MVIC FAQ

Welcome to the MVIC FAQ - the place where you get answers to your questions

Here we will regularly publish answers to frequently asked questions that we believe interest others than just the questioner.

We are looking for a commercial entity that can perform pre-clinical PK/toxicological studies with an inhaled drug-candidate. Would this be in MVIC´s range of services?

We are a CRO based in Sweden focused on the development of inhaled drugs for various diseases. This includes pre-clinical and tox studies.

We are a drug discovery biotech company currently underway to develop an inhalable anti-inflammatory peptide solution targeting asthma/COPD diseases. We are looking for in-vivo asthma/COPD animal models and came to learn of MVIC's expertise in the field. We wanted ask whether MVIC is experienced with 'Microsprayer aerosolizer' in preclinical studies?

MVIC is a CRO specialized in the field of inhalation and we do R&D in all aspects including pre-clinical, CMC, and clinical. We have asthma/COPD models and use various ways to deliver compounds including microspraying. How do we proceed? Could you please outline somewhat more about what you want in a mail? Please also include some information about your company as the available information on your homepage is somewhat limited in English. I then suggest we set up a CDA (Confidentiality agreement) and then a TC.

With this email, we would like to establish the cooperation based on your Inhalation products for China Market. In particular, we are interested in MVIC’ s platform from development of inhalation products. And in MVIC’ s on-going projects that are open for partnership and intended for the Chinese market. We will be very interested to discuss any collaboration possibilities.

MVIC is a dedicated inhalation CRO (Contract Research Organization) supporting the development of inhalation products. As a CRO, we do R&D as a service and we work globally. We have many experts with long experience, and we have our own laboratories. We do not have any products of our own – we develop products for you.

Please find attached our requirements for Bioequivalence studies: could you please check this document and let us know whether you believe MVIC can support us with such studies?

MVIC is very well equipped and has a long experience to do the studies you request. We have done these studies for other customers, and we are well aware of both FDA and EMA guidelines. In addition to the standard tests, we can also do spray pattern/plume geometry as well as laser diffraction when applicable. We have an automated dose fire station for both MDIs and nasal devices.

Our company has a proprietary dry powder multi-dose device and want to develop a generic product. What services does your company have related to this?

Supporting this kind or request is a key expertise area of MVIC. After de-engineering of the reference product, we develop a strategy and perform formulation development up to about 1 kg scale which is used in the first PK equivalence study. MVIC can manufacture clinical material at GMP quality for such a study.

I am reaching out on behalf of a CMC consulting company helping our clients from exploratory work to first in man. One of my clients is looking for a subcontractor able to provide pre-formulation services for an oral/pulmonary administration of a molecule that is poorly soluble. Would this be in MVIC’s range of services?

We are a CRO that is focussed on various aspects on respiratory delivery. We are very well suited to do pre-formulation activities as well as pre-clinical, toxicological and first-time-in-man studies. We are particularly well suited to do formulation development aiming for different product groups including e.g. products containing APIs that are poorly soluble.

How is a project with MVIC initiated?

Please describe your problem to us, in as much details as possible. We then create a CDA between our two companies followed by more detailed discussions about the way forward (mails and/or TCs). When we come that far, we will add relevant colleagues being experts in various areas. When we have agreed what to do, MVIC creates a quote for you from which you can order. We then do the job and report to you.