The pandemic has impacted many areas of life, including the development, market launch, and production of essential medicines. The demand for equipment and consumables for manufacturing monoclonal antibodies, viral vectors, and other biopharmaceutical products has increased significantly. Many pharmaceutical companies have faced shortages in single-use biotechnologies (Single-Use, SUS) and equipment for biomolecule isolation and purification (Downstream).
Vaccine Production
The development and large-scale production of COVID-19 vaccines have been the primary drivers of the recent surge in demand for biotechnological equipment, consumables, and raw materials.
Scientists worldwide are working on vaccines developed and produced using various technological platforms, including:
- Inactivated vaccines
- Vector-based vaccines
- DNA/RNA vaccines
- Recombinant protein vaccines
Each platform has its advantages and disadvantages in terms of efficacy and application, as well as unique production process requirements. Depending on the type of cell culture used for biomass production and the antigen molecule, specific upstream equipment and various downstream purification approaches may be required.
One popular method for creating COVID-19 vaccines involves adenoviral vectors carrying immunodominant pathogen antigens. This genetic engineering approach eliminates the need for live viruses or bacteria in vaccine production, reduces development time, and accelerates the creation of new vaccines. Adenoviral vectors naturally enter human cells, triggering both humoral and cellular immune responses.
The HEK 293 cell line is commonly used to produce adenoviral vectors. Studies describe culturing HEK 293 cells in roller bottles and various bioreactor systems. Recent data suggest that wave and vertical bioreactors with single-use bags yield the best results in terms of productivity and scalability.
The preference for single-use bioreactors (over traditional stainless-steel fermenters) in adenoviral vaccine production (including COVID-19 vaccines) is easily explained. Traditional fermenters rely on aggressive mixing mechanisms (e.g., turbine or Rushton impellers), which are safe for thick-walled cells but can damage animal cells (such as HEK 293) that lack cell walls. In single-use (SUS) systems, gentler mixing and controlled gas supply minimize cell damage.
Additionally, animal cell cultures often require longer cultivation periods, increasing contamination risks. Given the high cost of culture media and final products, manufacturers prefer single-use systems to avoid batch losses due to contamination or residual inhibitors (e.g., from cleaning agents). For high-value products, single-use solutions may extend to all process stages—media preparation bags, filtration systems, and chromatography columns.
Monoclonal Antibody Production
The development and sale of monoclonal antibody (Mab) drugs represent one of the fastest-growing segments of the pharmaceutical market. In Russia, 90% of Mab drugs are still imported, highlighting significant potential for domestic biopharmaceutical growth.
Mab-based drugs are widely used in immunotherapy and immunodiagnostics for malignant diseases. Today, they are indispensable for diagnosing blood cancers, assessing patient immune status, and monitoring treatment efficacy. Tumor-specific antibodies help identify cancer cells in biopsy samples.
Purification Requirements
- Diagnostic use: 70–95% purity
- Therapeutic use: Higher purity required
Purification involves sequential affinity and ion-exchange chromatography. Common ion exchangers include diethylaminoethyl (DEAE) cellulose, Sepharose, or acrylamide granules. Affinity chromatography uses antigen-coupled resins.
Additional steps include:
- Viral inactivation to neutralize pathogens
- Gel filtration (agarose, Sepharose, or Sephadex columns) to remove impurities and concentrate the final product
Solutions from BRS Biotech
With deep expertise and extensive experience in biotech projects, we offer equipment and consumables under our own brand and from Chinese partners. To meet growing Russian demand for SUS technologies, we rapidly launched production of wave bioreactors and single-use bags, showcased at Pharmtech&Ingredients 2021.
Upstream Equipment
- Wave bioreactors (up to 200 L)
- Vertical bioreactors with single-use bags
- Transport containers and mixers
- Single-use bioreactor and mixer bags
Downstream Equipment
- Tangential Flow Filtration (TFF) systems
- Normal Flow Filtration (NFF) systems
- Capsule filters
- Filter holders
- Cassette filters
- Lab, pilot, and industrial chromatographs
- Chromatography columns
