RoSS® Shell | Protecting Single-Use Bags
Precision Fluid Management for ADCs
The hidden gaps in the fill-to-freeze workflows
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Most bulk drug substances are filled into 2D single-use bags for one reason: they are about to be frozen. Yet filling and freezing are often treated as separate unit operations. Filling systems are selected for accuracy and throughput. Freeze-thaw...
Despite the popularity of single-use bags for primary packaging, single-use bottles remain critical for storing, transferring, and sampling media, buffers, and drug substances throughout the biomanufacturing workflow. These sterile, reliable, and ...
The hidden risk in biomanufacturing Manual bottle filling in biopharmaceutical production is more than a routine task - it’s a high-stakes responsibility. From upstream cell culture to downstream purification, every step is tightly controlled - un...
Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation in flat primary packaging, such as single-use bags. [[ToC]] ...
In the dynamic landscape of pharmaceutical manufacturing, the journey from laminar flow to automated fluid management has been nothing short of transformative. This evolution, marked by innovation and adaptability, has reshaped the way smaller vol...
Fluid management in biopharma has changed considerably in recent years. With the advances in life science and the related healthcare adaptations, the manufacturing and supply chain divisions of biopharmaceutical companies are going through a major...
With the rising need for novel therapies - and, based on the changes in the disease landscape as most currently highlighted by COVID - the global biopharmaceutical industry is evolving, and market needs are shifting. We are seeing an increasing...
[[ToC]] Single Sourcing vs. Dual Sourcing Do you remember when lead times were months instead of weeks? During the COVID-19 pandemic, biomanufacturers faced several significant supply chain challenges: Lockdowns and restrictions led to disrupt...
The choice of single-use bioprocess containers in biopharmaceutical handling has had consequences for the performance and requirements in biomanufacturing until now. Lack of compatibility and inflexibility of platform systems have determined futur...
Single-use components might not be considered as the most essential parts in biopharmaceutical manufacturing. However, they are quite capable of temporarily paralyzing the entire production of biopharmaceuticals on-site. Procurement bottlenecks of...
In order to comply with the versatile requirements of today’s market, flexibility and the option to customize are key whilst maintaining availability and short lead times. This is true for many areas, not least when it comes to the ever-growing nu...
Twenty years ago there was only steel. Biopharmaceutical manufacturing has been conducted by fixed stainless-steel installations for a long time. Pharmaceutical products were produced in rigid, inflexible vessels and pipings by cell culturing a...
[[ToC]] Manufacturers of aseptic single-use connectors: Their advantages in an overview Aseptic connectors link important medical applications with one another. Preferrably easy and quick to use and it must grant sterility, even if the environment...