Projects

Our product developments are driven forward within the framework of interdisciplinary projects. At the beginning there is always a vision to make something better, healthier or more sustainable with the help of our products. 

Our development pipeline is filled with numerous ideas that we evaluate until the best product is ready to hit the market.

Development pipeline

Overview_Projects-lifecycle

Development of DENARASE

2009 - 2012

Start of DENARASE project: Strain selection, development of upstream and purification process

Project started: Application of en­do­nu­clea­ses for DNA removal during protein purification

c-LEcta‘s Bacillus strain, an endotoxin-free expression host, yielded highly active DENARASE product. Purity of ≥99 % was achieved after purification.

Fermenter_1000x1000

2012

Manufacturing of DENARASE under GMP conditions

Requirements of the biopharmaceutical industry for a GMP product were identified

Partnering with a contract manufacturing organization (CMO) to produce DENARASE under EU GMP conditions

Manufacturing process free of animal derived raw materials and antibiotics was established

Production_1000x1000

2012

Product launch of DENARASE

DENARASE fulfills highest quality standards for biopharmaceutical manufacturing

Starting to build a global sales and distribution network for life science customers

Growth of internal quality, production, distribution and sales functions

DENARASE_1000x1000

2017

First DENARASE-related patents granted

Patents were successfully granted for the production technology of DENARASE based on recombinant expression in Bacillus

DENARASE-Patent-USA

2020

Launch of DENARASE ELISA Kit

Launch of own ELISA kit for the detection of S. marcescens endonucleases in process-derived samples

Fastest and most sensitive ELISA kit available on the market

ELISA-Kit_1000x1000

2020

COVID-Support

Focused support for customers developing and manufacturing COVID-19 vaccines at unprecedented speed

Concerted efforts of c-LEcta teams with COVID-19 vaccine customers succeeded in the delivery of large, unplanned quantities of DENARASE on short timelines

c-LEcta’s resilient manufacturing and distribution network kept COVID-19 related supply issues to general customers at an absolute minimum

c-LEcta-covid-vaccine

2021

Drug Master File for DENARASE accepted by FDA

Dedicated regulatory support for US-market approvals of pharmaceutical products via own US FDA Drug Master File.

In addition, certified compliance with the EXCiPACT and ANSI NSF 363 Standard (meeting GMP for pharmaceutical excipients)

EXCIPACT-Collage

2022

Global application of DE­NA­RASE and ELISA kit in biopharma­ceutical manufacturing

DENARASE and ELISA kit are established highest-quality products, applied in the manufacturing of viral vectors for Gene therapies and vaccines:
> 150 customers in > 30 countries

DENARASE is applied in 4 Commercial and 40+ Clinical Phase I-III viral vector manufacturing processes

AdobeStock_335262300_Preview

2023

New sizes of R&D-grade DENARASE available

c-LEcta has just launched additional sizes of DENARASE for research and development use.

Being widely applied in biopharmaceutical R&D and manufacturing, DENARASE sizes of 1 MU and 5 MU will now also be available as R&D-grade, in addition to GMP-grade.



DENARASE_R&D_1
Generated with Avocode.Pfad 1179 Generated with Avocode.Pfad 1179

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