BBI Solutions develops and produces reagents, antibodies, gold conjugates and lateral-flow tests for the diagnostics industry.
BBI Solutions
Crumlin (Wales, UK)New on Amplifa
About BBI Solutions
BBI Solutions is a provider of reagents for the in-vitro diagnostics (IVD) and life-sciences industries, headquartered in Crumlin (Wales, UK). The company develops and manufactures native and recombinant reagents such as enzymes, antibodies, antigens, gold colloids and gold conjugates as well as cell-culture reagents, human-serum and control materials, plus stabilizers, blockers and substrates. Its services include antibody development and manufacture up to 5 g (roller-bottle and hollow-fibre bioreactors), biomolecule fermentation up to 5,000 L, gold conjugation with over 600 custom projects per year, and contract manufacturing of lateral-flow tests in ISO-13485-certified cleanrooms – from pilot lots to series in the millions. BBI also supports customers with formulation, troubleshooting and regulatory approval matters. According to its own statement, the company can look back on around 70 years of experience in reagent development and supplies customers worldwide.
- Site
- NP11 3EF Crumlin
- Processes
- Antibody development (antigen mapping, hybridoma generation, screening, subcloning, purification), Biomolecule production (gene screening, fermentation from pilot to production scale, purification), Gold conjugation (coupling of antibodies, antigens or oligos to gold nanoparticles), Lateral-flow contract manufacture (striping, laminating, cutting, assembly in cleanrooms), Antibody development, Antibody manufacture (up to 5 g, roller-bottle/hollow-fibre bioreactors), Product customization (enzymes, antigens, catalogue reagents; fermentation up to 5,000 L), Gold conjugation (>600 custom conjugations/year, batch up to 24 L at OD10)
- Materials
- Gold (colloid/conjugates), Enzymes, Antibodies, Antigens, Cell-culture reagents, Human serum & control materials, Stabilizers, blockers & substrates
- Certificates
- ISO 13485
- Industries
- IVD (in-vitro diagnostics), Life sciences, Lateral-flow diagnostics, Autoimmune diagnostics
- 01
Gene screening / antigen mapping
- 02
Antibody development (hybridoma generation, screening, subcloning)
- 03
Fermentation / cell culture (roller-bottle, hollow fibre, up to 5,000 L)
- 04
Purification and characterization
- 05
Gold conjugation
- 06
Formulation / customization
- 07
Lateral-flow contract manufacture (striping, laminating, cutting, assembly)
- 08
Regulatory support and release documentation
Products & Processes
Antibodies
Development and manufacture up to 5 g in roller-bottle or hollow-fibre bioreactors including purification and conjugation.
Antigens
Native and recombinant antigens for IVD assays, also available as custom manufacturing.
Enzymes
High-activity enzymes, among other things for the production of glucose test strips.
Gold (colloid/conjugates)
Ultra-uniform gold nanoparticles (≤8 % CV) as markers for lateral-flow tests, batches up to 24 L at OD10.
Cell-culture reagents
Cell-culture reagents available as catalogue products.
Human serum & control materials
Serum and control materials for assay development and quality assurance.
Stabilizers, blockers & substrates
Formulation components for the stabilization of test strips and assays.
Locations
Crumlin
GBHeadquarters / Production
- Lot size
- Pilot lots to several million units
- Materials
- Enzymes, antibodies, antigens, gold colloids and conjugates
- Roller-bottle systems
- Hollow-fibre bioreactors
- ISO-13485 cleanrooms
- Automated lateral-flow production lines (striping, laminating, cutting, assembly)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Antibody development (antigen mapping, hybridoma generation, screening, subcloning, purification)Engineering | – | – | – | – | Antibodies |
| Engineering | – | – | 5 g | – | Antibodies |
| Biomolecule production (gene screening, fermentation from pilot to production scale, purification)Engineering | – | – | – | 5,000 L | Enzymes, Antigens, Reagents |
| Gold conjugation (coupling of antibodies, antigens or oligos to gold nanoparticles)Engineering | ≤8 % CV | – | – | 24 L at OD10 | Gold nanoparticles |
| Lateral-flow contract manufacture (striping, laminating, cutting, assembly in cleanrooms)Assembly | – | – | – | Pilot lots – several million units | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Hollow-fibre bioreactor | – | – | – | – | – |
| Roller-bottle system | – | – | – | – | – |
| Automated lateral-flow production lines (striping, laminating, cutting, assembly) | – | – | – | – | ISO-13485 cleanrooms |
Additional services
Quality
BBI Solutions is ISO 13485 certified; production takes place in certified cleanrooms with QC to ensure sensitivity, specificity and batch consistency. Product documentation (release documents) is available online without login.
| Evidence | Crumlin |
|---|---|
| ISO 13485 |
History
- ca. 1970er
Start of reagent development – according to the company, active in this field for around 70 years