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Passion for Performance
cGMP Biomanufacturing
Mammalian Cell Culture Upstream and Downstream ProcessingAseptic Filling
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In�our�cGMP�facilities,�which�are�operated�by�highly�skilled�and�well-trained�staff,�we�produce�biopharmaceuticals�for�clinical�studies�as�well�as�for�market�supply.�With�our�state-of-the-art�facilities,�we�are�able�to�meet�the�client�requirements�regarding�to�fl�exibility�and�highest�quality�standards�of�the�biopharmaceutical�industry.
We�offer�a�wide�variety�of�bioreactors�and�purifi�cation�equipment�for�mammalian�cell�culture�manufacturing�of�recombinant�proteins.�Our�full�service�solutions�are�complemented�by�aseptic�fi�lling�of�bio-pharmaceuticals�and�a�broad�range�of�project�supporting�analytics�for�quality�control.
Expertise•��Clinical�and�commercial�drug�substance�manufacturing•��Proven�track�record�of�more�than�320�bioreactor�runs•��Well-established�transfer�and�scale-up�processes•���Stainless�steel�bioreactors�up�to�3,000L�
including�2�x�3,000�L�Twin�•��Single-use�bioreactors�1,000�and�2,000�L•��Different�single-use�bioreactor�types�available•���Various�cell�separations�techniques�for�harvesting•���ATF10�for�perfusion�processes�up�to�1,000�L•���Production,�testing�and�storage�of�master�and�working�cell�banks
Cell Culture/Upstream Processing
Benefits•��Flexible�multi-purpose�cGMP�facilities•��Broad�variety�of�bioreactor�scales�and�technologies•��Cost-effi�cient�manufacturing•��Continuous�processing�up�to�3,000�L�scale•��Long-term�experience�with�diffi�cult�to�express�proteins
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Expertise•���Advanced�aseptic�fi�lling�technology�with�RABS�(restricted�access�
barrier�system)•��Single-use�and�stainless�steel�equipment•���Liquid�fi�lling�and�lyophilization�
�•��Vials�from�Din2R�to�50H�(fi�lling�volume�0.1�to�50�mL)•��15�m2�freeze�dryer�with�a�capacity�of�up�to�60,000�vials�(DIN2R)•��Volume�up�to�240�L�per�batch�
•��100�%�visual�inspection•���GMP�and�regulatory�compliance�according�to�EU�and�US-FDA�
regulations•��Fill�and�fi�nish�for�clinical�studies,�orphan�drugs�and�market�supply
Expertise•��Mobile�equipment�in�various�sizes•��Chromatographic�columns�up�to�80�cm�in�diameter•��Established�single-use�components•���Chromatographic�separation:�anion/cation�exchange,�affi�nity,�
hydrophobic�interaction,�size-exclusion,�reversed-phase•���Filtration:�microfi�ltration,�ultrafi�ltration,�diafi�ltration,�membrane�
adsorption•��Extraction:�aqueous�two�phase•��Viral�clearance�processes:�virus�inactivation�and�removal•��Protein�modifi�cation,�e.g.�PEGylation
Purification/Downstream Processing
Aseptic Filling
Benefits•��Wide�range�of�established�purifi�cation�methods•��Flexible�equipment�confi�gurations•��Full�single-use�processes•��Expertise�in�diffi�cult�to�purify�proteins•��High�quality�and�fastest�possible�time�to�market
Benefits•��Faster�product�launch�through�reliable�state-of-the-art�facility•���Drug�product�safety�through�advanced�technology�and�
standardized�processes•��Flexible�timelines�and�batch-sizing•��Process-oriented�structure�enabling�quick�decisions
Strategic Partnership with Rentschler Fill Solutions
One-stop solutions with state-of-the-art fill and finish facilities
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Benefits•��Ensuring�purity,�safety,�effi�cacy�and�stability�of�the�product•��Convenience�of�an�analytical�full-service•��Advanced�methods�and�cutting-edge�equipment•��Appropriate�and�custom-designed�solutions•��Stabilities�for�drug�substance�and�drug�product
Expertise•��Characterization�and�testing�of�biopharmaceuticals•��Generation�and�characterization�of�reference�material•��Qualifi�cation�and�validation�of�raw�and�packaging�materials•��Comprehensive�monitoring�of�all�product�quality�parameters•��Comparability�studies�for�process�changes�or�biosimilars•��Drug�substance�and�drug�product�release�testing
In-process and release assays (selection) •��Protein�quantifi�cation�•��Protein�sequencing,�amino�acid�analysis•���Chromatographic�methods�(size-exclusion,�reversed-phase,�ion�
exchange,�hydrophobic�interaction)•��Mass�spectrometry,�glycan�analysis•��Gel/capillary�electrophoresis•��Activity/potency�assays•���Process�related�impurities�(host�cell�protein,�protein�A,�insulin/
IGF,�DNA)•��Endotoxin,�bioburden,�sterility,�mycoplasma•��Compendial�methods
Stability Studies•��Active�ingredients,�intermediates�and�fi�nished�products•���Study�protocols�according�to�ICH�guideline�and�current�analytical�
specifi�cations•��Short�term,�long�term�and�accelerated�studies•��With�or�without�freeze/thaw�cycles
Quality Control
Rentschler Biopharma SEErwin-Rentschler-Str.�2188471�LaupheimGermanyTel:��+49�7392�701-0Fax:�+49�7392�[email protected]
Ren1067�03/10-2017 www.rentschler-biopharma.com
Rentschler Inc. 400�Oser�Ave.,�Suite�1650Hauppauge,�NY�11788�USATel:��+1�631�656�7137Fax:�+1�631�501�[email protected]
