Manufacturing services

Production of non-GMP batches under aseptic conditions

 Production of non-GMP batches under aseptic conditions

Coriolis is the expert in formulation development for liquid and lyophilized drug products. During pre-clinical development phases, non-GMP drug product batches are often required for e.g., toxicological studies (TOX batches) or indicative stability studies. Coriolis offers the manufacturing of liquid and lyophilized products in a large variety of formats and batch sizes.

Liquid drug product manufacturing

In our R&D facilities, we utilize modern automated filling equipment (Flexicon FCP50 including LAF by Franz Ziel) capable of processing all common vial formats and covering a broad range of batch sizes from a few dozen to several thousand. For special container formats (such as prefilled syringes, safe-lock tubes, cryotubes), for small batches (e.g., for reference materials) and products up to BSL2 / S2, we also offer flexible semi-automated or manual filling solutions.

Lyophilized drug product manufacturing

Coriolis has a strong expertise in developing lyophilization processes and perform scale-up and robustness testing. Our dedicated lyophilization development center includes a range of modern freeze-dryers from lab to production scale, equipped with comprehensive process analytical tools. We offer manufacturing of lyophilized drug products in all common vial formats and prefilled syringes, covering a broad range of batch sizes from a few dozen to several thousand (freeze-dryers from 0.5 to 6 m2 shelf area).

We can produce the following batch sizes

 

Liquid drug products Lyophilized drug product

2R – 15,000 vials/day

6R – 8,000 vials/day

10R – 8,000 vials/day

20R – 4,000 vials/day

25R – 4,000 vials/day

2R – 19,000 vials/cycle

6R – 10,000 vials/cycle

10R – 8,000 vials/cycle

20R – 5,000 vials/cycle

25R – 4,000 vials/cycle

 

Drug product analytics and stability testing

As a development company with a strong focus on analytical characterization of biopharmaceuticals, we offer a large portfolio of specialized analytical techniques. Based on the project requirements, we offer a tailored analytical testing regiment for your liquid or lyophilized drug product batch – including a customized batch manufacturing record. We also perform stability and forced degradation studies under virtually any storage condition or simulating a large variety of stress conditions under R&D and GMP. Read more

Do you have any questions?

Our experts are happy to discuss your questions and inquiries related to the supply of preclinical material.

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Production of your preclinical drug product

We offer the supply of preclinical material tailored to your specific drug product, development phase and primary packaging material, and is backed by many years of experience with similar products. Click on a product type to explore our entire portfolio of specialized development and analytical services.

Quality & biosafety level of this service

We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:

Our services related to the supply of preclinical material

The supply of preclinical material is often accompanied by our related services, such as formulation development, lyophilization process development and the development of analytical methods. 

Formulation development

Our formulation development services deliver biopharmaceutical drug products that are robust for manufacturing, storage, handling and administration to patients.

We develop formulations for liquid, frozen and lyophilized drug products that fit the needs of your molecule and development phase. In a unique collaborative approach, our experts concentrate on your target product profile (TPP) and tailor the study design to your requirements.

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lyophilization_development

Lyophilization process development

Lyophilization is a valuable alternative to liquid formulation to achieve a stable drug product for many fragile (bio)pharmaceutical drug substances.

In our dedicated lyophilization development center, we develop robust and economical freeze-drying cycles suitable for production and tailored to the requirements of your product and the needs of your development phase.

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analytical_methods

Development of analytical methods

A sensitive and orthogonal characterization of the drug product by using stability indicating and phase-appropriate analytical methods is important.

Our expert scientists operate over 100 different analytical techniques and are experienced in setting up dedicated methods specific for your drug product. We also perform method qualification and, in case of GMP equipment, also method validation or compendial method verification.

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Pure client orientation

Pure client orientation

As a privately held company, we are independent and accountable to nobody except you, our client. Therefore, we can provide our services with solely data-driven recommendations. With our collaborative approach and transparent communication strategy, you will always stay on top of the project. You will also benefit from the scientific excellence of our distinguished panel of scientific advisors. They are actively involved in the project strategy and discussions to provide their independent advice.

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Full flexibility and transparency

Full flexibility and transparency

In our know-how-based collaboration, we disclose to you all required information from work plans and methods to raw data and final results. We also support the transfer of methods, formulations and processes to you for further development and commercialization. With a free license (under any applied Coriolis background IP) and exclusive use of your results (under the foreground IP), you maintain your flexibility. Coriolis demands no royalties or milestone payments.

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Manufacturing services for molecules of biosafety level S1 and S2

Manufacturing services for molecules of biosafety level S1 and S2

Innovative drugs such as gene- and cell therapy products frequently utilize genetically modified organism or biological substances that fall under biosafety level S1 or S2. If you are working with genetically modified organisms, such as a lentiviral vector, we got you covered. In our manufacturing facilities, we handle liquid and lyophilized drug products up to biosafety level S2. With dedicated officers for biological and genetical safety, we take care of the biological safety assessment and regulatory paperwork to get project work stated as quickly as possible.

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Development services

Development services

“It is a medicine, not a molecule, that we are giving to the patient” Marc B. Brown, 2005.

Besides analytical services, Coriolis is the expert in developing liquid and lyophilized drug products for a large variety of different (bio)pharmaceutical molecules, including proteins, peptides, nucleic acids, ATMPs, GMOs, vaccines and virus(-like) particles.

Find out how we can support your drug development...

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Analytical services under R&D and GMP

Analytical services under R&D and GMP

We offer an impressive portfolio of analytical services for biopharmaceutical drugs and vaccines.

Our scientists are highly skilled in developing dedicated and robust analytical methods for your specific needs. We also maintain numerous in-house methods that can readily be applied to common sample types.

Get to know our analytical portfolio.

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Contact us

Contact us

Please contact Dr. Stefan Heindl for inquiries related to our manufacturing services

Dr. Stefan Heindl