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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.
With over 15 years of experience and a portfolio of more than 100 proteins, we are well-equipped to support your manufacturing needs. Our facility operates with 200L and 2000L fermenters, ensuring that we can scale to meet your demands, from development to full-scale production. Our facilities are specifically designed for enzymes, growth factors and others ancillary reagents.
No queue project initiation and fast-tracking ensure your enzyme and reagent batches are delivered consistently and on time.
Over 15 years in microbial protein production with a proven track record in developing and manufacturing more than 100 proteins.
A one-stop-shop for protein production, from development to Fill & Finish, we offer end-to-end solutions for enzymes and ancillary reagents.
Our facility’s hybrid design and 200L and 2000L fermenters support both small-scale and large-scale production, ensuring consistent supply.
Tailored QC options (GMP, GMP-like, ISO 13485, non-GMP) to meet your specific regulatory needs.
We offer cost-effective solutions, ensuring you receive the best value without compromising on quality
Our state-of-the-art facility with ISO 7 and 8 clean rooms is equipped with stainless steel bioreactors up to 200 and 2000L. This allows us to provide the scalability and flexibility needed for enzymes and ancillary reagents manufacturing. We excel in supporting diverse expression systems and handling complex fermentation strategies, ensuring optimal yields and product quality.
We combine these capabilities with adaptable quality standards, offering GMP, GMP-like (ISO 13485), and non-GMP production options, so you can be confident that every stage of your process is handled with the highest level of quality.
Our state-of-the-art facility is equipped with advanced downstream processing technologies in ISO 7 and 8 clean rooms. This includes centrifuges, high-pressure homogenizers, single-use tangential flow filtration systems, and single-use chromatography equipment. These cutting-edge tools enable us to handle a wide range of purification challenges, from standard processes to complex and specialized purifications.
Whether you require routine production or intricate, customized purification strategies, our expert team ensures the highest level of efficiency and reproducibility in delivering your enzymes and ancillary reagents.
Our highly skilled technical team is dedicated to ensure the success of your projects. With over 15 years of experience in process development, we excel in overcoming challenges and optimizing production processes.
Our no-queue project initiation policy and proactive problem-solving approach mean that we can quickly adapt to your needs, accelerating your time to market without compromising on quality. When you partner with 53Biologics, you gain access to a team that is committed to delivering on-time, every time.
In addition to our manufacturing lines, 53Biologics offers in-house Aseptic Fill & Finish services. A production area designed in accordance with Annex 1 allows us to offer true flexibility in dosage forms and containers, whether you need vials, single-use bags or bottles.
We speciallize aseptic filling of biological products including enzymes, ancillary reagents, vaccines,... maintain the highest standards across every stage of production.
“We partnered with 53Biologics because of their swift response and ability to meet our stringent standards. Their technical team is exceptional in overcoming challenges” – Clinical Operations Manager from a big biopharmaceutical company
Secure the same reliability 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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