Latest Articles
Upstream Intensification: Perfusion Bioreactors for Monoclonal Antibody Production
Perfusion cell culture systems are achieving cell densities over 100 million cells/mL, dramatically increasing volumetric productivity. We explore the engineering principles behind alternating tangential flow (ATF) filtration, single-use bioreactor design, and the economic trade-offs between perfusion and fed-batch strategies for mAb manufacturing.
Quality by Design (QbD) in Tablet Compression: Design Space Development for High-Speed Presses
Implementing QbD principles in solid dosage form manufacturing requires systematic understanding of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs). This deep-dive covers Design of Experiments (DoE) approaches for establishing a robust design space on rotary tablet presses operating at 400,000+ tablets per hour.
Lipid Nanoparticle (LNP) Engineering for mRNA Delivery: Lessons from COVID-19 Vaccines
The success of mRNA COVID-19 vaccines thrust lipid nanoparticle technology into the spotlight. This article examines the pharmaceutical engineering challenges of LNP formulation at scale — from microfluidic mixing parameters and ionizable lipid selection to lyophilization strategies for cold-chain-independent distribution.
FDA's Emerging Technology Program: Navigating Regulatory Pathways for Advanced Manufacturing
The FDA's Emerging Technology Team (ETT) provides a framework for pharmaceutical companies to engage early on novel manufacturing technologies. From 3D-printed dosage forms to continuous direct compression, we review recent case studies and outline strategies for successful regulatory submissions involving emerging tech platforms.
Gene Therapy Manufacturing: Scaling AAV Vector Production from Lab to GMP Facility
Adeno-associated virus (AAV) manufacturing remains one of the greatest bottlenecks in gene therapy. We examine upstream challenges including transient transfection vs. stable producer cell lines, suspension vs. adherent culture, and the downstream purification landscape encompassing affinity chromatography, ultracentrifugation, and TFF-based approaches.
Sustainable Pharmaceutical Manufacturing: Solvent Recovery, Waste Minimization, and Green Chemistry Metrics
The pharmaceutical industry generates 25-100 kg of waste per kg of active ingredient. This article reviews practical strategies for Process Mass Intensity (PMI) reduction, catalytic vs. stoichiometric reagents, bio-based solvent alternatives, and closed-loop solvent recovery systems that leading CDMOs are implementing to meet 2030 sustainability targets.