ABOUT US

Global experts in biopharmaceutical development and manufacture

THE COMPANY

We’re a vertically integrated biotechnology company

With over a decade of experience, mAbxience is a global biotech company dedicated to the development and manufacture of biologics, supporting access to high-quality medicines.

We provide end-to-end services in the B2B biopharmaceutical space, ensuring everything we deliver worldwide is world-class. From R&D expertise in biologics, specialized in biosimilars, to our agile and flexible CDMO (Contract Development and Manufacturing Organization) services, we tailor solutions to meet our partners’ needs.

FACILITIES

State of the art GMP multi-product plants in Europe and South America

We incorporate cutting edge technology in our development and manufacturing platform across three Biologic Drug Substance (BDS) facilities and our partner filling sites. Our facilities are spread across two continents, with single-use bioreactors offering a combined capacity of 50,000L and great flexibility, from R&D batches to commercial batches.

Genhelix site | Spain

Up to 24.000L Cell Culture Capacity

  • 1st line – 6 x 2000L
  • 2nd line – 3 x 4000L

Single-use technology in most plant processes

Fully independent small scale GMP production plant: 3L-200L. Ideal for clinical batches or small volume projects

GMP approval from regulatory agencies: FDA, EMA, Japan PMDA, Australia TGA, Canada, Saudi Arabia, COFEPRIS (Mexico), Russia, Turkish MoH, among others.

Garín site | Argentina

Up to 24.000L Cell Culture Capacity

  • 1st line – 6 x 2000L installed
  • 2nd line – 6 x 2000L (expansion to be completed 2Q 2024)

Line 2 under construction to be completely isolated from Line 1. Possibility to manufacture simultaneously two completely different products in the same site (e.g. mabs and vaccines).

Broad experience in monoclonals and vaccines, more than 200M doses of COVID adenoviral vaccine manufactured.

R&D center including small scale facility and pilot plant focused on process improvements and new technologies.

GMP approval from regulatory agencies: EMA, COFEPRIS (Mexico) and ANMAT (Argentina), among others.

Munro site | Argentina

Installed Capacity: 2 x 1000L

R&D center including small scale facility and pilot plant focused on process improvements, clinical batches and new technologies

Extremely flexible site with capacity to manufacture different biologic products

GMP approval from regulatory agencies: COFEPRIS (Mexico), Saudi Arabia, Jordan, Russia, ANMAT (Argentina), Turkey and Colombia, among others.

VALUES

Ensuring access to high quality biopharmaceuticals, worldwide

Our company was born from a desire to bring hope to as many patients as possible. We are also guided by a quality philosophy that permeates everything we do. We are committed to producing world-class biopharmaceutical products through optimized processes and by working closely with our partners.

LEADERSHIP TEAM

Directing a multidisciplinary team of 1000+ people

We are a company of over a thousand passionate and committed professionals supported by an experienced management team.

Esteban Corley

Argentina Director

Ayman Ibrahim

Global Head, Regulatory Affairs & Pharmacovigilance

Timo Liebig

Chief Scientific Officer R&D

Susana Millán

Medical Director

Diana Morales

Chief Financial Officer

Francisco Olivera

Global Operations Director

Claudia Ponce

Quality Director

Teresa Tavares

Head of Legal

Silvia Uzuriaga
Silvia Uzuriaga

HR Director

Jurgen Van Broeck

Global Commercial Director

OUR STORY

From lab to life: over ten years of experience in biologics

From our beginnings as biosimilar specialists in Argentina, to our rapid worldwide expansion and the launch of our CDMO platform, discover the story of mAbxience.

  • GMP: Good Manufacturing Practices

  • EMA: European Medicines Agency

  • FDA: US Food Drug Administration

  • GGBA: Global Generics & Biosimilar Awards

2010 – 2012
2014 – 2015

  • Genhelix: mAbxience Spain R&D center

  • First launch of MB01 rituximab (Novex®, Argentina)

2016 – 2017

  • First launch of MB02 bevacizumab (Bevax®, Argentina)

  • “Biosimilar Initiative of the Year” Award 2016 by GGBA.”

  • EMA GMP certification granted to mAbxience Spain

2018 – 2019

  • Partnered worldwide with MB02 bevacizumab biosimilar

  • “Business Development of the Year” Award 2018 by GGBA

2020 – 2021

  • EMA approval for MB02 bevacizumab biosimilar

  • Manufacture of the AstraZeneca/Oxford Covid19 Vaccine

  • Garin: mAbxience Argentina new state-of-the-art biomanufacturing facility

  • MB02 bevacizumab Global Regulatory submission

  • Launch of CDMO services

2022 – Present

  • FDA & PMDA approval for MB02

  • EMA & FDA inspection at mAbxience Argentina and León respectively

  • Expansion of Spanish R&D center at Genhelix

  • Launch global CDMO platform strategy to all partners worldwide

  • Fresenius Kabi acquires a majority stake in mAbxience, joining Insud Pharma as shareholders