mAbxience Research S.L

mAbxience Research S.L Contract Manufacturing & Development (CDMO) Profile

mAbxience is a leading biotechnology company with 14+ years of experience in the development, production, and commercialization of biopharmaceuticals to treat life threatening conditions. Our mission is clear: to make high-quality medicines affordable and accessible across the globe – worldclass, worldwide. In 2022, Fresenius Kabi acquired a majority stake in mAbxience from Insud Pharma, making itreinforcing its position as a global, vertically integrated company.

With two market-approved biosimilars and a robust development pipeline of both innovators and biosimilars, mAbxience has established B2B presence in 100+ markets through a network of over 30 partners and built a team of 1,000+ highly qualified professionals. Our state-of-the art multi-product manufacturing facilities in Spain and Argentina have obtained GMP approval from renowned regulatory authorities, including FDA, EMA and PDMA.

mAbxience also harnesses its extensive biologics experience to provide reliable, patient-centric CDMO services to our pharma partners and expedite the clinical journey and launch of life-saving medicines. We leverage our operational excellence, highest quality standards, and advanced technologies to deliver agile and cost-effective development and GMP manufacturing solutions. To date, mAbxience has manufactured 3 commercial products (soon to be 7) and has supported multiple clinical programs.

In a nutshell:
• World-class biologics CDMO services through 14+ years experience in the development, manufacture, and launch of biopharmaceuticals.
• Patient-centric: our mission is to make high quality medicines accessible to all. World-class, worldwide.
• State-of-the-art cGMP multi-product facilities in Spain and Argentina with modern single-use equipment and identical configuration.
• Total of 48,000L mammalian cell culture capacity.
• Flexible scales (2L to 4000L SUBs) to rapidly adapt to changes in supply demand.
• cGMP pilot plant with 200L SUB for clinical and small-scale production.
• >95% batch success rate.
• Integrated operations. Highly efficient and fast technology transfer by dedicated and skilled MSAT teams in each site.
• R&D Center of Excellence in Spanish site.
• Lean structure to provide agile and cost-effective services.
• Solid supplier management system guarantees supply continuity.
• Strong process and analytical development capabilities;ambr15 and ambr 250, robust process and product characterization technologies.
• Highest GMP regulatory standards strictly followed. 15% of our employees are experts dedicated to quality and compliance.
• More than 20+ worldwide GMP certifications and inspections successfully completed by renowned regulatory agencies, such as FDA, EMA, PDMA and TGA.
• Manufacture of the Bulk Drug Substance for AstraZeneca/Oxford’s Covid19 Vaccine: virtual tech transfer completed in 3 months, 240 million doses successfully delivered within 15 months.
• Possibility to manage end-to-end services including Drug Product manufacturing and packaging with established partners.

WHAT MAKES US UNIQUE:
– Manufacturing excellence: integrated operations (R&D, MSAT, QC, Production in the same site)
– Due to our experience in biosimilars development, agility and cost effectiveness are in our DNA
– Scale flexibility to adapt to supply demand
– Fastest tech transfers in the industry
– Dual manufacturing: identical configuration and equipment (6 x 2000L SUBs) in production facilities
– Extensive experience with multiple regulatory agencies worldwide, 15% of our workforce is dedicated to quality/reg affairs/compliance

CDMO Services:
Biologics Liquids; Lyophilized amps/vials; Pre-Filled Syringes (PFS) Analytical Development; Cell Line Development; Formulation Development; ICH Stability Testing; Process Development Antibodies; Fusion Proteins; Recombinants + other Proteins; Protein Vaccines; Viral Vector Vaccines

Year Founded: 2009

Head Office: Madrid, Spain

Number of Facilities: 45415

Facility locations: Europe; South America

Website: Visit the mAbxience Research S.L website

Linkedin: Connect on Linkedin