Biopharmaceuticals

How are biopharmaceuticals produced in bioreactors? What makes them different from traditional drugs made via chemical synthesis? What is the full technological route for producing a batch of biopharmaceutical products based on allogeneic MSCs?

Biopharmaceuticals are products in which active pharmaceutical ingredients (APIs) are living cells or substances produced by these cells in industrial culture bioreactors. Their manufacture harnesses natural processes of biosynthesis and cellular biochemistry, producing biologically active substances as a result. Such substances include therapeutic antibodies, hormones, growth factors – active pharmaceutical ingredients of biopharmaceuticals. Biopharmaceuticals are far more challenging to develop and manufacture than chemically synthesised pharmaceuticals.

Biotechnological production – due to the natural variability inherent to living organisms and the naturally occurring errors (mutations) – requires much greater in-process control (IPC) than traditional pharmaceutical production. Maintaining microbiological purity is particularly crucial, as it is impossible to perform terminal sterilisation on the product. The microbiological purity is ensured by a number of advanced technological solutions, as well as compliance with the Standard Operating Procedures (SOPs).

Bioceltix pharmaceutical manufacturing process involves isolation of primary stem cells from an eligible, healthy donor, subsequent purification through in vitro culture, and finally, cryopreservation of the mesenchymal stem cells, ready to be administered immediately after thawing without any loss of therapeutic potential.

How do we produce a batch of a medicinal product based on allogeneic stem cells and intended for veterinary use? What does the technological route look like at Bioceltix?

The route consists of nine stages:

  1. Assessment of the adipose tissue donating animal through a panel of tests (recommended for allogeneic stem cell production by the EMA).
  2. Pharmaceutical-grade isolation and in vitro culture of mesenchymal stem cells.
  3. In-process quality control (IPQC) using advanced analytical methods.
  4. Controlled cryopreservation of the finished product.
  5. Sterility testing in accordance the guidelines on sterile medicinal products.
  6. Release of the medicinal product batch by a qualified person.
  7. Storage and shipment of the biopharmaceutical in compliance with GDP (Good Distribution Practice).
  8. Pharmacovigilance.
  9. Continuous product quality improvement – applying new solutions to production and quality control.

Wrote about us

Puls Biznesu

Puls Biznesu about our plans: Bioceltix announces that it will soon debut on NewConnect – the company has recently completed the pre-IPO round. So far, the company has obtained a total of approx. PLN 20 million in financing for the development of a still innovative method of treating pets ...

Article

Forbes- Incredibles

Forbes about Polish start-ups in the coronavirus crisis: “The year 2020 was a big challenge for companies, individual sectors of the economy and probably all of us. In the coming weeks and months of 2021 it will be similar. The condition of start-ups is no exception here. it is easier and ...

Article

Investors’ Zone

According to the „Investors’ Zone”, an interesting year is being prepared on the stock exchange: “This year, an exceptionally large group of companies is choosing NewConnect. As many as 63 companies declared their willingness to enter the alternative market, and several more in the ...

Article

Portal Wrocław

Gazeta Wrocławska wrote about us: “Bioceltix is ​​working on innovative biological medicines used in the treatment of common autoimmune and inflammatory diseases in companion animals. The company from Wrocław has something to fight for. This is indicated by the numbers on the global drug ...

Article

Mam Startup – summary 2021

We create at Bioceltix veterinary biological medicines, and in 2020 we announced plans for a stock exchange debut and we obtained a permit from the Main Pharmaceutical Inspector to manufacture veterinary biological drugs. Despite the pandemic, we continue our projects without downtime. You can ...

Article