53Biologics Production Plant

53Biologics Production Plant

53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing.

About the plant

The Production plant of 53Biologics has Process Development Labs and three different Manufacturing Lines.

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 53Biologics facility is tailored to deliver excellence at every stage.

Line 2 - Up to 200L cGMP Empowering precision in pharmaceutical manufacturing, our line 2 is meticulously designed to meet the highest standards of quality and compliance. It has fermenters from 20 to 200L at the Upstream grade D clean room for microbial and from 50 to 200L for mammalian. For the Downstream, this line has centrifuge and high pressure homogenization units to feed single use tangential flow filtration and chromatography equipments.

Line 3 - Up to 2000L cGMP At the forefront of large-scale biomanufacturing, our Line 3 is tailored for microbial culture, able to reach 2000L scale. This line is also equipped with centrifuge, high pressure homogenization equipments and single use tangential flow filtration and chromatography equipments to handle the demands of complex and high-volume productions, ensuring the delivery of top-tier pharmaceutical solutions.

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)

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Activity

• Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, LBP (Live Biotherapeutic Products), BIOLOGICS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification):
• DEA: N/A
• BSL: 1, 2
• 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, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Logistics, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, Storage, CMC regulatory support

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