Leaders in Monolith Separation Technology

BIA Separations is the exclusive manufacturer of convective interaction media (CIM®) monolith columns that have been optimized to meet the research and production needs of the biotechnology industry.

Based on more than two decades of experience, BIA Separations has developed methods and products that are revolutionizing the purification of viruses for vaccines and gene vectors, as well as exosomes, plasmid DNA, nanoparticles, and plasma fractions. As an ISO-certified company, BIA Separations pursues the highest quality standards in its research, development, production, and customer service efforts. Additionally, the company uses its expertise in liquid chromatography to develop and validate analytical methods, plus design industrial purification processes.

After 20 years, BIA Separations remains the leading provider of monolith separation technology and strives to offer the best solutions for downstream processing and analytics with the purpose of saving time and effort for its customers, thus maximizing their return on investment.

Company Milestones:

1990

Aleš Štrancar, PhD, starts researching monolithic materials for biomolecular separation processes.

1997

Tubular shaped monoliths (with radial flow operation) are introduced.

1998

BIA Separations founded as a spin-off from BIA d.o.o. (founded in 1989). In the first few years, the technology is promoted mainly to the scientific community,  and the first product is developed. Company passes audits by Novartis, Boehringer Ingelheim, and Octapharma.

2001

BIA Separations and Boehringer Ingelheim announce cooperation in plasmid DNA manufacturing.

2002

First Drug Master File Number 15838 is established for CIM® DEAE monolithic supports. Analytical lab passes FDA inspection.

2003

Company attains ISO 9001 certification (Q-579).

2004

5th Anniversary of BIA Separations.

CIM monolith is chosen for industrial cGMP purification of plasmid DNA at Boehringer Ingelheim where it provides a 15-fold increase in productivity over non-monolithic process.

Company earns 2004 Frost & Sullivan Technology Leadership Award.  

First Monolith Summer School and Symposium organized in Portorož, Slovenia.

2006

Drug Master File Number 19695 is established for CIM® QA monolithic supports. First cGMP process is developed for a vaccine (influenza) using CIM technology.

Second Monolith Summer School and Symposium organized in Portorož, Slovenia.

2008

cGMP process is developed for an immunoglobulin M (IgM). Partnership is formed with Agilent Technologies to develop and produce analytical monolithic columns.

Third Monolith Summer School and Symposium organized in Portorož, Slovenia.

2009

Foundation cornerstone is laid for a research and production facility in Ajdovščina, Slovenia.

Company passes second FDA audit for one of its projects.

2010

CIM® SO3 Monolithic Supports receive Drug Master File.

Fourth Monolith Summer School and Symposium organized in Portorož, Slovenia.

2011

New production facility opens in Ajdovščina, Slovenia.

Analytical contract research laboratory approved by Agency for Medicinal Products and Medical Devices of the Republic of Slovenia and holds laboratory quality control authorization according to EU GMP Volume 4, Chapter 7 – Contract Manufacture and Analysis.

BIA Separations receives KAPPA-Health Award for being one of the most successful research-intensive and high-tech small to medium-sized enterprises (SMEs) in EU co-funded projects.

BIA Separations and JSR Corporation announce entry into a strategic partnership.

2012

New CIMmultus™ advanced composite column product line launched.

BIA Separations and Showa Denko K.K. (SDK) sign a strategic partnership agreement.

Fifth Monolith Summer School and Symposium organized in Portorož, Slovenia.

2016

Company launches PATfix™ for rapid “at-line” process analysis.

Seventh Monolith Summer School and Symposium organized in Portorož, Slovenia.

2018

BIA Separations celebrates 20 Years of Innovation.

Eighth Monolith Summer School and Symposium organized in Portorož, Slovenia.