At 53Biologics, we understand that securing a reliable supply chain is critical for your operations. Our microbial cGMP production facility specializes in producing high-quality recombinant proteins using E. coli, P. pastoris, and other microbial hosts.
With over 15 years of experience and a portfolio of more than 100 proteins, including enzymes, antibodies, and growth factors, we are well-equipped to support your product development and 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.
Availability & Quick Turnaround
No queue project initiation and fast-tracking ensure you get your products faster
Extensive Experience
Over 15 years in microbial protein production with a proven track record in developing and manufacturing more than 100 proteins
Comprehensive Solutions
A one-stop-shop for protein production, from development to Fill & Finish, streamlining your operations
Manufacturing Capacities
Our facility’s hybrid design and 200L and 2000L fermenters support both small-scale and large-scale production, ensuring consistent supply
Quality Assurance
Tailored QC 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
At 53Biologics, we understand that advanced upstream processing (USP) capabilities are critical to driving successful outcomes for your projects. Our state-of-the-art facility with ISO 7 and 8 clean rooms is equipped with fermenters up to 200 and 2000L of stainless steel or single-use configuration, providing the scalability and flexibility needed to accommodate a wide range of microbial processes. We excel in supporting diverse expression systems and handling complex fermentation strategies, ensuring optimal yields and product quality.
We combine these capabilities with stringent 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 expertise.
Our state-of-the-art facility is equipped with advanced downstream processing (DSP) technologies in ISO 7 and 8 clean rooms, including 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 precision in delivering your pharmaceutical solutions.
In addition to our production capabilities, 53Biologics offers in-house Fill & Finish services that cater to your specific requirements. Whether you need vials, single-use bags or bottles, our filling line combines an isolator with both hand-filling and semi-automated filling, providing you with flexibility and reducing lead times.
For larger or more specialized projects, we collaborate with a network of trusted partners, all operating under stringent quality agreements to maintain the highest standards across every stage of production.
Our highly skilled technical team is dedicated to ensuring 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.
“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!
