cell culture in normoxia

6
3P Biopharmaceuticals 3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial. The Company offers an integral service for the process development and manufacture of biopharmaceutical products.

Upload: keatymore

Post on 11-Feb-2016

5 views

Category:

Documents


0 download

DESCRIPTION

3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial.The Company offers an integral service for the process development and manufacture of biopharmaceutical products.

TRANSCRIPT

Page 1: Cell Culture in Normoxia

3P Biopharmaceuticals

3P Biopharmaceuticals is a European-based Contract Development and Manufacturing Organization (CDMO) specialized in the process development and GMP manufacture of biopharmaceutical and cell therapy products from early stages (POC,PC) up to clinical and commercial. The Company offers an integral service for the process development and manufacture of biopharmaceutical products.

Page 2: Cell Culture in Normoxia

Biosynthesis Development

3P Biopharmaceuticals R&D Department supports development and optimization of processes offering batch, high cell density fed-batch fermentation, and perfusion, including medium and feeding strategy. By evaluating critical parameters of the process, such as related impurities control from the early beginning, the Process Validation team ensures successful scale-up and tech transfer.

Page 3: Cell Culture in Normoxia

Purification Development

3P Biopharmaceuticals supports the development of different biologics (innovative, bio-superiors and biosimilars) defining a robust, scalable, time and cost effective process in compliance with regulatory requirements.

R&D Department supports the development of purification, covering different steps of process, such as effective and well-controlled refolding, tangential flow filtration, chromatography media selection and optimization, virus inactivation, and filtration. By evaluating critical parameters of the process, such as related impurities control from the early beginning, the Process Validation team ensures successful scale-up and tech transfer.

Page 4: Cell Culture in Normoxia

Biologics

3P Biopharmaceuticals offers a highly integrated range of services to support the development and manufacture of biological products. Custom manufacturing of biologics from mammalian, yeast, and bacterial systems are developed from proof of concept to commercial stages being able to adapt to regulatory requirements for every phase (GMP certified).

Page 5: Cell Culture in Normoxia

Cellbanks

Generation and characterization of master/working cell banks 3P Biopharmaceuticals efforts have been focused on the installation of two separate rooms for the preparation of ISO5-classified cell banks with state-of-the-art biosafety cabinets based on the important development of the first phases of biologics.

Cell bank storage Cell bank storageAs a fundamental part of the chain of value of the products manufactured by 3P Biopharmaceuticals, storage of raw, intermediate and finished materials at 5 ° C, -20 ° C and -80 º C can be accommodated in control temperature in real-time.

Page 6: Cell Culture in Normoxia

Contact

Address : Polígono Mocholí C/ Mocholí 2 31110 Noáin Navarra – SPAIN

Phone : +34 948 34 64 80

Fax : +34 948 34 67 02

Email : [email protected]

Website : www.3pbio.com

Follow :