Cell Culture Manufacturing Process

Our autologous cell cultures are produced to the highest standards in the highest possible cleanroom class A. The cultivation and provision of keratinocytes are subject to strict regulatory requirements, which require the DIZG to maintain a separate cleanroom area just for them.

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1. COLLECTION/PREPERATION
- The DIZG collection kit is handed over to the clinic with biopsy tubes, documents and guidelines for collection.
- After collection, the biopsies are sent back to the DIZG.
- The biopsies are gently decontaminated before cell isolation.
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2. PROCESSING
- The cells from the biopsies are isolated and further processed within cleanroom class A, incubated in specially designed incubators at 37 °C and 5% CO₂.
- The growth and morphology of the cells are monitored microscopically.
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3. PREPARATION OF THE SHEETS FOR TRANSPLANTATION
- The sheets are cultivated until a fine skin develops. This takes around three weeks on average.
- During preparation, each sheet is detached and bound to a carrier.
- The finished transplants are sent refrigerated by a special courier.
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4. PREPARATION OF THE SUSPENSION FOR TRANSPLANTATION
- The keratinocyte suspension can be prepared for transplantation after ten (+/- two) days.
- The finished suspension is filled into syringes with a special nozzle-cap closure and dispatched.

1.1. Collection kit

1.2. Preparation of the biopsies

2.1. Processing the cells

2.2. Control of culture growth

3.1. Befestigung des Sheets an der Trägergaze

3.2. Dispatch of the sheets

4. Packaging/shipping of the suspension

DIZG
- About us
  The non-profit German Institute for Cell and Tissue Replacement (DIZG) is a pharmaceutical manufacturer based in Berlin and is one of the largest pharmaceutical and biotechnological non-profit organizations of its kind in Europe.
- Research & Development
  Optimizing transplant properties, adapting them to ever-changing clinical requirements, identifying new surgical applications for existing transplant types, and developing new transplants are what drive the Research & Development (R&D) team.
- Safety & Quality
  In Germany, human cell and tissue transplants of human origin are regulated as medicinal products and/or require approval. This means that their production, biological safety, and clinical application are subject to oversight by German authorities. In DIZG's cleanrooms, all regulatory requirements are strictly followed.
- Facility 2026
  The DIZG is investing in a new production facility for allogeneic devitalized tissue preparations to ensure safe patient care.
  From the groundbreaking in 2021 to the topping-out ceremony and beyond – discover the progress here.
- Press
  Here you can download interesting facts about DIZG, press releases, published interviews, literature as well as company images and logos.
- News
  Here you will find our news and the event overview.
Tissue donation
- All About Tissue Donation
  The tissue donations received by the DIZG originate from a living person or are collected post-mortem, i.e. after death. Under sections 3 and 4 of the German Transplantation Act, tissue removal, like organ removal, is only permitted with the consent of the donor or the relatives of the deceased.
- Living Tissue Donation
  The Tissue Donation department works closely with national and international collection facilities as well as with clinics that participate in living donation programmes. Together they ensure that human transplants are available for upcoming operations.
- Post mortem Tissue Donation
  Bone and soft tissue can be donated after death, i.e. post-mortem. However, according to the provisions of the Transplantation Act § 3 and § 4, the removal of tissue is only permitted with the donor's consent.
- Become a donor clinic
  The demand for safe human tissue transplants exceeds the supply. The more clinics participate in the DIZG donation programme, the more patients can be supplied with human transplants throughout Germany and Europe. This is why it makes sense to expand the tissue donation programme across the board.
  Since its foundation, around 868,000 transplants have been manufactured infection-free.
Allografts
- Application Areas
  We support doctors* and surgeons in their day-to-day clinical challenges with our versatile human allografts in form of tendons, menisci, bones and much more.
  Since its foundation, around 933,000 transplants have been manufactured infection-free.
- Allograft Portfolio
  The DIZG's transplant portfolio already includes 230 innovative human transplant forms for widespread clinical provision. Discover our comprehensive range!
- Meniscus Matching
  The DIZG is the only provider in Germany that offers meniscus matching to find a suitable meniscus transplant.
Cell Cultures
- Cell Culture: Areas of Application
  Autologous keratinocyte transplants are often an indispensable treatment method for extensive skin wounds and severe grade 2b and 3 burns. For more than 20 years, the DIZG has been the only institution in Germany to produce these in the form of sheets of human keratinocytes and a suspension of human keratinocytes.
- Cell Culture Manufacturing Process
  Our autologous cell cultures are produced to the highest standards in the highest possible cleanroom class A. The cultivation and provision of keratinocytes are subject to strict regulatory requirements, which require the DIZG to maintain a separate cleanroom area just for them.
- Cell Culture Service
  We offer you a comprehensive service for our autologous cell cultures, starting long before the transplantation. We also assist burn clinics in meeting regulatory requirements.