All articles about Manufacturing Processes

Manufacturing Processes

Cryogenic Freezing: All you need to know

Cryopreservation is an effective procedure for the quality-preserving storage of many biomaterials. Find out what cryopreservation actually is, what has to be considered along the process and where it is applied – all summed up in this article.

daniel-tischler

Daniel Tischler

August 1, 2022

Manufacturing Processes

Case Study: Reducing product loss | Hybrid for primary packaging

Harmonize the process for different types of single-use primary packaging. Protective shell solutions and hybrid systems optimize liquid transfer in Biopharma. 

Claus Exenberger - Single Use Support

Claus Exenberger

July 28, 2022

Manufacturing Processes

Pharmaceutical cold storage – overview of all freezing ranges

Temperature plays a significant role in the production and distribution of several revolutionary biologics. But how does the pharmaceutical cold chain work, and what temperature ranges are most frequently chosen? You will find out in this article!

Alexander Fuchs | Single Use Support

Alexander Fuchs

July 25, 2022

Manufacturing Processes

Ultra-cold freezing and storing – considerations & solutions

Implementing cold freezing and storing in supply chains is oftentimes inevitable when dealing with certain biopharmaceuticals. Learn what the main considerations are and find out how to face related challenges.

daniel-tischler

Daniel Tischler

July 19, 2022

Manufacturing Processes

Case Study: Reducing product loss | Bag-independence

Learn about the benefits of supplier-agnostic solutions around single-use bioprocess containers that help minimize product loss.

Claus Exenberger - Single Use Support

Claus Exenberger

June 20, 2022

Manufacturing Processes

Case Study: Reducing product loss | Cost-efficiency

It is the key issue in the management of bulk medicines: How can product loss be avoided or at least reduced? This article explains everything about this topic!

Claus Exenberger - Single Use Support

Claus Exenberger

June 8, 2022

Manufacturing Processes

Plate freezing: best approach for freezing biopharmaceuticals

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, with several advantages for biopharma.

Alexander Fuchs | Single Use Support

Alexander Fuchs

May 18, 2022

Manufacturing Processes

Industry 4.0 in Biomanufacturing: RoSS.KSET as an example

Industry 4.0 has long become reality in many branches. In Pharma 4.0 intelligent industrial applications and IoT enable players in the bioeconomy industry  to transition to operations that help them improve their productivity. Pharma 4.0 also has become a major part in single-use technologies, as it brings companies to the next level concerning the scalability, productivity and efficiency of their processes and products. 

michael-muehlegger

Michael Mühlegger

May 18, 2022

Manufacturing Processes

Extractables and leachables: definitions, differences & facts

Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. While extractables and leachables both describe foreign matter that can lead to contamination of highly valuable drug products, it is important to understand their characterization but also the difference between the two.

1640281789974

David Seifert

April 12, 2022

Manufacturing Processes

Storage Density in Biopharma Manufacturing Facilities

Single-use bags with its flat shape is predestined for stacking and offer great solutions to increase storage density on-site but also for shipment. The combination of both, single use bag and RoSS® shells (Robust Storage and Shipping) makes them a cost-effective solution, as they require little storage space. RoSS® shells are available for all sizes and suppliers of single-use bags.

micheal-eder

Michael Eder

March 24, 2022

Manufacturing Processes

How Pharma 4.0 eliminates human errors in pharmaceutical industry

Pharma 4.0 aims at improving risk management. It aims at updating the pharmaceutical industry and ensuring data integrity by incorporating advanced digital formats and enablers into the current Pharmaceutical Quality System (ICH Q10). The final goal is to minimize, if not eradicate, human error. 

michael-muehlegger

Michael Mühlegger

March 23, 2022

Manufacturing Processes

Scalability of single-use drug substance production

The aim was to achieve a freezing process where the last point of freeze always happens at the same time throughout all scales. If successful, the generated freezing curves will look very similar. Temperature ramps have been used to slow down or accelerate the freezing process.

micheal-eder

Michael Eder

March 21, 2022