method yielded microparticles with narrower size distribution and less surface porosity compared to the conventional method.
- Significant differences in drug release kinetics were observed between the two manufacturing methods.
- Microfluidics method demonstrated minimal batch-to-batch variation for protein-loaded microparticles.
Conclusions:
- Manufacturing method significantly impacts critical quality attributes of protein-loaded microparticles.
- Microfluidics offers enhanced control and consistency for producing high-quality protein-loaded microparticles.
- Comparative assessment is vital for ensuring efficacy, regulatory compliance, and quality control in drug formulation manufacturing.
Related Concept Videos
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
01:17In Vitro Drug Dissolution: Alternative Methods
Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
01:30Modified-Release Drug Delivery Systems: Bioavailability
Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
01:30Production of Pharmaceuticals
Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...