Mergers and acquisitions have come to define both growth and consolidation in pharmaceutical manufacturing over the last decade. Often, a merger or acquisition is the quickest, most cost-effective way to realize advanced capability without building a facility from the ground up. Buying specific capacity that either is lacking or will bolster a company’s overall offering generally makes more sense for both budgets and bottom lines — especially when dealing with an undervalued company. However, even a successful merger or acquisition of manufacturing facilities creates a range of asset management issues, including determining the fate of redundant operations and equipment.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.
Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
A cornerstone of long-term maintenance is optimizing life cycle costs of investments during decision-making. This article discusses how predictability of costs and profitability can be enhanced.
Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. Here are tips to ensure a successful outcome.
This study presents how strategic enhancements to the sparge and agitation systems of Thermo Scientific HyPerforma S.U.B.s have revealed the potential for a three- to four-fold improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.
Pharmaceutics International, Inc. (Pii) is a premier Contract Development and Manufacturing Organization (CDMO). Download our brochure to see our complete list of parenteral manufacturing, liquid manufacturing, solid manufacturing, and analytical capabilities.
As the biopharma industry identifies faster and more efficient ways to deliver drugs to patients, such as break-through and fast track designations for accelerated approval, these progresses create pressure on both large and small drug manufacturers. As development timelines shorten, decisions related to drug commercialization need to be taken earlier, when key results are not yet available. And deciding on the scale and type of facility to build without complete data can create substantial risks with costly consequences.
There are a variety of business challenges from changing clinical trial plans to forecasting difficulties particularly for specialized medicines and orphan drug products and as such. Choose a partner that can provide tailored solutions to meet your unique development, manufacturing and packaging outsourcing needs.
Leverage our experience to give your product an inside edge. Our vast knowledge is based on commercial success that we then apply to find the right solution tailored to meet your product's needs.
The Quadro Comil / High Shear Diosna Milling and Granulation Enclosure designed to provide personnel protection down to a respiratory exposure concentration of 100 nanograms per cubic meter (ng/m3) during milling and granulation operations.