Biopharmaceutical Products
Scale-up and industrial production of ADCs face complications due to the high safety measures which need to be taken to guarantee product efficacy and a protected working environment for staff and manufacturers. In this article we seek out to give you an overview of the different challenges during ADC manufacturing while also introducing solutions which help to ensure aseptic production methods through single-use-technologies and end-to-end systems.
Brian Moloney
May 5, 2024
Biopharmaceutical Products
Therapeutic proteins hold promise in the treatment of numerous medical conditions, and progress in this field is far from being over. This is reason enough to take a general look at this class of therapeutics.
Alexander Fuchs
April 10, 2024
Biopharmaceutical Products
Prior to be used in diagnostics or therapeutics, proteins have to be safely stored. In this article, we will assess methods to preserve their stability upon storage.
Alexander Fuchs
April 10, 2024
Biopharmaceutical Products
Protein production is a crucial process that which a large variety of pharmaceutical products rely on. Therefore, we will discuss this procedure in this article, along with possibilities to improve it.
Khalil Essani
April 9, 2024
Biopharmaceutical Products
Protein stability is crucial to be maintained along the manufacturing process of protein-based products. In this article, we will discover what influences protein stability, along with methods to assess and increase it.
Khalil Essani
April 9, 2024
Biopharmaceutical Products
Active Pharmaceutical Ingredients (APIs) are the cornerstone of pharmaceutical drugs, serving as the primary agents responsible for delivering therapeutic effects to patients.
Michael Eder
March 21, 2024
Biopharmaceutical Products
Active pharmaceutical ingredients (APIs) are fundamental for drug products to be effective, but require special treatment – e.g. considering humidity, light, or temperature. In this article, we will highlight the different cold storage requirements of APIs, including examples and an overview of different practical approaches.
Alexander Fuchs
March 21, 2024
Biopharmaceutical Products
In a recent study, freezing protocols were tested with the RoSS.LN2F controlled liquid nitrogen freezer to find the optimal freezing rate for CHO-K1 cells in order to achieve maximum cell viability.
Alexander Fuchs
February 16, 2024
Biopharmaceutical Products
In this article we take a closer look at the top five companies in terms of annual revenue in the U.S., that dominate the field of antibody research, development and production. Further, we dive in the field of promising pioneers with a focus on mAb production for the use of cancer treatments.
Michael Eder
February 12, 2024
Biopharmaceutical Products
The objective of an optimal cryopreservation strategy is to deactivate (put on hold) degenerative cellular pathways and preserve proliferative potential by reducing the temperature below –130°C. To reduce the effects of ice crystal and osmotic injuries, cryopreservation protocols usually incorporate cryoprotective agents (CPAs).
Khalil Essani
February 8, 2024
Biopharmaceutical Products
Adequate quality control samples retained before cell therapy treatment are a crucial component of effective regulation and need to represent the conditions and history in the cryobag. A deep dive into GMP Annex 1 on ATMP Cryopreservation.
Khalil Essani
February 7, 2024
Biopharmaceutical Products
Monoclonal antibody development and manufacturing are highly specialized processes, demanding equally specialized equipment. We will discuss some essential tools and systems in this article.
Brian Moloney
February 7, 2024
Articles by Biopharmaceutical Products:
Articles by Manufacturing Processes:
E-Book
In this publication we show that the initial price can be deceiving and there are significant additional costs during ongoing usage in the long term. Plate freezers ensure a complete, consistent, and fast freezing (and thawing) to ensure the quality of your high-valued drug substance is maintained, and through simple lifecycle analysis they outpace conventional options regarding total costs.
E-Book
Homogeneity of pharmaceuticals plays a major role in fluid management. Liquid drugs have different viscosities, degrees of sedimentation, and other varying properties, making it difficult to standardize the aliquotation of liquids. RoSS.PADL is a homogenizing solution with kneading and cooling functions for standardizing the mixing of biopharmaceuticals precedenting the dispensation into single-use bioprocess containers. This fully automated and hence standardized process ensures homogeneous distribution of the liquids in single-use bio process containers.
E-Book
This guide for bioconjugate manufacturing with regards to fluid and cold chain management addresses challenges such as: protection against ADC toxicity, accuracy in fluid management, maintaining ADC stability after freeze-thaw cycles, transition from lab to commercialization, and cost considerations of equipment.
