Our services

Our team of experts has a sound scientific background and keeps focused on regulatory and QA aspects, together with our managers, is growth and innovation oriented and works side by side with our customers in designing new processes or adapting existing ones.

Our experience in the fine-tuning of chemical and biological industrial processes for pharmaceutical and nutraceutical products allows us to meet our customers’ needs in the best possible manner.

We can support our partners through all the phases of the development of a new process.

FEASIBILITY	PROJECT and DEVELOPMENT PLAN	ANALYTIC DEVELOPMENT	VALIDATIONS
A specialised team will carry out a careful scientific assessment of each new project.	Our experts will prepare the development plan, identifying any possible critical points in the various process stages.	The methods will be studied, fine-tuned and validated according to the customer’s requirements and to the project.	All our development and validation activities are carried out in compliance with EU, JP, USP Pharmacopoeias and with ICH guidelines, and are implemented in the manufacturing processes.

To complete the project, a series of activities are implemented, from lab scale to the subsequent macrolab scale and to a pilot plant development stage, where necessary, the last stage being actual industrial production.

For the manufacturing of chemical products we have a series of multi-purpose facilities with capacities ranging between 3,000 and 12,000 litres, made of different materials (enamel or stainless steel) according to the type of raw materials and/or solvents used, as indicated below:

EQUIPMENT	UTILITIES
15 stainless steel reactors (Vol.: 8 x 6,000 litres – 7 x 10,000 litres) 9 glass lined reactors (Vol.: 1 x 3,000 litres – 2 X 6,000 litres – 5 x 8000 litres – 1 x 12,000  litres) 7 stainless steel centrifuges 3 coated centrifuges 4 dryers (Vol.: 1 x 1,500 litres – 1 x 3,500 litres – 2 x 4,500 litres) Electrodialysis unit (2 electrodialysis cells) 8 ionic exchange columns evaporators solvent recovery plants	Purified water unit (reverse osmosis) Chilled water unit Cooling water High Pressure Steam generator unit (18 bars) Liquid Nitrogen Storage Emergency power generator

Our Microbiology Unit has a new c/GMP-certified Pharmaceutical Laboratory authorized by the AIFA for the pharmaceutical manufacturing of Lactic Ferments, equipped with the following:

• 6 Fermenters with 20 litre capacity to study the operational parameters of processes
• 3 Fermenters with 130 litre capacity and 3 Fermenters with 200 litre capacity for the study and the technological development of processes
• 3 Fermenters with 2,000 litre capacity and 3 Fermenters with 4,000 litre capacity for the fine tuning of industrial processes for the production of active ingredients for the pharmaceutical and nutraceutical markets
• 1 Alfa Laval BTUX 510 Centrifuge and micro- and ultra-filtering systems for the separation of biomass.
  The equipment, tanks and pipelines which make up the plant are made of stainless steel and allow for steam sterilisation.
  The plant is operated by a distributed-control system characterised by a high degree of automation.
• 2 Freeze dryers with a loading capacity of about 300kg for the production of freeze-dried biomass
• 1 Rotary mixer with 500 litre capacity for the mixing of microbiological products, in bulk between them and with excipients.
• 2 Cold rooms for product storage at 2-8°C.
  The premises dedicated to freeze-drying and mixing are subject to temperature, dampness and overpressure control: personnel and materials enter via pass-through access.

In order to support the manufacturing and development of chemical and microbiological processes, Biosint in-house Quality Control Lab. ensures, in a timely and accurate manner, the performance of chemical and microbiological analysis, in way that every product, from raw material to finished product, (both API and probiotic bacteria), meet the highest quality standards in compliance with the approved specifications. Biosint Lab. is also able to perform environmental analysis, stabilities studies, and analytical methods validation.

Main equipment are as follows:

• Systems of High Performance Liquid Chromatography (HPLC-UPLC)
• Systems of Ionic Chromatography (IC)
• Systems of Gas chromatography (GC)
• Infrared (IR) Spectrophotometers
• Ultraviolet / Visible spectrophotometer
• Polarimeters
• Automatic titrators
• Karl Fisher titrators
• Laser granulometer
• Balances
• Thermal balances
• TOC analyzer
• Ph-meters

In particular, Biosint owns a Manufacturing Microbiological Lab. where the following activities are carried out:

• reisolation, characterization and preservation of probiotic strains (in particular probiotic bacteria);
• development of growth media and development of inocula;
• in-process controls.

ANCILLARY SERVICES

Regulatory activities
Support in the preparation of Dossiers in accordance with current national and international regulations.

Bulk packaging and shipping in compliance with international norms and GDP (Good Distribution Practices)
We ship all our products via a dedicated courier system, assuring that proper conservation temperatures are kept and products are continuously monitored. We cooperate with first-choice specialised suppliers to guarantee maximum delivery time flexibility.