Services

TECNIC’s biotechnological department is dedicated to support customers with their biological
processes. A proper Tech Transfer is the first step for a proper scale-up, followed by an
equipment characterization.


TECNIC is also really focused on continuous product improvement; eLAB and ePILOT
bioreactors and tangential flow filtration equipment are continuously tested at our BSL2
microbial and cell culture laboratories. processes to the production phase.

Scale-Up

TECNIC adapts its equipment to customer’s needs based on their processes seeking a higher productivity.

eSCADA

Supervising Control And Data Acquisition Software

* CFR21 Part 11 do not allow modifications in recipes while running

Technology Transfer

We advise and accompany our customers in the transfer of technology to GMP certified production plants, to their own plants or to third-party plants (CMOs). Technology transfer is a crucial point, as it requires the transfer of scientific and technological knowledge from the client to the company to obtain an efficient, orderly and systematic scalability. Documentation and reproducibility is the mainstay of technology transfer.

Bioprocess Scale-up

We accompany and advise our customers from the initial stages of product design, through scalability, from production processes to the production phase. TECNIC has the capacity to adapt upstream equipment (innovative process engineering), seeking in each step the greatest efficiency and innovation. The upstream process consists of scaling the in vitro culture to bioreactors of 5L, 30L and up to 100L. For the manufacture of these bioreactors, different materials are used (stainless steel, borosilicate glass, etc,); magnetic agitation and digital instrumentation are chosen considering pH and ORP, pO2, conductivity, VCD, TCD, CO2 and foam levels; and the utmost attention is paid to the aeration system required and to any other parameter that may affect the culture. TECNIC uses the latest technology both for benchtop equipment and for production and preparation for GMP. Different retention systems and modes of bioreactor operation (batch, continuous, fed-batch or perfusion) are also tested.

Bioprocess Scale-Down

Once the upstream process has been optimized for each of the scaling bioreactors, the downstream process will proceed to purify the product. The purification process increases sophistication in accordance with the biosafety requirements of the product.

Facilities

From Laboratory to Production Scale

Laboratory

Pilot plant

Turnkey Projects

Process design and execution

Conceptual design
Basic engineering
Detailed engineering
Process equipment assessment and selection
Project execution