Latest News

Ready for the new requirements for joint food enzyme dossiers?

Ready for the new requirements for joint food enzyme dossiers?

EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in planning, testing, and documenting the safety of your food enzymes.

Joint dossiers have led to several challenges and data gaps in submitted documentation, which is the background for EFSA requiring that enzyme applicants now send a company specific full data package. Additionally, these requirements will also require a full toxicological package conducted in accordance with current regulatory guidelines.

For years it has been possible for food enzyme producers to group their individual food enzymes under one umbrella application, provided that these enzymes have the same catalytic activities, are manufactured substantially by the same process, and originate from the same organism. However, due to confidentiality issues, this procedure has led to a lack of specific information on e.g. the production strain and the chemical composition of each food enzyme.

Check out EFSA’s presentation about these changes here. EFSA also has a presentation of their AMFEP meeting here.

SAXOCON can help you quickly prepare for these regulative changes, find out more about how we can help here.


SAXOCON Webinar on ISO 10993-17

SAXOCON Webinar on ISO 10993-17

Today we held our first webinar via YouTube Live. Carsten B. Senholt, our Principal Toxicologist and CTO, discussed the breaking news about the newly released ISO/CD 10993-17. So, if you want to get up to speed on the newest requirements regarding toxicoligy risk assessment of medical device constituents the check out the webinar here.


The 1st Extractables and Leachables Network Meeting

The 1st Extractables and Leachables Network Meeting

SAXOCON A/S was proud to have hosted the first Extractables and Leachables (E&L) network meeting and we are looking forward participating in this exciting and important network going forward.

The E&L network is conceived to support competence building and knowledge sharing among Danish pharmaceutical companies.


We’ve Moved

We’ve Moved

After a 2019 of rapid growth SAXOCON has now moved to new, bigger offices.

Our new headquarters is now located at:

Bredevej 2D
2830 Virum


SAXOCON is a Gazelle!

SAXOCON is a Gazelle!

2019 has been quite a year for us here at SAXOCON. In July we became SAXOCON A/S and today we can proudly announce that we are a GAZELLE 2019.

This has only been possible thanks to our loyal customers and our skilled and dedicated SAXOCON employees. We take great pride in delivering high-quality and timely services that make a difference, ensuring that products produced and sold around the world are biologically safe.

Thanks!


SAXOCON A/S

SAXOCON A/S

Today, 1 July 2019, is a great day to be a SAXOCON’er 🙂

We have reached an important milestone and are so proud to announce our new status as SAXOCON A/S.


DTU IP Pitch 2016

DTU IP Pitch 2016

SAXOCON was invited to DTU IP Pitch as an example of a “company success story”.

See SAXOCON CEO Martin Friis-Mikkelsen’s presentation here.


SAXOCON i Dynamo – nyhedsmagasin fra DTU

SAXOCON i Dynamo – nyhedsmagasin fra DTU

Fra Dynamo 49 | 09 | 16:

Spinout-virksomhed
fra DTU Fødevareinstituttet:

Bedre arbejdsmiljø og medicinsk udstyr

Vi efterspørger i stigende grad produkter med avancerede egenskaber. Det giver industrien udfordringer i forbindelse med udvikling af metoder, arbejdsgange og ingredienser, der også tilgodeser behovet for sikkerhed.

Det mærker rådgivningsvirksomheden Saxocon, der er ekspert i at hjælpe industrien med analyse af kemiske stoffer.

”Vi får henvendelser fra mange forskellige parter i industrien, og databasen er blevet et vigtigt redskab til at understøtte vores ekspertvurderinger,” fortæller Martin Friis-Mikkelsen, direktør i Saxocon.

Det kan være introduktion af nye kemiske stoffer i arbejdsprocessen eller ingredienser i det færdige produkt, der giver anledning til usikkerhed. ”Med en QSAR-analyse kan vi hurtigt give kunderne et godt grundlag for at beslutte, om de skal droppe introduktionen af et kemisk stof, eller om der f.eks. er behov for yderligere tests, inden de går videre. Det sparer ressourcer hos virksomhederne og gør det meget lettere f.eks. at forbedre arbejdsmiljøet eller udvikle sikre produkter,” forklarer Martin Friis-Mikkelsen.

Han ser et stort potentiale i den nye database.

”Bare inden for produktion af medicinsk udstyr er behovet enormt. Hvordan sikrer vi f.eks., at børn på neonatalafdelingerne kommer i kontakt med så få skadelige stoffer som muligt fra slanger og andet apparatur? Her er QSAR et helt fantastisk redskab,” siger Martin Friis-Mikkelsen.


Pris til QSAR-teamet på DTU

Pris til QSAR-teamet på DTU

Pris for at forudsige kemiske stoffers skadelige effekter uden forsøgsdyr

Computermodeller udviklet på DTU Fødevareinstituttet kan forudsige en lang række af de skadelige effekter, forskellige kemiske stoffer kan forårsage. Det har ført til øget viden, der kan bruges til at prioritere og vurdere tusinder af kemiske stoffers sikkerhed verden over uden brug af forsøgsdyr. For arbejdet med at udvikle modellerne har forskere på instituttet modtaget en pris fra Danmarks 3R-Center. Centeret har som formål at finde alternativer til dyreforsøg.

Se artiklen her


Attend  the SAXOCON Seminar on May 31st, 2016

Attend the SAXOCON Seminar on May 31st, 2016

Kravene til medicinsk udstyr er stigende. Har du styr på ISO 10993? Har du styr på, om de materialer, som du anvender i dit produkt er sikre? Følger du den del af guidelinen, som omhandler reduktion af dyreforsøg i forbindelse med den biologiske sikkerhedsvurdering?