Our Services
All aspects of product development from concept to launch and support
Design inputs to establish the right product specifications
Jonas Molecular can assist in developing the appropriate product specifications using our knowledge and contacts in clinical microbiology. We can provide input to clearly define the “must-haves” and the “nice-to-haves” so that the right product comes to market; it’s important to remember that some improvements can be made after the product is on the market.
Source clinical specimens
It is important to obtain the right specimens for conducting research and development so that there are no surprises during the clinical studies for regulatory submissions. Jonas Molecular has excellent connections with commercial sources of clinical specimens as well as with clinical laboratories looking to partner with industry allowing us to assist in sourcing the correct samples for your studies.
Facilitation of collaborations with thought leaders
We have relationships with key opinion leaders and clinical microbiology laboratory directors in the US and abroad allowing us to facilitate introductions and potential collaborations. We are particularly well-connected with experts in pulmonary diseases, including tuberculosis, and clinical microbiologists.
Design of assay verification and validation studies including clinical trials
Understanding the experiments required to obtain regulatory approval is important. Vivian has experience in designing verification and validation studies of infectious disease molecular in vitrodiagnostic assays. She can assist in writing protocols and reports in support of the required studies.
Documentation including standard operating procedures
Jonas Molecular can assist with writing and developing SOPs and templates that aid in efficient product development. We can also help write verification and validation protocols and reports as well as regulatory submissions and pre-submissions.
Developing raw material, bulk reagent and kit specifications
The right specifications are critical to ensure that the correct product is made every time. Jonas Molecular has experience in establishing raw material specifications including making decisions about when to accept materials, including oligomers, on a certificate of analysis or when it’s necessary to perform additional quality control tests. We understand how important it is to establish bulk solutions mixing and hold time parameters. It’s also important to find the balance between enough testing and too much, including kit release.
“Vivian worked with the R&D team at Gen-Probe Cardiff when she was leading a product development team based in both San Diego and Cardiff, which spanned two continents and two time zones. The team in Cardiff was inexperienced in the product development process and had not previously worked within a larger team. Vivian is a highly experienced product development scientist and an excellent mentor of junior scientists. She was able to get the team functioning efficiently to deliver on its goals, by fully utilising the working time available, and creating a real team ethos across the whole team. She is very skilled at defining development goals and working with a team to help them achieve those goals.”
Dr Molly Price-Jones FRSB, Director Tybio Ltd (formerly Managing Director, Gen-Probe Cardiff Ltd)