Bacthera offers a range of technologies for the Live Biotherapeutic Product industry that supports and de-risks the CMC development of our customers. The challenges in Live Biotherapeutic Product manufacturing are manifold. Independently if it is strains that have to be handled in a strict anaerobe environment, drying processes that results in loss of cell viability or strains that are sensitive to the human’s gastric acid. Bacthera’s innovative and scalable technology platforms help our customers to overcome any kind of challenge in Live Biotherapeutic Product manufacturing and delivering viable product to the desired target site.
Media & Cryo
Bacthera maintains an extensive media and cryo library. Combined with our expert know-how and high-throughput screening technology, we are well-equipped to find the best raw material composition and process conditions for our customer’s strains.
Development of fermentation production processes for Live Biotherapeutic Products can be challenging and the composition of the chosen media and cryo compositions have a major impact on the yield, viability, and characteristics of the resulting drug substance. Our customers benefit from Bacthera’s vast experience in developing high-yielding, scalable and GMP ready media and cryo compositions. With the ultimate goal of commercialization of our customer’s products in mind, and thereby bringing life changing treatments to patients all over the world, our team ensures that the right choice of media from the beginning of a product’s development, will result in a cost-efficient, scalable and robust production process.
Get in touch with us to learn more about how the right choice of media and cryo compositions can support your CMC development.Contact us
Anaerobic Process Conditions
Bacthera’s equipment is designed by purpose for handling of strict and facultative anaerobic strains. Combined with our vast experience and expertise to handle such strains, our customers can expect that their product will be handled under the appropriate environmental conditions, which results in a high viable cell count of their product.
Some bacterial strains, especially the ones that have been derived from the human gut, often do not survive when exposed to oxygen. To access their full therapeutic potential, these strains need to be produced under full anaerobic conditions. At Bacthera, our full production chain is fully closed and ensures handling of each process step under full anaerobic conditions. With that we ensure that the strains remain viable until they reach their targeted destination inside the gastrointestinal tract.
Get in touch with us to learn more on how anaerobic process conditions can support your CMC development.Contact us
Spray Drying Technologies
Scalable, cost-efficient, fast, automated and viability retaining; nothing less is what Bacthera’s Live Biotherapeutic Drying drying technologies are designed for. With superior process properties compared to other drying technologies, Bacthera is offering industry enabling solutions for its customers.
Drying of Live Biotherapeutic Products remain one of the biggest challenges in Live Biotherapeutic Product manufacturing. Current industry standards such as freeze drying & milling often result in loss of viability and yields. In addition, the scalability, process times and the cost-efficiency of these processes are limited. Bacthera offers innovative spray drying technologies specially designed for Live Biotherapeutic Products that addresses these challenges and provide solutions for viability retaining, scalable, automated and cost-efficient drying technologies.
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Bacthera’s innovative capsule technology marks a milestone in Live Biotherapeutic Product delivery. The capsule that has been designed and developed by Lonza is intrinsically enteric, thus provides gastric-acid protection without the need to band and coat the capsule.
Delivering Live Biotherapeutic Products to the gastrointestinal tract is one of the key challenges for microbiome therapeutical products. As many strains are acid sensitive, many Live Biotherapeutic Products do not survive the passage through the human stomach. All industry standards to overcome these challenge result in multiple process steps (banding of capsules & coating), do not show full enteric properties or are not well suited for Live Biotherapeutic Products (pressing into tablets). Bacthera has access to the world’s only intrinsically enteric capsule developed and designed by Lonza, that allows safe passage of the Live Biotherapeutic Product through the stomach into the gastrointestinal tract, without any further processing of the drug product after the encapsulation.
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One of the most important aims of GMP manufacturing of Live Biotherapeutic Products is to produce a well-characterized product that meets the required target specifications. Bacthera is well-equipped to offer a variety of analytical methods and other Quality Control services to its customers.
To characterize Live Biotherapeutic Products, Bacthera has established state-of-the-art analytical methods in it’s manufacturing facilities, specifically designed for Live Biotherapeutic Products. Combined with the vast experience of Bacthera’s analytical team, GMP requirements can be fulfilled and customers will receive the product at highest quality standards and specifications.
Get in touch with us to learn more on how our analytical development team can support your CMC development.Contact us