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Loss of drug substance - the challenges and chances

Vaccines

What are Active Pharmaceutical Ingredients (APIs)?

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

Freeze-thaw study protocols - Single Use Support

Vaccines

Cold Storage Requirements for Active Pharmaceutical Ingredients

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

RoSS.FILL Bag_Product Photo_Single Use Support-16

Fill & Filtration

Bubble point test: Purpose & Procedure

Among the possible filter integrity testing methods, the bubble point test belongs to the most frequent ones. Therefore, this article will describe the process along with its applications, benefits and limitations, and its automation.

David Seifert

March 20, 2024

Biopharma

Annex 1: All you need to know

Annex 1 is a fundamental framework for the production of sterile medicinal goods. This article will provide an overview of the concept, its history, contents, challenges, and perspectives.

Michael Mühlegger

March 20, 2024

Fill & Filtration

Annex 1 and the PUPSIT requirement

Annex 1 and PUPSIT meant significant changes in the pharmaceutical sector. In this article, we will illustrate the focus areas of Annex 1 and will discuss main aspects of PUPSIT.

Khalil Essani

March 13, 2024

Fill & Filtration

Overview of filter integrity testing methods

There are various approaches to validate the integrity of sterile filters, as is required by several regulatory frameworks. We will cover some of the most common methods in this article.

Khalil Essani

March 13, 2024

Biopharma

Top 7 pharmaceutical CDMOs in 2024

Progress in the pharmaceutical industry is significantly driven by CDMOs, collaborating with pharma companies. In this article, we will put 7 outstanding CDMOs in the spotlight.

Michael Mühlegger

March 12, 2024

Biopharma

CMO vs. CDMO: What are the differences?

Both CMOs and CDMOs are frequently relied on partners in the pharmaceutical industry. But what sets them apart, where are their strengths, and what do they offer?

Michael Mühlegger

March 12, 2024

Fill & Filtration

Evolving Aseptic Filling in Biomanufacturing

Laminar flow hoods and biosafety cabinets were the stalwarts of aseptic processing, providing controlled environments for fluid transfer tasks. However, as the demand for sterile drug products escalated and regulatory standards tightened, the industry embarked on a quest for more robust and efficient methods. Automated filling platforms now reduce the risk of contamination and guide the way to reproducible aliquot consistency, filling accuracy and speed.

Michael Eder

March 7, 2024

Single-use bag manufacturers biopharmaceutical market Single Use Support

Single-use Technology

Single-use bag manufacturers: the major players

The advanced platforms of the newest generation of single use bags are generally compatible with a variety of bag brands and volumes. One of these platforms is Single Use Support’s RoSS®, which offers the benefit of not only being bag agnostic but also highly flexible thanks to its modular design. Learn more about the biggest player in the industry!

Michael Eder

March 5, 2024

RoSS.FILL CGT Small Volumne_Product Photo-3-min

Fill & Filtration

Enhancing Process Flexibility With Automated Filling

In order to implement flow sensors with the highest precision, Single Use Support decided to implement SONOTEC's SONOFLOW CO.55 V3.0 ultrasonic flowmeters on its RoSS.FILL platforms for dispensing small volumes.
Discover the full benefits of SONOTEC's collaboration with Single Use Support for biopharmaceutical fluid management.

Michael Eder

March 5, 2024

Freezing Mammalian Cell Line for increased CHO cell viability

Cell & Gene Therapy

Study: Optimizing Cell Viability During CHO Cell Freezing

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

Recommended Downloads

E-Book

eBook: Filling Gaps in Managing Large Volumes of Biologics

Aseptic aliquotation and cryopreservation of drug substances are crucial process steps in bioprocessing. Even though they’re not in the spotlight of biomanufacturing. In drug development and drug delivery, biologics must be transferred at numerous occasions. Along the journey of monoclonal antibodies, vaccines and more, the drug substance passes lots of process steps where liquid transfer is required. This is relevant for the transitions between upstream processing, downstream processing and fill & finish, but also within these manufacturing milestones. The market of fluid & cold chain management has great growth potential and is on its way to professionalization and industrialization. To meet the challenges of manufacturing drug substances, Single Use Support helps manufacturers and CDMOs to advance their fluid & cold chain management process to achieve a secure and efficient process for liquids on the basis of single-use bags.

Single-Use-Support-Controlled-Freezing-Biopharmaceuticals

E-Book

Whitepaper: How Controlled & Scalable Freezing Becomes Reality

Scalability around freezing means the ability to guarantee constant freezing kinetics on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. This guide covers how to achieve scalable freezing & thawing of biopharmaceuticals by showing What is scalability? Setup for controlled icefront growth speed Scalability results Outcomes

aav-production-efficiency-improvements-single-use-technology

E-Book

Whitepaper: Automated Aseptic Filling

Read our Whitepaper about Automated Aseptic Filling in Pharmaceutical Manufacturing | Discover why automatic filling solutions are preferable to manual filling.