BDI biotech Production Plant

BDI biotech Production Plant

We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

About the plant

BDI biotech is a Spanish company specialized in bringing ideas from bench to reality, working as an R&D department focused in strain and bioprocess development, scale-up and batches production. We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

Our facility count with Process Development Labs and a non-GMP production line up to 500L:

Process Development Labs

The Process Development Facilities are equipped with a variety of industrial solutions, including glass, stainless steel, and single-use bioreactors from 1 to 30L. All the different upstream scales, counts with the associate downstream like HPH, centrifuges, depth filtrations, TFF and chromatography equipment. This process development service is tailored to each client’s specific needs and can be conducted either prior to cGMP production launch or as part of technology transfer from the client’s facilities to ours. Our customer-centric approach ensures efficient, robust, and scalable process development, supported by cutting-edge facilities and equipment.

Line 1 - Up to 500L non-GMP

Our non-GMP production boasts versatile capabilities with a reactor of 100L and another one of 500L. Both with dedicated centrifuge, high pressure homogenization unit, filtration skids and holders, chromatography equipments, and auxiliary tanks. Whether you´re embarking on early-stage research or scaling up BDI biotech facility is tailored to deliver excellence at every stage.

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Certifications

• ISO

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Activity

• Peptide, protein, hormone & enzyme, LBP (Live Biotherapeutic Products), BIOLOGICS manufacturing

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Features

• Uses: Investigational, Preclinical
• Toxicity (OEB classification):
• DEA: N/A
• BSL: 1
• Therapeutic areas: N/A
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), Health Canada (Canada), MHRA (UK), TGA (Australia), ANVISA (Brazil), ANMAT (Argentina)

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Batch Size / Reactor

• Small, Medium, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Logistics, R&D, Process development, Process optimization, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Research batches, Scale-up, Pilot batches, Analytical methods development, Bioanalysis, Analytical methods transfer, Storage, CMC regulatory support

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