PRODUCTS & SERVICES

Bacthera is offering integrated end-to-end development and manufacturing services, 100% dedicated to the Live Biotherapeutic Product industry. Put simple, Bacthera is your one-stop-shop CDMO for all Live Biotherapeutic Product development and manufacturing needs. We are integrating the development and supply of drug substance and drug product, from early-stage development up to commercial supply of your Live Biotherapeutic Product. Supported by product-specific analytics, we thereby ensure a de-risked CMC development to our customers, which is aiming at successful future commercialization right from the beginning of our customer’s journey.

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Strain Intake & Cell Banking

Every project starts with taking new strains into Bacthera’s facility. Not only does our team perform a detailed analysis and characterization of the strains, they also act as a core function to ensure that our staff can perform all project work safely and in accordance with occupational and environmental regulations. Once identity and safety have been proven, our teams transfer customer cell banks into our facilities and provide a smooth transition of the strains into the GMP production.

Bacthera’s Strain Intake & Cell Banking teams are essential for Bacthera’s quality and EHS strategy. To protect our employees and our customer’s products within our facilities, our teams are conducting an in-depth identification and risk assessment of each new strain that shall enter our production facilities. In close collaboration with our customers, we transfer customer’s cell banks into our facility and guarantee a smooth transition into the world of GMP production. This step is supported by the production of high quality, GMP compliant master and working cell banks, including testing and characterization to release for drug substance production.

Strain Intake & Cell Banking services provided by Bacthera:

– Strain risk assessments

– Cell banking (master/working/research cell banks)

Get in touch with us to learn more on how our Strain Intake & Cell Banking teams support your CMC development.

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Development

With the overall aim of establishing a robust and scalable production process for commercialization in mind, Bacthera offers integrated development services throughout the process chain of Live Biotherapeutic Products.

By utilizing the right know-how and technologies, we ensure that the development of our customers products result in a production process which is suited for GMP production, scalable for commercial volumes, low in complexity and cost-efficient. From sourcing of the raw materials to the final drug product, we ensure that the CMC aspect of our customer’s Live Biotherapeutic Product development journey will not become a roadblock throughout the project.

Together with our customers, we establish a target product profile and are developing the production process towards it. The development of the drug substance and drug product formulations and processes go hand in hand together with the analytical development of the product. The integration of the different areas of development allows Bacthera to enhance control over the product characteristics and result in a more targeted outcome for our customers. In combination with state-of-the-art high throughput screening technologies, Bacthera provides accelerated development timelines to its customers and the industry.

Development services provided by Bacthera:

– Proof of concept studies (e.g. drying technologies or capsules)

– Drug substance up- & downstream process development

– Drug product process development

– Analytical development

– Integrated development

– Manufacturing of drug substance/drug product material for toxicological/animal studies

Get in touch with us to learn more on how our development services de-risks and support your CMC development.

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GMP Manufacturing

From clinical trial material supply to commercial manufacturing, Bacthera offers Drug Substance and Drug Product GMP production services of Live Biotherapeutic Products.

Our production sites in Denmark and Switzerland are designed to produce Drug substance and Drug product material for clinical trials and small-scale commercial supply. In combination with Bacthera’s world-class technologies, we further enhance the yields of the production processes and ensure continuous supply of our customer’s projects.

In addition to supply for clinical trials, Bacthera offers commercial manufacturing of Live Biotherapeutic Products out of Lonza’s manufacturing site in Visp, Switzerland. Integrated in one of the most modern biologics sites of the world, Bacthera offers tailor-made and purpose focused commercial manufacturing solutions or production in Bacthera’s multi-purpose manufacturing suite. The manufacturing plant is envisioned to be operationally ready by the end of 2023.

GMP manufacturing services provided by Bacthera:

– Drug substance & drug product clinical trial material supply for phase I – III

– Integrated manufacturing

– QC release

– Commercial manufacturing

Get in touch with us to learn more on how we can support the commercial launch of your Live Biotherapeutic Product.

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Packaging

After production of the drug product, Bacthera offers fully automated and semi-automated packaging in aluminum blisters under anaerobic conditions.

As important as manufacturing Drug Substance and Drug Product is the question: How do I pack and store my Live Biotherapeutic Product? As Live Biotherapeutic Products are living organisms, the packaging and the storage of the product is an absolute essential aspect of the development of a Live Biotherapeutic Product. Bacthera is offering aluminum-aluminum blister packaging to work under anaerobic conditions to retain the product’s viability. With the support of external partners, Bacthera can also support clients with secondary packaging and randomization for clinical trials or serialization for commercial products.

Packaging services provided by Bacthera:

– (Semi-) automated blister packaging (alu/alu)

– Packaging under nitrogen blanket

– Secondary packaging, serialization and randomization provided by external partners

Get in touch with us to learn more on how our packaging services can support the viability and stability of your Live Biotherapeutic Product.

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