aimofcontact:[<p>The goal of the discussion with Steffen Bira and Serra Gürcan from Corden Pharma was to gain insight into the design, stability, and practical application of lipid nanoparticles (LNPs) for use in gene therapy. The conversation focused on the possibility of using Corden Pharma’s LNP starter kits, understanding the factors affecting the stability of LNPs, and exploring options for incorporating antibodies into LNPs to target specific cells. </p>],
insights:[<p>Steffen Bira and Serra Gürcan of Corden Pharma[Link Corden Pharmahttps://cordenpharma.com/] indicated that our planned spray drying approach of LNPs has not been extensively explored within their operations. The company focuses primarily on the aseptic fill and finish of LNPs, particularly for injectable formulations. However, they acknowledged the potential for spray drying and recommended consulting with specialized companies to assess the feasibility.
The stability of the lipids used in LNPs during the spray drying process was also identified as an area requiring further investigation.
The stability of LNPs, in particular in the context of the shear forces encountered in inhalation therapy, was identified as a critical factor. Corden Pharma highlighted that while the stability of individual lipid components can be evaluated, the stability of a complete LNP formulation containing RNA or other payloads must be empirically tested. The company put forward the suggestion that cryoprotectants and varying temperature conditions might be considered to
enhance the stability of LNPs during processing. Corden Pharma outlined the process used to select the lipids included in their LNP starter kits, nothing that these combinations are based on established interactions and research findings, particularly in RNA-containing formulations. The kits are designed to facilitate the creation of stable LNPs by providing materials that have been tested for their physical-chemical properties, encapsulation efficiency, and potency. Furthermore, the company highlighted that a single LNP starter kit can be used for multiple batches, offering a practical solution for experimental work.
When asked about modifying lipid components within LNP formulations, Corden Pharma suggested that exploring alternative lipids and other components could be beneficial for improving stability and efficacy, depending on the specific needs of the project. We discussed the availability of various lipids, including derivatives of cholesterol, which might enhance transfection efficiency in certain cell types. Corden Pharma confirmed that it is also possible to incorporate antibodies into LNPs, either during the initial preparation phase or by incubating antibodies with formed LNPs to achieve surface localization.
While they did not have hands-on experience in this specific application, they referenced existing studies that could provide further guidance.
Corden Pharma clarified that their role as a Contract Development and Manufacturing Organization (CDMO) is focused on providing services
for the production of active pharmaceutical ingredients (APIs) and excipients, rather than developing therapeutic products. They advised that intellectual property (IP) considerations are crucial when selecting lipids for LNP formulations, especially in commercial applications, as many lipids are patented. Companies pursuing gene therapy projects should ensure that the lipids they choose are free from IP restrictions or be prepared to pay associated fees.
The possibility of establishing a collaborative relationship was discussed, with Corden Pharma open to the idea of offering discounts on LNP starter kits or other materials in exchange for recognition in publications or other forms of acknowledgment. This proposal is subject to internal approval and would be pursued further through direct communication. </p>],
implementation:[<p>The cooperation with Cordon Pharma provided invaluable insights for the project, particularly regarding the selection of lipids critical LNP stability and the potential applications of LNPs in gene therapy. Our initial approach involved utilising the Cayman kit, which proved to be suboptimal for the intended delivery of our Primeguide. The Corden Pharma kit #2 offers enhanced delivery efficiency thanks to its cutting-edge lipid components, including cationic lipids that boost cellular uptake and auxiliary lipids
that reinforce the LNP structure. However, we have subsequently updated our approach and now use the Corden Pharma Kit, which builds on these benefits by including even more optimised lipid formulations. This change allows us to further improve the robustness and stability of our LNP formulations. The insights gained from the survey will significantly influence our testing process and enable us to optimise the delivery of therapeutic agents and improve overall treatment efficacy. </p>],
heading:"Focus on adapting expression strategies for Fanzor nickases and exploring the potential of Pichia pastoris (SMD1163) for SpuFz1 nickase variants ",
job:"Representative body for severely disabled persons",
affiliation:"University Bielefeld",
pictureurl:pics['johannfunke'],
tag:"Academia",
heading:"",
heading:"urgent requirement for a hygiene concept for students with disabilities and immunocompromised employees ",
interviewtabid:"johannfunke",
cardtext:"",
quote:"",
aimofcontact:"",
insights:"",
implementation:"",
summary:""
quote:"The implementation of the hygiene concept is proving more difficult than expected due to the bureaucracy at the university. Nevertheless, the interview gave us a good insight into this labyrinth of regulations and we got started the prozess of implementation.",
quoteVorname:"Vera",
quoteNachname:"Köhler",
aimofcontact:[<p>We contacted the university because of the urgent need to address the issue of hygiene for students and staff, particularly those with immunocomprised students and staff. There was a need to develop an effective hygiene concept to ensure the health and safety of these people. We developed this concept in collaboration with Max, our CF friend. [Link] </p>],
insights:[<p>We learnt that our hygiene concept is very well-developed. But although a well-developed hygiene concept is already existing, strategic development and a step-by-step approach are needed. In particular, the step-by-step implementation was emphasized, like starting with equipping the toilets. Bureaucratic hurdles, such as the need to apply to the rectorate, were identified as a major challenge. In addition, it became clear that there is a great need for sanitary facilities and facilities for the disabled, especially due to the needs of students and staff with health problems. Interaction and networking with other universities was also considered valuable. </p>],
implementation:[<p>The next phase of developing a new hygiene concept is to maintain contact with Mr. Johannfunke in order to continue to advance the hygiene concept in collaboration. The strategic approach entails the incremental implementation of measures, exemplified by the establishment of the inaugural toilet facility within the main building. It is of the utmost importance to ensure the uninterrupted implementation of the hygiene concept. In order to achieve this, it is essential to draw upon the existing plans and measures that have already been implemented in new buildings. We are working on advancing the plans at a higher level and are in regular dialogue with the Central contact point Barrier-free in order to overcome bureaucratic hurdles and actively promote the topic. Furthermore, it is necessary to intensify lobbying work in order to gain greater support for this issue at both the university and political levels. </p>],
interview:<>
<QaBoxq="What do you think of our hygiene concept and our plan?"a="This is a very acute problem. It particularly affects students with disabilities and immune-compromised staff, such as those with cancer or cystic fibrosis, who are forced to work from home. The problem is: Employees can work from home, but students cannot. There is a great need for hygiene measures, as contact must be avoided to minimise the risk of infection."/>
<QaBoxq="What are the challenges in implementing the hygiene concept?"a="There is a lack of strategic development, although your hygiene concept is well developed. It is necessary to proceed in small steps, e.g. starting with a toilet in the main building. However, bureaucracy is a major obstacle. To be implemented, an application has to be submitted to the rectorate, and these processes are often lengthy and complicated."/>
<QaBoxq="What is the current situation at our university?"a="While some progress has been made with the installation of additional toilets and disabled-friendly toilets in new buildings, there is as yet no overarching strategy in place to guide future developments. Furthermore, the lack of clarity regarding the mission statement and objectives leaves room for ambiguity. The duty of care that employers have towards employees is established, yet the situation is regulated differently with regards to students. The possibility of receiving compensation for disadvantages is open, but is frequently seen as inadequate."/>
<QaBoxq="What are the next steps in implementing the hygiene concept?"a="It is essential that the concept be implemented in small, strategic steps. At the same time, it is vital that the rectorate and other decision-makers be consulted on a regular basis to ensure that this matter remains at the forefront of discussions. Furthermore, it is of great importance to engage in political lobbying to secure additional support for this issue."/>
</>
summary:"We got in touch because there was an acute hygiene problem for particularly vulnerable groups like immunocomprised persons at the university. We learnt from the exchange that despite a well-developed hygiene policy, strategic steps are still needed, especially to overcome bureaucratic hurdles. We have integrated these lessons into our project by focusing on continuous collaboration with the Central contact point Barrier-free and other decision-makers. "
