Assays

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News

November 28, 2017
New Article BioProcess International October 2017 - HCP Assay (Analysis)
September 8, 2017
End-of-the-Year discount on Polyclonal Antibodies!

A big Thank You to all of our customers, business partners and friends for the very successful collaboration over the past years.

Please see the related newsletter!

We are looking forward to get in contact with you.

 

 

 

July 25, 2017
The 25th Anniversary of BioGenes!

We are very proud to celebrate the anniversary.Please see our anniversary press release!

We are very exciting to celebrate the 25th anniversary of our company!

A big Thank you to all of our colleagues, customers, business partners and friends for the long-term and very successful work and collaboration.

We are looking forward to further prosperous years. 

Please see the anniversary press release below!

 

 

Press Releases

December 12, 2017
BioGenes establishes Scientific Advisory Board

 

BioGenes Establishes Scientific Advisory Board

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:

  • Prof. Dr. Hans Henning von Horsten, Industrial Biomanufacturing, HTW-Berlin University of Applied Sciences, Berlin
  • Prof. Dr. Frank F. Bier, Dept. Biosystems Integration and Process Automatisation, Fraunhofer IZI-BB, Potsdam-Golm
  • Dr. Wieland Wolf, CEO ProBioGen AG, Berlin
  • Dr. Jens Knauer, Method Development Virology Testing Quality Control, IDT Biologika GmbH, Dessau-Rosslau

The Scientific Advisory Board will provide BioGenes with significant expertise and experience throughout the whole drug development and manufacturing value chain to help strengthen and extend the Company’s position in the field of quality control for biopharmaceuticals.

Dr. Alexander Knoll, Managing Director of BioGenes states: “We are pleased to welcome these renowned experts to BioGenes’ Scientific Advisory Board. Creating the SAB represents another important step forward for the Company. Its members bring a wealth of experience in the area of biomanufacturing and analytics and will provide crucial advice based on their specializations which will be essential to guide us in prioritizing and driving forward our goals.”

Prof. Dr. Hans Henning von Horsten is co-inventor of several patents and pending patent applications for the biomanufacturing business. He was among the key inventors of ProBioGen’s GlymaxX antibody engineering technology that was outlicensed to Boehringer-Ingelheim, Novartis, Thermo-Fisher Scientific and several other drug developers. Hans Henning von Horsten is also Head of the Working Group Biotechnology at the Berlin-Brandenburg branch of the VDI Association of German Engineers.

Prof. Dr. Frank F. Bier is the founder of the Molecular Bioanalytics branch of the Fraunhofer Institute for Biomedical Engineering (Fraunhofer IBMT). In 2003, he was appointed Chair of Applied Bioelectronics and Biochip Technology at the University of Potsdam. Since 2014 he is the Head of the Department Biosystems Integration and Process Automatisation of the newly formed branch Fraunhofer Institute for Cell Therapy and Immunology, Biotechnology and Bioproduction (Fraunhofer IZI-BB) in Potsdam-Golm, Germany.

Dr. Wieland Wolf is the CEO of ProBioGen, an internationally operating Contract Development and Manufacturing Organization (CDMO). He has three decades of experience in the biopharmaceutical industry. Wieland Wolf was involved in pioneering product registrations at Bioferon GmbH, headed a production unit for API and parenteral dosage forms at the same company, and was responsible for the biotechnology division of the Rentschler Group, which he led through its transformation from a product-oriented enterprise into an established service provider and contract manufacturing organization (CMO). Wieland Wolf is the President of the European Association for Pharma Biotechnology and a member of the Board of Trustees of the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB) in Stuttgart, Germany.

Dr. Jens Knauer has a strong background in GLP/GMP contract research, method development and as a Principal Investigator in several clinical trials. Before joining IDT Biologika GmbH, he was involved in the development and validation of immunological assays at the Fraunhofer Institute for Cell Therapy and Immunology where he was also instrumental in building a GLP laboratory for immuno-toxicological assays.


About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.


Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

 

July 25, 2017
BioGenes Celebrates 25 Years of Excellence in Quality Control of Biotherapeutics

Berlin, Germany, July 25, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production, is celebrating its 25-year anniversary. In 1992 the scientists Dr. Alexander Knoll and Dr. Sergej Ovodov set out with a vision to provide services and kits for the quality control of biotherapeutics. Over the course of the last 25 years, BioGenes’s vision has become a reality. BioGenes has grown from a small niche start-up firm providing antibody services to a worldwide leading provider of host cell protein (HCP) assays, customized ELISA development and analytical services.

Company founder and CEO Dr. Alexander Knoll remarked: "This is an incredible milestone for our company. The company has achieved this success through the hard work, passion, and dedication of our team members and our culture of customer service that exists throughout the entire organization. I’m proud to say that our teams consistently exceed client expectations by providing the most efficient, and proactive services to each and every project.”

"To this day BioGenes is still driven by the entrepreneurial spirit of our founders, which has enabled us to constantly expand our offering portfolio," said Dagmar Schwertner, Marketing & Sales Director, who has been with the company for 23 years. "In the fall, BioGenes will be launching a new product for immunogenicity testing.” As of today, BioGenes’ offerings include:

  1. Customized ELISA Development
  2. Multi-product (platform) and specific HCP assays
  3. Generic HCP ELISAs (360-HCP assays for CHO cells and E.coli)
  4. Customized Antibodies (incl. anti-idiotypic antibodies)
  5. Analytical Services (2D DIGE, 2D Western Blot, HCP coverage determination etc.)

In its 25 years, BioGenes has delivered thousands of projects to our customers.  Find out more about BioGenes at www.BioGenes.de.

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

Contact
Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

November 10, 2015
BioGenes Announces Management Buy-out to Underpin Growth and Innovation Agenda

Berlin, Germany, November 10, 2015 / B3C newswire / - BioGenes GmbH, a global leader in host cell protein (HCP) assay development and a recognized partner of pharmaceutical companies all over the world, today announced that it has acquired all outstanding shares from its existing shareholders GUB Unternehmensbeteiligungen GmbH & Co. KGaA and VC Fonds Berlin GmbH for an undisclosed price. The management team consisting of the two founders Dr. Alexander Knoll and Dr. Sergej Ovodov have taken over these shares in a management buy-out (MBO). The acquisition has been finalized on 31 October 2015.

Dr. Alexander Knoll, Managing Director of BioGenes said: "We are delighted to have reached an agreement with the previous shareholders and we would like to take the opportunity to thank them for their loyalty. With their support, BioGenes has been growing strongly over the last years. The MBO will support our future growth strategy by driving innovations for customers and building new strategic partnerships with the aim to further expand our market position as a leader in host cell assay development."

Dagmar Schwertner, Marketing Director of BioGenes said: „BioGenes is known as a trusted and experienced expert in immunoassay, 2D electrophoresis and antibody development and we intend to continue systematically down the path we have started on. High quality standards throughout the whole value chain will of course be ensured in the years ahead.”

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long- term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

Contact
Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

October 27, 2015
BioGenes Launches Enhanced Generic E.coli Host Cell Protein Assay for Biomanufacturing

Berlin, Germany, October 27, 2015 / B3C newswire / -- BioGenes GmbH, a global leader in host cell protein (HCP) assay development, today announced that it has launched a generic HCP assay with improved HCP recovery properties for E.coli cells. The E.coli|360-HCP ELISA allows sponsors and biotech companies to postpone the development of a cost-intensive specific HCP assay until a more informed decision on the success of a biologic in development can be made.

The E.coli|360-HCP ELISA has been developed using the 360-HCP ELISA approach. While traditional generic HCP assays provide just one single antibody that must work for all processes the generic 360-HCP ELISA provides several kits, each using a different anti-HCP antibody so sponsors can try multiple antibodies to find the one that works best for their samples. An upfront performance test identifies the most suitable ELISA kit thus allowing to greatly increasing HCP recovery.

Dagmar Schwertner-Knoll, Marketing Director of BioGenes GmbH said: “We have evaluated the new generic HCP ELISA for E.coli extensively. For all samples tested we found that at least one of the four kit types was superior to the competitor kit.”

E.coli|360-HCP assay is based on W3110 and BL21 (DE3) cell lines which were fermented in different culture media and temperatures resulting in four antigen preparations with distinct HCP patterns. By immunizing goats with these antigens, BioGenes has developed a panel of four different HCP ELISAs that together build up the enhanced generic E.coli|360-HCP assay.

For all four assay types the lower limit of detection (LOD) is between 0.2–0.5 ng/ml and the lower limit of quantification (LOQ) is 0.6–1.6 ng/ml with a working range between 2–100 ng/ml. A high specificity for the antigen in all four assays was determined by 2D western blotting with the respective antibodies.

The E.coli|360-HCP ELISA will be presented at booth 422 at the BioProcess conference held on Oct 26-29, 2015 in Boston, MA, USA.

About BioGenes GmbH

 

BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

 

 

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

October 15, 2015
Gyros to Use 360-HCP Antibodies from BioGenes for Gyrolab™ Host Cell Protein Kits

Berlin, Germany, and Uppsala, Sweden, October 15, 2015 / B3C newswire / – BioGenes GmbH, a global leader in host cell protein (HCP) assay development, and Gyros AB, a pioneer in miniaturizing and automating immunoassays at nanoliter-scale, announce a cooperation for use of BioGenes' 360-HCP antibodies in Gyrolab™ CHO-HCP Kits 2-5. The four Gyrolab™ CHO-HCP Kits, which have been introduced recently, quantify host cell proteins from Chinese hamster ovary (CHO) cells and are used in biomanufacturing processes.

360-HCP antibodies from BioGenes have been developed according to a novel approach and stand out by their ability to cover the broadest possible spectrum of antigens. 360-HCP antibodies have been generated by immunizing different species combined with an optimized antigen and antibody preparation as well as purification strategy resulting in several antibody preparations. Thus each Gyrolab™ CHO-HCP Kit contains antibody preparations that have been generated in different species using slightly different antigens.

Gyros' kits are validated for use on the nanoliter-scale microfluidic systems Gyrolab xP workstation and Gyrolab xPlore which are in use in GLP and GMP environments in most of the top biopharma and CROs across the world. Primarily, BioGenes has developed the 360-HCP antibodies for its enhanced generic CHO|360-HCP ELISA. Through the collaboration with Gyros the 360-HCP antibodies can now also be used in in high-throughput analyses.

The new Gyrolab™ CHO-HCP Kits will be showcased at BPI 2015 on 26-29 October in Boston, MA

About BioGenes GmbH

 

BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is anexperienced and reliable partner for process development improvements in all areas of quality control, diagnostics anddrug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance andanimal welfare. The Company maintains long-term relationships with research institutes, universities and biotech andpharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company hasbeen evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

 

 

About Gyros

Gyros manufactures laboratory instruments, consumables, kits and software to maximize laboratory productivity byminiaturizing and automating immunoassays at nanoliter-scale. Gyrolab™ systems use proven microfluidic CDtechnology to analyze large numbers of samples in parallel, ensuring uniform processing and yielding up to 112 datapoints in less than one hour. Gyros will put a new spin on what’s possible in your laboratory.

 

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

February 3, 2015
BioGenes Establishes Distribution Network for Generic Host Cell Protein (HCP) Assay in Major Markets

Berlin, Germany, February 3, 2015 – BioGenes GmbH, a global leader in host cell protein (HCP) assay development, today announced that it has signed long-term agreements with distributors in USA and Canada, India, Japan and Middle/South America to offer its enhanced generic HCP assay CHO|360-HCP ELISA within their respective territories. Europe and the rest of world (ROW) will be served by BioGenes directly. 

CHO|360-HCP ELISA greatly improves the detection of HCPs in CHO cells by employing differently prepared host cell protein antigens and antibodies from two species. CHO|360-HCP ELISA allows users for the first time to easily choose the antibodies that work best for a specific process.

Dagmar Schwertner, Director of Marketing at BioGenes stated: “We are excited to partner with these premier distributors who will introduce CHO|360-HCP ELISA to their esteemed customer base. The distribution agreements will help leverage BioGenes’ sales and marketing capabilities to establish CHO|360-HCP ELISA as the preferred generic assay for HCP detection in CHO cells. BioGenes will be working closely with its distributors to ensure a high standard of service.”

About BioGenes GmbH

BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.


Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

June 18, 2014
BioGenes Launches 2-D DIGE Western Blot for HCP Detection and Quantification

Berlin, Germany, June 18, 2014 - BioGenes GmbH, a leader in host cell protein (HCP) assay development for biomanufacturing processes, announce the availability of a 2-D DIGE Western Blot service for highly accurate determination and electronic quantification of HCP coverage.

2-D DIGE Western Blot is a DIGE based fluorescent two-dimensional gel electrophoresis combined with a Western Blot that detects whole protein and HCP antibody signals on the same membrane. It allows the protein spots to be aligned perfectly with immuno-detected spots, thus eliminating any gelto- membrane variations. 2-D DIGE Western Blot uses two CyDye fluorescent dyes for labelling of total protein and HCP antibodies which enable signal detection at different wavelengths. CyDye fluorescence labelling is very sensitive and produces sharp and clear spots allowing an accurate and fully electronic analysis.

HCPs comprise the majority of protein contaminants derived from the manufacturing of therapeutic proteins and vaccines. HCPs are often immunogenic, can alter the therapeutic efficacy of a therapeutic drug substance and may affect patient safety. Therefore, the detection and quantification of HCPs is a major precondition for clinical trials of therapeutic proteins in human beings.

ELISA is a widely used technique to measure the residual HCPs and assess product purity. The current technique for estimating coverage of the HCP antibodies to the total HCPs present in a cell line is the comparison of a Coomassie Blue stained 2-D gel electrophoresis with an immunologically stained 2-D Western Blot. However, this technique may produce errors in pattern alignment between gel and membrane, is less sensitive than fluorescence and the results cannot be evaluated electronically.


About BioGenes GmbH
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.


Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
+49 (0)30 65762380