Capability
Aseptic Processing CDMOs
Compare CDMOs with validated aseptic processing capabilities. Filter by isolation technology, cleanroom classification, and sterility assurance approach.
50 companies listed
About Aseptic Processing
Aseptic processing is the manufacturing of sterile drug products without terminal sterilization. The product is sterilized by filtration (0.22 micron) and filled into pre-sterilized containers in classified clean environments. This technique is essential for biologics, proteins, and other heat-sensitive products that cannot withstand autoclaving.
The sterility assurance strategy defines CDMO capability. Modern approaches use isolator technology (closed systems with HEPA-filtered air, vaporized hydrogen peroxide decontamination) for the highest contamination control. Older approaches use RABS (Restricted Access Barrier Systems) or conventional cleanrooms. FDA and EMA increasingly favor isolator-based systems for new facilities.
Companies (50)
C
CellPharma AG
Switzerland
CellPharma AG is a leading contract development and manufacturing organization headquartered in Switzerland. We specialize in Cell & Gene Therapy, Formulation Development, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
G
GlobalPharma AG
Italy
GlobalPharma AG is a leading contract development and manufacturing organization headquartered in Italy. We specialize in Small Molecule API Manufacturer, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Lonza
China
Lonza is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Revatis
Belgium
Revatis is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
H
Himachal Polyolefins Ltd
India
Himachal Polyolefins Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
ChemCon GmbH
Germany
ChemCon GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Eskay Iodine Pvt Ltd
India
Eskay Iodine Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
GC Cell
South Korea
GC Cell is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Recipharm (Rechon Life Science AB)
Sweden
Recipharm (Rechon Life Science AB) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Elementis Pharma GmbH
Germany
Elementis Pharma GmbH is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
AM Instruments
Italy
AM Instruments is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
ABFEN FARMA
Turkey
ABFEN FARMA is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Emergent BioSolutions
Canada
Emergent BioSolutions is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
C
Coriolis Pharma Research GmbH
Germany
Coriolis Pharma Research GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
G
Grace Davison Chemicals (India) Pvt Ltd
India
Grace Davison Chemicals (India) Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Synbias Pharma AG (Synbias–Gemini Group)
Germany
Synbias Pharma AG (Synbias–Gemini Group) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Fraunhofer-Gesellschaft
Germany
Fraunhofer-Gesellschaft is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Nanomol Technologies S.A.
Spain
Nanomol Technologies S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Integer Holdings Corporation
China
Integer Holdings Corporation is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Fabtech Technologies Limited
India
Fabtech Technologies Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Exemed Pharmaceuticals
India
Exemed Pharmaceuticals is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
BioFusion JSC
Poland
BioFusion JSC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Altruist Biologics
China
Altruist Biologics is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
C
Chemoforma AG
Switzerland
Chemoforma AG is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Loxim Industries Limited
India
Loxim Industries Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
G
GenePharma B.V.
France
GenePharma B.V. is a leading contract development and manufacturing organization headquartered in France. We specialize in Small Molecule API Manufacturer, Clinical Trial Materials with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
I
ITECO Engineering
Italy
ITECO Engineering is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
A
AdvancedPharma GmbH
Spain
AdvancedPharma GmbH is a leading contract development and manufacturing organization headquartered in Spain. We specialize in Small Molecule API Manufacturer, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Peter Greven Nederland C.V.
Netherlands
Peter Greven Nederland C.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Gennex Laboratories Limited
India
Gennex Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Fabtech Technologies International Ltd.
India
Fabtech Technologies International Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
YCP Consus / Consus Global
Indonesia
YCP Consus / Consus Global is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
A
Aptuit LLC
Italy
Aptuit LLC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Oleochemicals India Pvt. Ltd.
India
Oleochemicals India Pvt. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
C
Chengdu Pukang Biotechnology Co., Ltd.
China
Chengdu Pukang Biotechnology Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Softgel Healthcare Pvt Ltd
India
Softgel Healthcare Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
SKYEPHARMA (Skyepharma Productions SAS)
France
SKYEPHARMA (Skyepharma Productions SAS) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Berlin‑Chemie (Menarini Group)
Germany
Berlin‑Chemie (Menarini Group) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Morepen Laboratories Limited
India
Morepen Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
ITW Reagents (PanReac AppliChem)
Germany
ITW Reagents (PanReac AppliChem) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Pharmchem
United States
Pharmchem is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
FREZYDERM S.A.
Greece
FREZYDERM S.A. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Medisky Pharmaceuticals Pvt Ltd
India
Medisky Pharmaceuticals Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
PENMIX Co. Ltd.
South Korea
PENMIX Co. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
M
Mytos Bio Ltd
United Kingdom
Mytos Bio Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Normon
Spain
Normon is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
G
Grace Fine Chemical Manufacturing Services
China
Grace Fine Chemical Manufacturing Services is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
C
Canaan Technology Group (Zhejiang Canaan Technology Co., Ltd.)
China
Canaan Technology Group (Zhejiang Canaan Technology Co., Ltd.) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Salinen Austria AG
Austria
Salinen Austria AG is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Edelmann GmbH
Brazil
Edelmann GmbH is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Frequently Asked Questions
What is the difference between isolators and RABS?+
Isolators are completely sealed enclosures with HEPA-filtered air supply and H2O2 decontamination between batches. Personnel never enter the isolator environment. RABS (Restricted Access Barrier Systems) use physical barriers but share air with the surrounding cleanroom and allow limited interventions through glove ports or open doors (active vs passive RABS). Isolators provide superior sterility assurance but require longer setup times and higher capital investment.
How do CDMOs validate their aseptic process?+
Aseptic process validation requires: media fill (process simulation) studies where sterile growth medium is filled in place of product, with the goal of zero contaminated units. FDA requires a minimum of three consecutive successful media fills. Environmental monitoring data, personnel qualification (gowning, aseptic technique), and equipment qualification are also required components of the validation package.
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