Welcome to our Knowledge Hub

Good Manufacturing Practice (GMP) is the foundation of quality assurance in biopharmaceutical manufacturing. It ensures that therapeutic products, including cell therapies and viral vectors like Adeno-Associated Virus (AAV), are produced under strict quality control to meet safety, purity, and efficacy standards.

In cell culture, two primary growth methods exist: adherent culture and suspension culture. The choice between these methods depends on cell type, application, and scalability needs. While adherent cells require attachment to a surface for growth, suspension cells freely float in liquid media. Each approach has its unique advantages, limitations, and specific cultivation requirements.

The successful commercialization of cell and gene therapies (CGTs) depends on the ability to scale production efficiently while maintaining product consistency, safety, and regulatory compliance. A well-designed bioreactor scale-up strategy is critical in ensuring that processes developed in early-stage research can transition seamlessly into commercial-scale biomanufacturing.

The life science tools sector, particularly bioreactor technologies, is emerging as a high-growth investment frontier in Europe, combining scientific innovation with robust market dynamics. Driven by pandemic-era acceleration and sustained demand for biopharmaceuticals, this sector offers compelling opportunities for venture capital (VC) and institutional investors. Here's why bioreactors and related technologies are poised to deliver strong returns while advancing global hea

In the development and manufacture of advanced biopharmaceuticals—including cell and gene therapies—cell expansion is a critical step that directly influences yield, quality, and consistency of the final product. Maintaining a viable and productive cell population requires precise control over multiple parameters within the bioreactor environment. Among these, dissolved oxygen (DO) concentration in the liquid phase stands out as a critical process parameter (CPP).

Bioreactors are essential tools in biotechnology, enabling controlled environments for cell culture, fermentation, and metabolite production. Their role is crucial in biopharmaceutical manufacturing, regenerative medicine, and large-scale cell expansion. As bioprocessing demands grow, bioreactor scale-up becomes a key challenge, ensuring that laboratory-developed processes translate effectively into industrial-scale production.

Scalability is a fundamental challenge in bioprocessing, particularly in cell culture-based manufacturing. As the demand for advanced therapeutics, including cell and gene therapies, continues to grow, manufacturers must choose between two primary strategies for increasing production capacity: scale-up and scale-out.

Cell culture systems are the foundation of modern biopharmaceutical production, playing a crucial role in advanced therapy medicinal products (ATMPs), viral vector manufacturing, and cell-based therapies. The decision between 2D and 3D cell culture impacts scalability, process robustness, and final product quality, making it essential for manufacturers to select the right approach.

In recent years, Germany’s role in biotech has evolved, particularly in cell and gene therapy manufacturing, where its strong GMP expertise is both an asset and a challenge. While Germany remains a key hub for innovation, complex bureaucracy, extensive documentation requirements, and rigid GMP standards have made scaling advanced therapies slow and costly.

Cell and Gene Therapies (CGT) represent a groundbreaking advancement in modern medicine, offering curative potential for genetic disorders, cancer, and degenerative diseases. These therapies utilize engineered cells or genetic modifications to treat or replace damaged tissues and defective genes. All approaches demand highly controlled manufacturing processes to ensure safety, efficacy, and scalability.

Advanced therapies like cell-based therapies have emerged as a promising field in regenerative medicine, offering novel treatment approaches for conditions such as cancer, autoimmune diseases, and degenerative disorders. One critical distinction in these therapies is whether the cells come from the patient themselves (autologous) or from a donor (allogeneic). Both approaches have unique benefits and limitations, impacting their clinical application and scalability.

iPSCs and MSCs are transforming regenerative medicine by curing diseases once considered untreatable.

Stem cell cultivation of iPSCs and MSCs is essential to ensure scalability for regenerative medicine and advanced therapies.

Green Elephant adds a new member to CellScrew® series: CellScrew® mini as an entry-level solution for efficient, scalable cell culture

What makes a good adherent cell expansion system for cell and gene therapy? There is a great need for adherent cell expansion systems...

Aren't suspension systems good enough? Adherent cells are the backbone of recent biotechnology innovations that work towards a...

The bioprocessing industry’s manufacturing capacity crunch Imagine a world where chronic diseases such as heart diseases, cancers, or...