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...
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...
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 disruptions in ...
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...
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 around ...
Ensuring the integrity of filtration processes is fundamental for the safety of bioprocessing. Among the array of methods available for assessing filter integrity, the bubble point test emerges as one of the most frequently used techniques. By scr...
Filter integrity tests are essential in ensuring the reliability of biopharmaceutical processes – a stringent field governed by regulatory requirements such as those set forth by the FDA and GMP standards. These tests are critical components in up...
Annex 1 of GMP is a set of regulations guiding the manufacturing of sterile medicinal products, setting stringent regulations for biopharmaceutical processes. Within this set of regulations, PUPSIT stands out as a fundamental procedure to ensure t...
Addressing Challenges in Aseptic Filling Accurate and efficient filling of biopharmaceuticals in primary packagings, such as single-use bags and bottles, is crucial. Even the smallest deviations in the filling volume can have a huge impact on ...
Aseptic filling represents a fundamental process within pharmaceutical manufacturing, serving to preserve the potency and safety of biologics throughout the production process. With stringent standards issued by regulatory authorities like the FDA...
