What is the role of lyophilizates in COV-19 logistics?
Freeze-dried vaccines against SARS-CoV-2
The current Covid-19 pandemic poses great challenges for the world. The situation should be controllable with global vaccination programs, but it will require an enormous logistic effort in terms of transport, storage and administration of the vaccines. How can freeze-dried vaccines simplify these processes?
Vaccines against SARS-CoV-2
Newly developed and approved vaccines against SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) are intended to restrict the effects of the Covid-19 pandemic worldwide. The technologies used to develop vaccines differ: Recombinant proteins, viral or bacterial vectors, virus-like particles (VLPs), nucleic acids (e.g. DNA, RNA) and inactivated virus-based vaccines are already in use or are currently going through the approval process .
Challenges in global vaccine logistics
Global vaccination programs are necessary to control the pandemic situation. This includes sophisticated logistics for the manufacture, transport, storage and distribution of the vaccines. A constant cold chain ensures the stability and immunogenicity of the vaccines. This often requires low to very low temperatures. For example, RNA-based vaccines are stable for 6 months at -20 °C (Spikevax, Moderna Biotech) to -70 °C (Comirnaty, Pfizer/BioNTech). Viral vector vaccines are stable for 6 months at 2–8 °C (Vaxzevria, AstraZeneca). Maintaining the cold chain is an enormous economic and logistical effort and is responsible for 80 % of the costs of vaccination programs in developing countries .
Freeze-drying (lyophilization) improves the stability of the active ingredient and has been an established process in vaccine production for years. Freeze-dried RNA is stable for 10 months at 4 °C with the addition of cryoprotectants, and is activated when it is dissolved in solvent (reconstitution) [3-5]. The advantages of lyophilization also support the development of thermostable generation of vaccines against SARS-CoV-2. Various research institutions and manufacturers are currently developing lyophilized, RNA-based vaccines that can be stored at 2–8 °C for several days [6-9].
Reconstitution of lyophilized active agents
Lyophilized vaccines are often very laborious to reconstitute with needles and syringes. This can contaminate high-quality vaccines or cause needlestick injuries to medical staff. To avoid these risks, high-quality adapters such as the nextaro® premium transfer system from sfm medical devices GmbH are already used in many pharmaceutical areas. nextaro® dissolves lyophilized active agents gently and reliably before administration. It has a modular structure and can be adapted to the particular requirements of the active agent (as well as to different vial diameters) in order to optimize the reconstitution process. The result is a high-quality solution of the active agent that is ready for injection.
Aboul Fotouh K et al. AAPS PharmSciTech 2021; 22: 126-126.
Chen X et al. Journal of controlled release 2011; 152: 349-355.
In recent years, sustainability has become increasingly important in the medical industry. In particular, companies are increasingly focusing on the development and manufacture of sustainable medical products.
Freeze-drying (lyophilization) is one of the most important pharmaceutical processes. It ensures the shelf life and storability of sensitive drugs. In which areas are freeze-dried active ingredients preferred and which medication groups are suitable for this process?
Freeze-drying has proven to be effective for preservation in the manufacture of sensitive biopharmaceutical products. The requirements of this complex process are high. Lyophilized active ingredients have several advantages. What are they, and what factors need to be considered during reconstitution?