Defense-in-Depth: Advances in Aseptic Manufacturing
Pharmaceutical manufacturers, especially those who produce sterile injectables, are in a fight for their lives battling contamination and the potential for contamination in their processes. This imperative is more than mandatory because aseptic process is at the heart of drug safety and quality. Creating sterile production environments require sophisticated mitigation strategies not only for "shop floor" but for the systems that process and handle the products from formulation to fill-and-finish routines. What's effectively creating the defense-in-depth tactics required to fend off contamination? Pharmaceutical Manufacturing talks to leading aseptic system integrators and plant designers to get their perspective on the technologies that support advanced aseptic manufacturing.
Advanced Filtration Technology for Viscous Fluids in Blow-Fill-Seal Operations
Unolab Manufacturing in Spain is dedicated to the manufacture of sterile products for third parties, using advanced Blow-Fill-Seal (BFS) technology. Unolab and other manufacturers of liquid drug formulations with highly viscous properties can find that fluid sterilization by filtration may result in filter throughput and flow-rate challenges. Here, Pall's Tom Watson discusses how Unolab significantly optimized their process by implementing polyethersulphone (PES) membrane filters to resolve recurring bottlenecks during the filling of its viscous products.
Prolong Expands its Operations and its Potential Success
Prolong Pharmaceuticals LLC recently announced the expansion of its South Plainfield, New Jersey biologics processing facility, adding 24,000 square feet and essentially doubling its capacity. The South Plainfield manufacturing facility has been used since early 2010 producing (at clinical scale) the company's large-scale biological oxygen transfer agent, SANGUINATE, in an effort to meet the likely commercial success and potential demand for its highly promising sickle-cell anemia therapy. Prolong's head of manufacturing and facilities, industry veteran Tom Flachmeyer, provides insight into the plant's innovative, ground-breaking processes and how it's being scaled to commercially deliver Prolong's equally ground-breaking biologic.
The Optimization and Scale Up of High Shear Granulation: Exploring The Benefits Of Real-Time Particle Sizing
There's mounting evidence that the information gleaned from the application of PAT to monitor and control oral solid dose (OSD) products in process in real time can yield significant quality and other benefits. Malvern Instruments takes a deep-dive into how laser diffraction-based PAT can inject an extra measure of excellence into granulation and other OSD operations.
Technology at Work
Kythera Manages Regulated Content Enterprise-Wide and Shaves TMF Reconciliation Time by 40 Percent
Kythera is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel prescription products for the aesthetic medicine market. Kythera needed a system to improve clinical document management and facilitate business processes for the development of its newest product candidate and turned to Veeva for a document solution that ultimately trimmed TMF reconciliation time by 40 percent.
Mixing and Blending
Product round-up from prominent equipment & technology suppliers.
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