Biologics
End-to-end expertise for biologics facilities
End-to-end expertise for biologics facilities
At KeyPlants, we offer end-to-end solutions for the design, construction, and commissioning of biologics facilities, from initial concept to a fully operational and qualified facility. Our team of experts has extensive experience in process design, utility design, facility design, and project management, as well as in modular facilities.
One trend in particular is the increasing demand for smaller, more flexible facilities. This is driven by several factors, including the need for personalised medicine and more niche products, higher titers, regionalisation, supply chain risk mitigation, and sustainability. In terms of production steps, biologics typically go through cell culture and microbial fermentation processes, followed by downstream purification, formulation, and filling. In addition, viral vectors are used in gene therapy and other advanced therapies.
Our approach is to work closely with clients to develop solutions that meet their specific needs and goals, while ensuring that their facilities are flexible, scalable, and efficient. We specialise in modular facilities, which allow for higher predictability with regards to time schedule, cost, and quality. With our turnkey project delivery, clients can rest assured that their facility will be delivered on time, on budget, and to the highest standards of quality and compliance.
About Biologics
In terms of production steps, biologics typically go through cell culture and microbial fermentation processes, followed by downstream purification and formulation. Additionally, viral vectors are used in gene therapy and other advanced therapies.
When investing in biologics manufacturing facilities, companies should focus on flexibility, scalability, and sustainability. Modular facilities and pods offer higher predictability with regards to time schedule, cost, and quality. At KeyPlants, we specialize in designing and executing modular facility projects and pods to meet the specific needs of biologics manufacturers.
Production techniques for biologics drug substance
Production techniques for biologics drug substance
Biologics are drugs that are manufactured using living organisms such as mammalian and microbial cells, or gene therapy vectors. These are complex molecules that require advanced production techniques. Below are the main categories of production techniques for biologics drug substance:
1. Mammalian cell culture:
This is the most common technique for producing biologics, especially monoclonal antibodies. In this process, large-scale bioreactors are used to cultivate mammalian cells, which are genetically modified to produce the desired protein. This cell culture is then harvested and purified to obtain the drug substance.
2. Microbial fermentation:
This technique involves using organisms like bacteria or yeast to produce proteins like insulin and vaccines. The microorganisms are grown in large-scale bioreactors with a specific nutrient-rich medium. Afterward, the protein is extracted, purified and formulated.
3. Cell and Gene:
This technique involves genetically modifying human cells, including T-cells or stem cells, in a laboratory to express certain proteins or to repair a genetic mutation that results in disease. The modified cells are then grown and expanded using specialized lab techniques before being infused back into the patient.
4. Viral vector manufacturing:
This is a technique for producing viral vectors, which are used to deliver gene therapies, vaccines and immunotherapies. In this process, a virus or virus-like particle is modified for non-pathogenic purposes and then used to deliver therapeutic payloads into target cells.
- Regardless of the production technique, the main production process steps for biologics drug substance can be summarized as follows:
- Cell line development: optimization of specific criteria to generate productive cell lines
- Cell culture phase: where modified cells are grown in bioreactors, monitored, maintained and fed
- Harvesting: the product is separated from the cell culture
- Purification: the product is separated from the cell debris, media, and other contaminants
- Formulation: the product is formulated into final dosage form
In conclusion, biologics drug substance production techniques are categorized into mammalian cell culture, microbial fermentation, cell and gene therapy, and viral vector manufacturing. The main production process steps include cell line development, cell culture phase, harvesting, purification, and formulation.
Related Pages
