At the very beginning of 2021, at the midst of the Covid-19 pandemic, we assigned a contract developer for the company’s vaccine candidate against Chlamydia, and immediately thereafter initiated an intense work period of knowledge transfer. Biovian Oy, which is an internationally recognized CDMO and manufacturer with its own GMP facility, is developing an industrial manufacturing method and will manufacture study products for future trials, such as toxicological and clinical studies.

By moving to new facilities, we gained access to a combination of laboratory, office and conferencing which means that laboratory work is now easily made in-house – such as complementary and confirmatory studies along with evaluation of potential new candidates – with the office and representation area close at hand.

Following our growth strategy, Stephen was recruited to support our CMC development with his extensive experience. Partnering meetings were attended to and a large part of our time was dedicated to business development, where expansion of the portfolio had the highest priority.

We also had the pleasure to confirm both excellent T-cell and antibody responses as part of our preclinical development. These very promising results indicate that our vaccine candidate generates an effective barrier that can prevent infections and potentially lead to more effective healing of an infection that has started.

Several essential steps of progress were made in the development of an industrially scalable manufacturing process – which, will speed up our manufacture of study products to be used in the toxicological testing and forthcoming clinical studies.

Closing the year, we could announce that our work had attracted a competent investor, highly merited within our industry, who today is a major stakeholder of Eurocine Vaccines.

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Glossary

CDMO - Contract Development and Manufacturing Organisation, is an organisation that serves the pharmaceutical industry and provides clients with comprehensive services from drug development through manufacturing on an outsourcing base. https://en.wikipedia.org/wiki/Contract_manufacturing_organization

CMC – Chemistry, Manufacturing and Controls, is a set of crucial activities when developing new pharmaceutical products. Beyond the processes themselves, CMC also refers to practices and specifications that must be followed and met in order to ensure product safety and consistency between batches. For the Chlamydia project Biovian Oy has been selected as the CDMO within CMC. https://tmg.mgh.harvard.edu/services/chemistry-manufacturing-controls

CRO – Clinical Research Organisation, is a life sciences organisation that provides outsourced support to the pharmaceutical and biotechnology industries in the form of research services, trials and testing on a contract basis. https://en.wikipedia.org/wiki/Contract_research_organization

EMA – European Medicines Agency, is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Its equivalent in US is FDA. https://www.ema.europa.eu/en/about-us/who-we-are

FDA – US Food and Drug Administration, is a US administrative organisation responsible for protecting the public health by assuring the safety, efficacy, and security of human drugs. Its equivalent in Europe is EMA. https://www.usa.gov/federal-agencies/food-and-drug-administration

GMP – Good Manufacturing Practice, is a descriptive system for ensuring that pharmaceutical products are consistently produced and controlled according to quality standard that a medicines manufacturer must meet in their processes. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice

mRNA – Messenger RiboNucleic Acid, is a single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and is read by a ribosome in the process of synthesizing a protein. https://en.wikipedia.org/wiki/Messenger_RNA

T-cell – T Lymphocyte type of Leukocyte, also referred to as the white blood cell, is an essential part of the immune system. They are one of two primary types of lymphocytes—B cells being the second type—that determine the specificity of immune response to antigens (foreign substances) in the body. https://www.britannica.com/science/T-cell

As the world around us rapidly is returning to normal, the awareness of the need of safe and effective vaccines has made a persistent impact on our industry. Ground-breaking technologies, rapid drug development and higher level of collaboration between Pharmaceutical Industry and Authorities is our new playground. Besides, already now there is a struggle for talents on this emerging market space and, effective administration and readiness to respond to potential new pandemic threats will call for agile organisations.

Eurocine Vaccines responds to these changes by stepping-up its activities!

• First and foremost, we are building a strong portfolio. This is a highly time-consuming activity, scouting and evaluating innovations, which requires a thorough approach of combined pharmaceutical, legal, and business skills.
  
  
• Our ambition is to leverage our candidates beyond expectations, continuously looking for possibilities to broaden each of them. This can be made in many ways, such as;
  • finding new applications
  • offspring into other areas
  • enhancement through adjuvants
  • developing optional ways of administration
  • combining two or more vaccine candidates where applicable
  
  
• Since we strive for operational excellence, we have designed our organisation and processes to gear up on synergies. Our senior team has already now the necessary key competences and ability to run an additional number of projects and our lab is optimized for rapid testing. The already established extensive business network enables us to reach organisations and key individuals when and where necessary.

Read more how we Bridge the Gap =>