The scalability of biotech processes is a key element in the successful and economic production of enzymes and other biotech products like carbohydrates or specialty chemicals. c-LEcta has scaled up and established processes for several biotech products based on two types of upstream processes: 1) fermentation with different microbial production hosts and 2) enzymatic biotransformations.
We operate a pilot-scale production facility for the routine production of some of our products as well as for the scale-up of processes to be transferred to external production sites. c-LEcta’s pilot-scale production facility and entire scale-up infrastructure enables process development using production equipment with identical working principles and with very similar process parameters compared to the available unit operations at our contract manufacturing partners in large scales. Thus, a direct single step process transfer from our internal pilot scale to external large industrial scale at our manufacturing partners is possible and is routinely and successfully applied.
Pilot plant capabilities
c-LEcta’s scale-up infrastructure consists of several controlled stirred tank vessels for fermentation processes with different volumes (mL, 1 L, 20 L, 100 L and 400 L). For all these scales appropriate downstream process equipment like separation devices, homogenizers, filtration modules, tangential flow filtration, chromatography systems or freeze-drying equipment is installed. One major advantage of our scale-up infrastructure is that industrial-scale process technologies can be downscaled to laboratory scale and process conditions can be implemented and optimized in parallel. Scalable processes are developed within a very short time and can be readily scaled up to first pilot scale (100 – 400 liters) and then into industrial scale (>10m3). Even in an early stage of process development, process parameters such as product yields derived from laboratory scale (e.g. 1 L) can be projected / extrapolated to industrial scale with high precision.
c-LEcta currently produces and supplies a broad portfolio of biotech products to the industry, most of which are enzymes used for various purposes. Besides our expertise in running biotech processes in large industrial scale, our competences also cover quality management, regulatory approvals, product registrations, professional distribution and logistics.
External production sites
Large-scale production is realized through partnerships with European contract manufacturing organizations (CMOs). To cover the demand of our customers for fast and reliable provision of our products in large quantities, we resort to established and tight partnerships with CMOs. All of our external partners have been qualified and are able to successfully execute our robust and sustainable production processes for a variety of industrial enzymes and other biotechnological products in an industrial scale (10 m3 to 100 m3 fermentation capacity including downstream processing equipment).
We mainly handle fermentation processes based on Escherichia coli, Pichia pastoris and Bacillus sp. Some of our products are produced and supplied as food-grade material to the industry and are manufactured according to HACCP principles. Our food enzymes comply with JECFA and FCC recommended specifications for food-grade enzymes. All our products are manufactured without the use of antibiotics or the use of materials from animal origin. One of our enzyme products is produced and supplied as GMP product complying with EU cGMP requirements for customers in the biopharmaceutical industry. In Leipzig, c-LEcta operates an ISO 9001 certified, quality-controlled, state-of-the-art facility with experienced technical staff to routinely produce, store and distribute our products.
Biological active products such as enzymes are sensitive to environmental conditions not only in process applications, but also during their storage. Therefore c-LEcta’s enzymes are in general developed with a special focus on robustness. Our customers moreover benefit from our experience in the application of a variety of stable formulations for enzyme products enabling a safe storage and shipment of our products all over the world.
Export logistics is completed by c-LEcta’s strong competence concerning the compliance with the respective national regulations. Up to now, c-LEcta has delivered its products to more than 250 destinations in more than 40 countries.