tecnogen eng

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About us Tecnogen is a world classbiotech development and

manufacturing organisation


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We are a ContractManufacturing Organisation

(CMO) focused on the

development and production

of monoclonal antibodies,

recombinant proteins and

extraction proteins, especially

for clinical trials.

We operate in full compliance

with current GMP and our

facilities are authorised by

Regulatory Authorities.

Tecnogens Production and

Quality Assurance activities aresupported by Development

groups with a wealth of

experience in production,

purification, processes and

methodology.

Our scientific expertise is

accompanied by expert

knowledge of biological

products development and,

importantly, international

regulatory requirements. We

can, therefore, support clients

from early discovery stages

up to clinical trial batchmanufacturing... and, potentially,

full scale manufacture depending

on the product.

Tecnogens strength lies in its

commitment to

continuous professional

training

constantly refining

know-how

sharing information

adherence to high ethical

standards

as its founding values.

Project Management capability

is a central element to our

work to deliver projects in a

timely manner.

Our work force flexibility

package allows a rapid and

efficient response to internal

and external requests.

Each member of our dedicated

team contributes his/her

personal skills to the

achievement of our collective

goals, recognising that ourtrue reward is not just in

commercial success but in our

contribution to the lives of

patients to whom our products

are addressed.

Founded in 1987 as a research

company, the transformation

to a specialised manufacturing

pharmaceutical company

started in 2000.

Tecnogen is part of the

Sigma-Tau Group and is

located in Caserta, Italy.

On December 22, 2010

Certyquality granted Tecnogen

the OHSAS 18001:2007

certification for the following

activities:

Development and production

of biotechnological injectable

drugs, prepared aseptically

in all experimental steps of

the clinical and pre-clinical

research via analytic and

biotechnological processes

on laboratory and pilot scale.


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to youOur commitment


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Our commitment to you is tobe a reliable partner dedicated

to achieving your goals.

The technical team and

management will work closely

with you to ensure that all

your deadlines can be met by:

A Quality Unit guarantees fullGMP compliance for

production, control and

documentation system, in

accordance with current

guidelines and regulatory

requirements.

Product release is performed

by our Qualified Person who is

involved fulltime in all

Tecnogen activities, starting

from the very beginning to

the end of the product

lifecycle.

As a result, Tecnogen provideshighly specialised process

development and cGMP

manufacturing services for

biopharmaceutical industry to

support pre-clinical and

clinical Phase I, II and III

trials and, potentially, full

scale manufacture.

Our facilities, equipment andutilities are designed to be in

regulatory compliance for

final marketed products.

Tecnogen can obtain the

appropriate production

regulatory authorisation in a

short time.

We offer a complete package

from cell line and assay

development, through process

development, GMP

manufacturing, aseptic filling

and GDP/GCP compliant

product shipping.

designing processes that fit your needs

or modelling your process prior to cGMP

manufacturing

implementing in-house or client

processes and appropriate control steps

producing according to your needs and

timing

validating appropriate processes andmethods

evaluating data and process effectiveness

and robustness

adapting to customer requirements

collecting CMC data in a format ready

for IMPD preparation

The predisposition to a complete

procedure: from the development of the

cell line and test, to the schedule of

processes and production according to

cGMP, up to aseptic filling and products

shipment according to GDP/GCP


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Monoclonal antibodies andrecombinant proteins productionand purification processdevelopment and validation

Formulation development

Analytical development

cGMP Clinical Manufacturing ofmonoclonal antibodies and

recombinant proteins for allclinical phases

Preclinical manufacturing

Scale up manufacturing process

Aseptic filling

GDP/GCP shipment

Biochemical and chemical testing

Microbiological testing

Methods validation

Stability studies

Our capabilities include:


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Meeting patient and client needs throughinnovative processes and talented people


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Development

A thorough scientific

evaluation is performed for

every incoming project

before issuing a customprogram identifying clear

milestones and deliverables.


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Quality of processes developedis monitored through a variety

of biological, biochemical and

biophysical methods.

The program can involve some

or all of the following expertise.

Process Development

Upstream Process

Development

Mammalian cell lines

transformation and protein

expression in transient andstable conditions

Cloning and

characterisation

of hybridomas

Development and

optimisation of

fermentation processes

(batch, fed-batch,

perfusion, disposable

technology)

Production of recombinant

proteins and antibodies

Downstream ProcessDevelopment

Development of

recombinant proteins

purification processes

Development of

monoclonal antibodies

purification platform or

specific process

Extraction of natural

proteins

Protein characterization:SEC-HPLC, ELISA, SDS-

PAGE, native PAGE, IEF,

2D, Western blotting, LC-

MS, peptide mapping,

isothermal titration

calorimetry (ITC),

Fluorescence spectroscopy,

Circular Dichroism (CD),

host cell protein analysis

(HCP), Residual DNA

quantification by

Threshold System

Proteins modification

(biotinylation, PEGylation,alkylation, oxidation)

Production ofdevelopment batches of

high purity grade

Formulation

Development

Studies on different

formulations can be performed

including stability tests.

Analytical

Development

Qualitative and quantitative

methods can be developedaccording to customer

requirements.


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Production


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Pre-clinicalManufacturing

Batches for pre-clinical studies

and reference material can be

prepared.

Adequate sample amounts

can be supplied for validation

purposes (e.g. viral

inactivation/removal studies,

sterile filtration). An accurate

documentation of the

preparation is made available

for each sample to support its

validity for its intended use.

cGMP Clinical

Manufacturing

Activities are focused on

producing monoclonal

antibodies/recombinant

proteins from cell culture and

proteins purification according

to appropriate regulatory

standards in order to support

clinical trials (Phase I,II,III).

Tecnogen recognises theimportance of a fully

integrated QA/QC function

and has successfully

established a quality-oriented

approach to all aspects of the

manufacturing process. We

rely on disposable material in

many steps of production.

We can offer:

upstream processing/cell

cultures

downstream

processing/protein

purificationfill and finish technology

Upstream Manufacturing

The Area is equipped with

25L, 100L, 500L working

volume bioreactors that allow

the cultivation of hybridoma

and other mammalian cells to

obtain biopharmaceuticals

such as antibodies and

recombinant proteins.The bioreactors allow the

cultivation of cells in perfusion/

batch/fed-batch mode. They

are equipped with automated

devices controlled by a

SCADA Supervisory System

with two operator

workstations able to start any

operation in automatic mode.

All the parameters, during cell

growth, are continuously

adjusted and recorded.

Master and Working Cell

Banks can be prepared.


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DownstreamManufacturing

The Area is equipped to

support purification and

formulation of proteins using

a wide range of

chromatographic techniques

(e.g. Affinity, Ion Exchange,

Hydrophobic Interaction),

viral inactivation/removal and

Tangential Flow Filtration.

The downstream area is

designed with separated

suites for virus+, virus-, buffer

preparation, storage, andwashing.

Our purification facility can

support quantities from grams

up to a kilogram per year.

Fill and FinishManufacturing

The Area is equipped for

aseptic filling, with automatic

filling and crimping machines,

both located in grade A

environment with grade B

background. There is an

alarmed system for

continuous particle and

microbiological monitoring.

Aseptic processes are

validated by performing

media fills.

A volume of bulk product aslow as few hundreds millilitres

can be handled. Filled vials are

visually inspected; the vials are

then labelled with an

automatic labelling machine.

GDP/GCP CompliantShipment

Shipment of clinical trial

products is performed with

dedicated transport at

appropriate storage

temperature and continuous

monitoring. Short delivery

times and great operational

flexibility are achieved in

cooperation with specialised

and qualified suppliers.


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Analytical tests on raw

materials, active ingredients,

intermediates, packaging

materials and finished

products are performed in

GMP laboratories, according

to relevant Pharmacopoeias.

Tests include a wide range of

biochemical analyses forrecombinant proteins and

monoclonal antibodies.

The following internal and

external services are

available.

BiochemicaI and Chemical

Testing

SEC-HPLC, SDS-PAGE (under

reducing and non-reducing

conditions), IEF, Western

Blotting, ELISA, protein

concentration, biotinylation

level, residual Host CellProtein quantification.

HPLC, UV/VIS

spectrophotometry, pH,

conductivity, TOC, osmolality,

loss on drying, heavy metals,

potentiometric titrations,

nitrogen content

determination by Kjeldahl

method. Determination of

visible and sub-visible

particles.

Microbiological Testing

Microbial counts (bacteria

and fungi), bacterial

identification, bacterial

endotoxins, sterility test.

Methods Validation

Analytical methods are

validated according to the

development stage of the

product. Validation can

include: accuracy, precision

(repeatability, intermediate

precision, reproducibility),

specificity, limit of detection,

limit of quantification,

linearity, range, robustness.

Stability Studies

Stability studies are performed

according to ICH guidelines inlong term and accelerated

storage conditions.

Qualitycontrol


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Production Area

Production Area

QC Lab

Development

Technical AreaWarehouse


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Design:Fabio

Finocchioli


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TECNOGEN SpA

Registered Office - Administration

Laboratories - Production:

Location La Fagianeria

81013 Piana di Monte Verna (CE) - Italy

Tel. +39 0823 612 301

Fax +39 0823 612 555

www.tecnogen.it

tecnogen eng

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