Research For better living

category: News item

Successful submission of all dossiers before REACH deadline

We proudly announce that the Registration Services & Risk Assessment team of Triskelion enabled all of their REACH clients to comply with the 3 major legal deadlines in 2010, 2013 and 2018.

Years of helping clients with their registration strategies, data gap analyses, SIEF discussions, pushing for early action, outsourcing and monitoring studies, creating IUCLID files, preparing read-across justifications and exposure assessments paid off as we were able to send the final files and dossiers to the clients well before the final deadline of 31 May 2018.

By focusing on being proactive, applying strong project management techniques and putting our experience collected through years of service into practice, unpleasant surprises were kept to a minimum.

For substances with ongoing studies we ensured eligibility for the Directors Contact Group solutions. Our structured approaches and familiarity with relevant tools ensured that we could finalize quality dossiers in time.

All in all, thanks to good preparation and experience we were able to make our clients happy, delivering a few hundred high-quality REACH dossiers ranging from relatively simple dossiers  to very large dossiers with lots of data or extensive use of read-across and other alternative approaches. Simultaneously with these activities, we were also meeting the needs of our clients in the scope of the Biocidal Products Regulation.

And, of course, the REACH-related activities continue: dossiers have to be updated and resubmitted, the communication with ECHA on (draft) decisions and approval of test proposals continues, downstream user communication is getting more attention and clients need support in the scope of restriction or authorization processes.

We look back on fruitful and successful cooperation with our clients before the REACH deadline and we look forward to continuing our support for the chemical industry with our regulatory services in the future.

Triskelion’s transition plans and altered services portfolio as of January 1, 2019

Taken into consideration the current technical developments on pharma, food and chemical testing in combination with the Dutch and EU governmental desire to reduce animal use in testing, Triskelion has decided to redirect its focus on analytical and registration services. We will therefore discontinue our GLP and animal related services as of January 1, 2019. We will finish the ongoing projects in accordance with the quality standards as promised, and GLP related services will remain in place until the final transition has been completed.

We would like to emphasize that our decision does not affect the animal related research activities of TNO (www.tno.nl), the organization from which Triskelion originates.

The following services will no longer be offered as of January 1, 2019:

Toxicology (in vivo and in vitro)
Immunology (in vivo and in vitro)
Histology
Pathology
ADME/DMPK (in vivo and in vitro)
GLP services

We will focus on delivering best in class solutions in the area of:

Nutrient analyses
Genetically modified Organisms (GMO) analyses
Authenticity analyses
Emergency Response Service (ERS)
Registration Services & Risk Assessment
Packaging (migration, petitioning and compliance)
TIM: gastrointestinal models (services & lease)
Analytical services: method development & validation and sample analyses

Triskelion takes pride in being your trusted partner in these fields of expertise. We will ensure to deliver the altered services portfolio to the highest standards applicable. During the coming months we will inform you about the next steps we will take in building our altered services portfolio. Please check our website for available updates.

Might you have any questions, please feel free to contact us: info@triskelion.nl.

New FAO recommendation of protein quality measurement DIAAS

To meet the protein requirements of its growing population, the world must discover new alternative protein sources. It is therefore essential to understand the value and consequent suitability of these proteins for human nutrition.

The FAO recommends the use of the Digestible Indispensable Amino Acid Score (DIAAS) method instead of the PDCAAS measurement. The DIAAS is based on the true ileal digestibility of each amino acid preferably measured in humans or animal models. The Three Rs (3Rs) principle, the guiding principle for more ethical use of animal testing, is one of the corporate responsibilities of the food industry. So are you ready for DIAAS without expensive clinical or animal trials?

Triskelion has developed an in vitro method which allows rapid and cost-effective evaluation of both, the true ileal digestibility and the DIAAS method. Our unique dynamic in vitro gastrointestinal model tiny-TIM simulates the dynamic conditions of the upper tract. DIAAS can be accurately and reliably determined in the TIM system (Havenaar et al 2016). The dynamic gastrointestinal TIM models are a validated alternative for animal testing.

If you are interested in speeding up your product development process, please contact us: info@triskelion.nl.
We would be more than happy to give you more information.

OrBiTo webinar 16 April 2018 at 4 pm (CET)

We’re happy to announce the open OrBiTo webinar that will take place on Monday 16 April 2018 at 4 pm (Central European Time).

The webinar will kick off with a brief introduction of the OrBiTo project explaining the work packages, the organization and the obtained results (Dr. Bertil Abrahamsson – AstraZeneca). The second speaker (Philipp Jedamzik – University of Greifswald) will inform you about the biorelevant dissolution model ‘GastroDuo’. A final talk will be given by Dr. Ronald Schilderink (Triskelion) and Dr. Richard Barker (AstraZeneca). Both will present their latest findings related to the TIM advanced gastric model.

This will be an open webinar so feel free to inform your colleagues and let them attend our annual webinar!

For TC information, please click here.
Enter the Meeting ID: 507822439 or use the pairing code.
Enter the Passcode: 2130.

More information can be found on LinkedIn.

For any questions, please feel free to contact us: info@triskelion.nl.

The future of LC-MS?

Triskelion proudly presents an interview with expert Anne Kleinnijenhuis, which was filmed at the EBF conference. Please click here to see the interview, posted by Bioanalysis Zone.

In this interview, Anne Kleinnijenhuis describes his current research focus, and what first began his interest in LC–MS. Anne goes on to discuss the challenges involved in the techniques he uses, and specifically identifies the key challenges he faces when utilizing LC–MS. Anne concludes by discussing regulating and standardizing LC–MS before speculating on the future of the technology.

Please do not hesitate to contact us in case you have questions or remarks: +31 6 5280 3578 / pharma@triskelion.nl.
We would be happy to provide you with more information.