Latest News

Latest News

Quality management system according to the latest standards in software development

September 20, 2021
The worldwide increasing of standardization activities in laboratory routines also comes along with higher requirements for companies in the field of certification. Data analyses should be-come more comparable, of higher quality and reproducible. In order to meet these require-ments, Kapelan Bio-Imaging has been working on the implementation of a quality manage-ment system according to ISO 13485 (Medical Devices Directive) since the beginning of 2021. Although the previous processes were already valid, transparent, and predominantly met the requirements of ISO 13485, as a customer from the regulated market of pharmaceutical pro-duction also noted in the course of a supplier audit, the target markets are constantly demand-ing more evidence about processes and products and, thus, the quality of products. With the new QM system, Kapelan Bio-Imaging is therefore focusing on implementing and streamlin-ing its own processes and improving documentation with the aim of exploring new markets. The focus of the new digital QM system is on increasing the quality of the products from software development to testing and release to maintenance. A certification audit for the new QM system is planned by the end of the current year.

Interest in nature strengthened in pupils

July 30, 2021

Kapelan Bio-Imaging supports pharmaceutical companies and cooperation partners in many countries around the globe with software solutions for routine laboratory tasks. At the same time, however, the company and its employees are also dedicated to highlighting the im-portance of the environment and of ecosystems in the region. One way of doing this is to teach children as early as possible the vital importance of environmental protection and biodi-versity. Thus it was a pleasure for Kapelan to construct an insect hotel for the Lessing primary school in Leipzig. A few weeks later its interior was filled, together with the pupils, providing a home for bees and other insects in the near future. The insect hotel will give pupils from the school a first-hand opportunity to experience and learn about the life and work of bees on the school grounds. Kapelan CEO and hobby beekeeper Olaf Brenn explained the idea for the project: “It all start-ed when my daughter told me that they were being taught about the environment at school and especially about insects. In turn the subject of bees and honey came up, and as a hobby beekeeper this naturally caught my attention. That’s how the idea for the insect hotel came about.” After the construction of the basic framework by the Kapelan team, the insect hotel was filled and ‘opened’ together with the pupils from the Lessing primary school, who wel-comed the new city-centre insect habitat with great euphoria. Olaf Brenn and his team also took special delight in the presentation: “With the handing over of the insect hotel, Kapelan once again underlines how international activities and regional, voluntary commitment benefit-ting our children can – and should – go hand in hand.”

New innovative solution for EPO diagnostics

March 26, 2021

With LabImage 1D EPO, Kapelan Bio-Imaging presents a software solution specifically for routine EPO diagnostics. This approach is based on the established LabImage 1D platform combining the advantages of specific adaptability to individual laboratory processes with the possibilities of high-throughput image analysis.

This is made possible, on the one hand, by a maximum degree of automation, which enables automatic trace and band detection as well as quantification and reporting with only one software and, on the other hand, by configuration via macros, so that LabImage 1D EPO can be adapted to individual user needs at any time. This applies, for example, to the selection of molecular weight markers, the customizable background correction, the symmetry factor and the customizable report generation. In addition, LabImage 1D EPO is characterized by continuous further development and reliable support through full compatibility with all common operating systems while maintaining a high level of running stability.

With LabImage 1D EPO, Kapelan Bio-Imaging satisfies the highest demands in terms of customizability, automation capability and evaluation quality based on more than 20 years of experience in the field of imaging analysis. In addition to the routine use of LabImage 1D EPO, the software is also used in various other areas of application, such as in the pharmaceutical sector under the requirements of 21 CFR Part 11.

Quote WADA lab cologne: “We have been using the LabImage 1D EPO for quite some time for the evaluation of our samples in the daily routine. The adjustments we have made to the software with Kapelan significantly speed up the evaluation of the data and lead to valid and fast processes.”

 “Based on our own LabImage software environment, we are able to develop specific adaptations in data analysis efficiently and in compliance with standards. We see the application for the WADA laboratory in EPO diagnostics as a further step. We want to expand this position on the market.” explains Olaf Brenn, CEO of Kapelan Bio-Imaging from Leipzig/Germany.

New Netflix series Biohackers features LabImage 1D software

September 29, 2020

With its recent productions the pay TV provider Netflix is used to creating a stir, and its new highly topical series Biohackers, launched in the middle of the corona crisis, is no exception. The series revolves around a medical student who enrolls at a leading university on a secret mission to investigate a family tragedy connected with a professor of biology. Professor Lorenz teaches the synthetic biology course and the student, Mia, suspects that Lorenz has something to do with the death of her twin brother who died as a child.

The series includes scenes set in medical laboratories and in one of them Netflix uses the LabImage 1D software for data analysis. LabImage 1D can be seen in the background during a short sequence in series 1, episode 3.

“We were thrilled to have been approached by one of our sales partners with this request and were more than happy to assist in the shooting,” says Olaf Brenn, CEO of Kapelan Bio-Imaging.

Links

LabImage 1D https://v7.kapelanbio.com/products/apps/labimage-1d.html

Netflix Serie: https://www.netflix.com/de/title/81011660

 

New scanner available especially for part 11 compliant system

April 20, 2020

With the Epson Perfection V800/850, Kapelan integrates a new scanner into LabImage. The transmitted light scanner works up to 4 OD and delivers an outstanding price / performance ratio. Particularly in combination with a LabImage Part 11 system, it will sensibly expand Kapelan’s portfolio.
In parallel, the Microtek Bio-1000F will find its way into the list of supported devices. The compact scanner for all EtBr-alternative fluorescence stains can be placed on every laboratory table.
Both scanners are controlled via the new scan interface of LabImage and allow the creation of methods. All scan data is transmitted into the audit trail of a Part 11 compliant system.
Both scanners and the new scan interface will be available from the new release.

Start of implementation for own scanning user interface

February 5, 2020

We started to implement our own scanning user interface to provide an even closer integration of scanner and part 11 compliant analysis software. Doing this we able to control more scanners with better flexibility. We started with Epson V800/V850 scanner which is a valuable transmissive scanner with excellent scanning results and competitive pricing. Combined with the build-in LabImage calibration we can offer a perfect system for 1D gel analysis.

Kapelan receives an order to supply a 21 CFR Part 11 compliant system for 1D gel evaluation

October 16, 2019

After an intensive phase of test runs and validations, Kapelan receives an order to supply a 21 CFR Part 11 compliant system for 1D gel evaluation. The GMP-certified protein production / CMO customer has evaluated many aspects of the system and rated Kapelan positively in a customer audit. The focus of procurement was on the legal system, automatic processes of the 1D gel evaluation using methods as well as a valid device calibration. Based on network installation, the system will be able to perform 1D evaluations from multiple workstations.

The decision was deliberate for Kapelan after the customer carried out an intensive market assessment. In the end, LabImage 1D was the only system that made it possible to seamlessly integrate the device and provide clear documentation during the audit trail.

New research project to develop a HEART-ON-A-CHIP system for clinical and industrial applications – Kapelan awarded to develop software

June 4, 2019

– Heart disease is one of the leading causes of human death

– new research project to be developed a new chip system platform

– Kapelan Bio-Imaging wins contract for software development and device control

Heart disease is one of the most common causes of death for people around the world. In many cases, heart transplantation is the only way to preserve patient life. However, transplants can only help a few patients, as there will probably always be fewer donor organs compared to what is needed. The success of a transplant also depends on a successful suppression of the rejection reaction of the immune system. These treatment gaps cannot close stem cell based regenerative medicine for the foreseeable future.

The aim of technological development is a new test platform for miniaturized testing of heart muscle cells and their applications in drug screening and precision medicine. The test platform (process and device) will be developed based on the experience of partners from the Netherlands and using the digital-holographic supported quantitative phase-contrast microscopy as well as fluorescence imaging and impedance spectra.

Kapelan has been awarded for the development of a HEART-ON-A-CHIP system for clinical and industrial applications. Kapelan will take over the device controlling of the system and the data evaluation as software partner.

“The application of our software technologies to a new area, as in the case of chip systems and their data evaluation, is a new segment for Kapelan. We are very pleased to be able to contribute our expertise to this European consortium, “explains Olaf Brenn, CEO of Kapelan Bio-Imaging. The ZIM project is designed for 2.5 years and is supervised by the VDI / VDE.

21 CFR Part 11 Modules are extented with new release of LabImage

March 25, 2019

– Functional enhancements to the 21 CFR Part 11 module improve compliance
– Improved device management with methods
– Improvements to data storage in network environments

More and more, 21 CFR Part 11 compliant software solutions for 1D gels and Western blots are finding their way into routine applications. That was reason enough for Kapelan to launch GLP compliance in 2015 with the first LabImage Part 11 software. With the current release, new functions will find their way into the Part 11 catalog. Thus, the login to the user management has been extended, so that several users can register with a personal access.
Access to the LabImage 1D has been possible since the first version with personal access. For this purpose, settings for e.g. Password length and security and history are set.

Each action is also logged in the Audit Trail of the project. In addition to a search function for actions and an extended login in the audit trail, the management of devices and their calibration has also been improved. These innovations allow the creation of image generation methods and thus form e.g. with an imager or transmitted light scanner, a closed system in which the image never leaves the protected environment.

The exclusion of modifications and a full audit trail are the result that seamlessly documents the complete process of image data generation to evaluation. In combination with the fully automatic data evaluation via macros (methods), systems with an high level of automation are created. A valuable time saving to relieve employees of routine procedures.

The use of LabImage in workgroups and multi-user systems has improved with centralized data management. So it is possible that several users work in parallel on a central database. With the use of schemas in data management, self-contained data stores can be created to logically separate workgroups or topic areas.

In the future, in addition to the support of other commercial database systems, the significant expansion of the access right  system is planned, in order to be able to adapt the very large functional scope of the LabImage even better and more flexibly to the desired rights of users and groups.

New Trays for LabImager TR available

October 17, 2018

When LabImager TR was brought to the market it was mainly designed to use as strip reader. Now Kapelan provides more use cases. Using custom trays LabImager TR can be used as colony counter or micro plate reader. In combination with the right app from the LabImage Application Pool specific analysis system can be created.