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BIA Separations

Ajdovščina, SI

BIA Separations is the leading developer and manufacturer of CIM® (Convective Interaction Media) monolithic chromatographic columns for production, purification, and analytics of large biomolecules. BIA Separations has research, production and sales facility in Slovenia and sales offices in the US and China. Our mission is to develop and produce CIM® monolithic columns of highest quality and provide superior research and method development services for purification and analytics of biomolecules.

BIA Separations was founded by a group of scientists and venture capital investors in 1998. Their common purpose was to become the world leader in innovative biochromatography by developing monolithic materials for preparative applications. Based on more than 15 years of experience, BIA Separations has developed a wide range of CIM Convective Interaction Media® monoliths that address the growing need for powerful and... Show more »

BIA Separations is the leading developer and manufacturer of CIM® (Convective Interaction Media) monolithic chromatographic columns for production, purification, and analytics of large biomolecules. BIA Separations has research, production and sales facility in Slovenia and sales offices in the US and China. Our mission is to develop and produce CIM® monolithic columns of highest quality and provide superior research and method development services for purification and analytics of biomolecules.

BIA Separations was founded by a group of scientists and venture capital investors in 1998. Their common purpose was to become the world leader in innovative biochromatography by developing monolithic materials for preparative applications. Based on more than 15 years of experience, BIA Separations has developed a wide range of CIM Convective Interaction Media® monoliths that address the growing need for powerful and timesaving solutions in therapeutic biomolecule purification. Through both internal initiatives and external collaborations, this ISO certified company pursues the highest quality standards in its research, development, production, and customer service efforts. Additionally, BIA Separations uses its expertise in liquid chromatography to develop and validate analytical methods and design industrial purification processes. We are committed to providing our customers with the most reproducible and innovative products to meet their current and future separation needs.

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BIA Separations has not listed any services.

Viral Vector Purification
Price on request

BIA Separations offers downstream method development for extraction/purification of clinical-grade plasmid from E.coli biomass using chromatographic monoliths as a core technology.
- The process consists of one prechromatographic steps, followed by one or two chromatographic steps.
- At least 5 times higher productivity compared... Show more »

BIA Separations offers downstream method development for extraction/purification of clinical-grade plasmid from E.coli biomass using chromatographic monoliths as a core technology.
- The process consists of one prechromatographic steps, followed by one or two chromatographic steps.
- At least 5 times higher productivity compared to classical chromatographic downstream process for plasmid DNA due to usage of convective flow chromatographic media.
- Efficient plasmid DNA isolation from biomass with overall yield of the process being often higher than 50%
- Efficient separation of sc and oc plasmid DNA isoform. Final product with more than 90% of sc pDNA isoform
- Simple scale-up of the process up to 8 L column, enabling isolation of 40 g of pDNA per chromatographic run.
- Isolation of mg and up to several grams of plasmid
- Efficient plasmid DNA purification with very high yields (in some cases approaching 90%)
- OPTIONAL: Separation of supercoiled (sc) and open circular (oc) plasmid DNA isoform. Final product with more than 90 % of sc isoform
- We are able to process small and large plasmids (up to 30 kbp)
- Low impurity concentrations in final product: endotoxin level (˂10 EU/mg pDNA), genomic DNA (˂10 µg/mg pDNA), RNA (not visible on electrophoresis gel) and protein (˂5µg/mg pDNA) impurities.
- Formulation of the product in the buffer of choice

Requirements:
- E.coli biomass with total plasmid content of at least 10 mg provided by the customer
Note: for research use only, shipment included

Price: on request

References:
- Preparation of Pharmaceutical-Grade Plasmid DNA Using Methacrylate Monolithic Columns. F. Smrekar, A. Podgornik, M. Ciringer, S. Kontrec, P. Raspor, A. Štrancar, M. Peterka. Vaccine 28 (2010) 2039–2045
Chromatographic purification of plasmid DNA on hydrophobic methacrylate monolithic supports. S. Cardoso, U. Černigoj, N. Lendero Krajnc, A. Štrancar. Separation and Purification Technology 147 (2015) 139–146
BIA Separations is the leading developer and manufacturer of CIM® (Convective Interaction Media) monolithic chromatographic columns for production, purification, and analytics of large biomolecules. By now, several industrial processes producing gene therapy products are using CIM technology, since it offers high efficiency, high speed, and high yield in downstream processing.

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CIM Monolithic Columns
Convective Interaction Media Monolithic Columns
Price on request

CIM® monolithic columns stand for elaborate design providing high efficiency, high speed, and high yield in downstream processing of viruses, VLP, phages, pDNA and large proteins. Large flow-through channels and high surface accessibility of binding sites entail binding capacities exceeding those of resin-based columns and rapid... Show more »

CIM® monolithic columns stand for elaborate design providing high efficiency, high speed, and high yield in downstream processing of viruses, VLP, phages, pDNA and large proteins. Large flow-through channels and high surface accessibility of binding sites entail binding capacities exceeding those of resin-based columns and rapid mass transfer based on convection. CIM® monolithic columns are distinguished for their flow independent performance, resulting in fast separation, concentration, purification, removal, and analytics of your biopharmaceuticals. CIM® monolithic columns are available in different product lines to suit your different needs.

The BIA Separations Technical Support Group consists of experts, committed to care for the customer, in the field of biochromatography and CIM® monolithic columns. The main task of this reliable and responsive group is to support your needs concerning CIM® technology and help you with any kind of problem regarding the development of chromatographic methods, purification processes, or installation of CIM® monolithic columns. Customer assistance is provided via email, phone calls, Skype, or on-site technical support.

BIA Separations also offers customers the opportunity to have an on-site or off-site customized training in our technology and/or method development. Whether you require a general overview of our technology for either research or cGMP production or would like to have a more focused application-based training on pDNA, virus, or other molecule production, we can prepare a tailor-made program that will meet your requirements.

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Downstream Processing
Price on request

Starting from capture step to final polishing and formulation of your biomolecule (pDNA, DNA, proteins, pegylated proteins, bacteriophages, viruses, etc.).
Depending on your product and requirements the multistep process includes chromatographic media selection and optimization, virus inactivation, filtration, tangential flow... Show more »

Starting from capture step to final polishing and formulation of your biomolecule (pDNA, DNA, proteins, pegylated proteins, bacteriophages, viruses, etc.).
Depending on your product and requirements the multistep process includes chromatographic media selection and optimization, virus inactivation, filtration, tangential flow filtration.
As a matter of course the development of Downstream Processing goes hand in hand with analytical monitoring of target molecules and impurities.

Process Development
Let us do the work for you – we help you out if you lack time, equipment or experience on a certain biomolecule. Our highly skilled team has more than 2 decades of accumulated knowledge in Downstream Processing and Analytics of large biomolecules. Comprehensive analytical services for various types of molecules are provided by our Contract Research Team.

Based on your sample material and needs we provide:
1. Development of Downstream Processing
2. Development of HPLC analytical methods
3. Development and validation of various analytical methods

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HPLC Method Development
Price on request

For in-process and final product control (PAT) using CIMac analytical columns.
The development of analytical method is accompanied by a thorough characterization of your sample.

For in-process and final product control (PAT) using CIMac analytical columns.
The development of analytical method is accompanied by a thorough characterization of your sample.

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Antibody Immobilization
Price on request

Immobilization of antibodies (Abs) onto the chromatographic support is far from being a straightforward task. If you lack knowledge and skills, BIA Separations can do the work for you.
We offer:
Development and optimization of immunoaffinity chromatographic columns, based on CIM monolithic technology. Different options are... Show more »

Immobilization of antibodies (Abs) onto the chromatographic support is far from being a straightforward task. If you lack knowledge and skills, BIA Separations can do the work for you.
We offer:
Development and optimization of immunoaffinity chromatographic columns, based on CIM monolithic technology. Different options are possible:
- Orientation of immobilized Ab: oriented and non-oriented immobilization;
- Density of immobilized Ab: high-ligand and low-ligand density of immobilized Abs;
- Column size: 0.1 mL up to 8 L columns possible
- In addition to the immobilization service test with antigens provided by the customer can be performed.

Detailed description of the immunoaffinity chromatographic columns, based on CIM monolithic technology

Immunoaffinity adsorbents consist of chromatographic support, where monoclonal antibody (mAb) or polyclonal antibodies are irreversibly linked to. Immobilized antibodies selectively bind their antigen, which is applied to such column together with all the impurities. Using an appropriate elution mobile phase, the antigen could be selectively and with high recovery and biological activity recovered from the column. Immunoaffinity and affinity chromatographic columns, 96-well plates, spin cartridges could be extremely useful in specific diagnostic applications as well as in downstream processes, where a specific antigen is studied.
BIA Separations has a large experience with preparation of immunoaffinity-based chromatographic monoliths with the following features:
- high utilization of immobilized antibody, consequently high binding capacities for an antigen, usually larger than 1 mg/mL
- high recovery of antigen from the column (large quantities of pure antigen could be obtained);
- flow-independent chromatographic properties (fast analyses);
- reusable sorbent (multiple analyses possible);
- possibility of scale-up immobilization (from 0.1 mL sorbent volume to 8 L sorbent volume);
- different formats possible (analytical columns, 96-well plates, preparative columns).

Requirements:
- The pure antibody in the concentration of at least 2 mg/ml dissolved in buffer needs to be provided by the customer for free.
- For high ligand density immobilization a minimum 15 mg of antiboy per mL support needs to be provided by the client while low ligand density requires 5 mg antibody per mL of chromatographic support.
- Antigen testing is optional, carried out upon receiving a suitable quantity of antigen from the client (shipped at own expense).

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Analytical Method Development
Price on request

Method development, validation and verification, transfer and routine testing of pharmaceutical samples and biomolecules.

Method development, validation and verification, transfer and routine testing of pharmaceutical samples and biomolecules.

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Equipment
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Chromatography
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Purification Services
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Analytical Chemistry Services
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Chemistry and Materials
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Process Consulting
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Project and Process Management
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Biology
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Biochemistry & Molecular Biology
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Protein Services
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Antibody Services
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Nucleic Acid Services
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DNA Services
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Plasmids and Vectors
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Liquid Chromatography
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