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At 53Biologics, we understand that securing a reliable supply chain is critical for your operations. Our microbial cGMP production facility specializes in high-yield, reproducible manufacturing of enzymes and ancillary reagents using E. coli, P. pastoris, and other microbial hosts, ensuring consistent quality and performance across every batch.
We can either develop the strain from scratch or produce a MCB/WCB from your RCB including testing, release and storage.
Flexible manufacturing capabilities from small scale (up to 200L) to big scale (up to 2000L).
True flexibility in dosage forms and containers, whether you need vials, single-use bags or bottles in accordance with EU GMP Annex I.
Complete analytical support including in-process control, quality control, and stability studies to ensure product quality.
With over 15 year s of experience and a portfolio of more than 100 protiens produced, we are wll-equipped to support your manufacturing needs. Our facility operates with 200 L and 2000 L fermenters, ensuring that we can scale production to meet your demands, from development to full-scale production. Our facilities are specifically designed for enzymes, growth factors and other ancillary reagents.
Our facilities are specifically designed for enzymes, growth factors and others ancillary reagents.
+15
years of microbial experience
+100
recombinant proteins produced
2000L
maximum fermentation capacity
Quick Turnaround
No queue project initiation and fast-tracking ensure your enzyme and eragents are delivered on time.
Experience in Microbial
+10 years of experience with E. coli, Pichia and others microbial hosts with +100 recombinant proteins produced.
Comprenhensive Solutions
A one-stop-shop solution for protein production, from development to Fill & Finish and secondary packaging.
Manufacturing Capacities
200L and 2000L ferementers supporting both small and large-scale production, ensuring consistent supply.
Quality Assurance
Tailored manufacturing options (GMP. GMP-like, ISO 13485,non-GMP) to meet your specific regulatory needs.
Competitive Pricing
We offer cost-effective solutions, ensuring you receive the best value without compromising on quality.
Secure reliability on high-quality protein supply for your production needs. Contact us today!
53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
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