Development, Qualification and Validation Services

GE Healthcare Bioprocess Services 

Whether it is upstream or downstream, scale-up or analytical development, GE Fast Trak process development services help improve the process performance from upstream, downstream, scale up and analytical development. Support capabilities include Cell culture and medium development, Clone screening, Conversion from stainless to single-use, Bioreactor process optimization, Resin screening and optimization, Design of experiments (DoE), High-throughput process development (HTPD), Process scale-up and proof of concept, Resin cleaning in place (CIP) studies & lifetime studies.  Fast Trak Bridge Manufacturing Services offer cGMP manufacturing support for faster market access. Support capabilities include cGMP BSL1, BSL2, document preparation, solution and buffer preparation, inspection, sampling, testing and release of materials, Quality assurance guidance and oversight, Bulk drug substance formulation, etc.

Thermofisher Scientific Gibco™ Bioproduction

Gibco® offers a wide array of innovative performance products and knowledge-based services, including fast and flexible cell line development, media and feeds, class-setting technologies, quality custom media development, and media optimizing services. Gibco bioproduction services have tools and solutions to help biotech and pharmaceutical companies during the upstream process development, from cell line through scale up. Custom Processing and Cleaning Services have the capability to clean plastic or glass containers and package them for customers. Learn More.

Merck Millipore BioReliance® End-to-End Services    

Millipore Process Validation & Equipment Qualification Services are configured to adapt to customer specific needs from development to production. BioReliance® End-to-End Solutions provide support and expertise customer needs from cell line to process development, clinical scale template, GMP clinical supply solutions, facilty design and construction, process scale up and technical transfer, and other biopharma expertise. Related resources include BioReliance® Biopharma Manufacturing & Testing Services, BioReliance® Gene Therapy & Viral Vaccine Contract Manufacturing & Testing, and BioReliance® Toxicology Services. In addition, BioReliance® Validation Services help customer select, test and validate the filters, assemblies and single-use systems,  with  Extractables and leachables testing, Bacteria retention testing, Integrity testing, Compatibility testing, Patient safety evaluations. Also see Video: Process Validation and Equipment Qualification Provantage® Lab Services for more services.

Wilco Calibration and Validation Services  

Wilco Validation Service offer supports throughout the entire design, production, testing, and post-delivery phases to ensure customer products meeting its pre-determined specifications and quality attributes. Calibration Service Wilco AG recommends to calibrating pressure sensors and flowmeters as well as measuring circuits in regular intervals. In addition, Customer Service Center  provides a large range of services, for examples, the on-site services include commissioning, production assistance, validation testing, training, support, servicing and repairs; the calibration services for all of the sensors and measuring loops are also available.

Mesa Labs Validation Services 

Mesa’s provide Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services. The complete Validation Services products include IQ/OQ/PQ Services & Documentation, Warehouse Mapping, Equipment Qualification & Calibration, Process Control Validation, Consulting & Assessment, SOP Development. The type of validation include Autoclave Validation, Depyrogenation Oven Validation, Lyophilizer Validation, Temperature Control Units Validation, Clean Room Validation, SureTorque ST-S3 Validation . In addition, Mesa Labs Cold Chain Management Services including Monitoring (Facility, Transport), packaging (Qualified Packaging, Rugged Coolers, Refrigerants, Components), and services such as Packaging Design & Qualification Services, Compliance Validation Services.

Capsugel® Biopharmaceuticals   

Capsugel® offers Technologies and Design, Development Services, Commercial Manufacturing, and Capsule/Encapsulation Technologies. Capsugel development services offer Preformulation and Formulation, Analytical Method Development, Stability and TestingRapid Advancement ToolsTechnology SelectionMultidisciplinary TeamsMicro-dosing ServicesClinical Trial Materials, and Clinical Supplies Solutions.

Biomerieux Industry Services and Performance Solutions

BioMérieux Biopharma Services have been designed to reinforce instrument services and develop professional- and performance-based services and solutions. A range of tailor-made services include EVISIGHT compact total vision, Endotoxin detection assays and services, culture media preparation and filling systems, enviromental monitoring, rapid mictobial detecting and sterility testing, blood bank/celluar products, microbial identification, non-sterile product testing, Bioball® quantitative strains and method validation, LABGURD 3D 24/7 automated enviromental monotiring system, customized manufactuirng, the pharma pathway, and validation package.

Sartorius Stedim Biotech Validation Service  

Sartorius Validation Service includes microbiological and physicochemical tests as well as extractables/ leachables. The Sartorius Validation Service complete process validation from implementing single-use systems to production process involves conventional equipment made of stainless steel, the service includes tests for process components such as: Filter elements, Disposable containers and bag systems for fluid management, Bags for freezing and thawing processes, Mixing systems, Disposable bioreactors, Transfer systems, Hose systems | connectors | seals, and Complex single-use systems and processes 

Pall Scientific and Laboratory Services 

Pall Validation Services include Process Specific Filter Validation, Filter Compatability Assessment, Bacterial Viability / Flush Testing, Bacterial or Bacteriophage Retention Studies, Microbiological Challenges with Process Isolates, Extractables Studies, Leachables / Migrants Analyses, Endotoxin and Particulate Testing. In addition, Pall Validation and Technical services provide validated single-use solutions for fluid handling and assisting in the implementation of Allegro single-use processing solutions from drug development to manufacturing operations. The Allegro single-use system validation program includes thorough documentation of test protocols and issuance of final reports that are ready to support regulatory submissions, general available validation services focusing on single-use system implementation include Allegro™ single-use extractables/leachable determination, compatibility testing, and sterilizing filter capsule validation.  Consultancy Services for Allegro™ Single-Use Systems provide customers with expert advice and support for the implementation of fully integrated single-use processing solutions into new or existing processes, including process optimization, equipment selection, pre-inspection process reviews, and troubleshooting advice.

NAMSA Testing Services

NAMSA offers all testing services in state-of-the-art laboratories using MRO® approach to the customer needs are met throughout the testing process. Technical Testing Services for validation include Packaging Validation, Method Development and Validation Services, and Sterilization Validation.

NeoPharm Labs

Neopharm offers consulting services for quality assurance and regulatory requirements to the pharmaceutical industry. Neopharm labs service products include chromatography and chemistry, microbiology and sterility testing, method development & validation services, stability services, quality assurance & consulting, and R&D analytical services.

Toxicon Pharma Product Development Services 

Toxicon preclinical pharmaceutical services includes: Pharmacology, PK/TK, Toxicology, Pathology Biodistribution, Reproductive Toxicology, Flow Cytometry, PCR, Immunology, ADME, Bioanalysis, Xenograft, etc.

3M Filter Validation for Pharmaceutical Production 

3M purification technical and scientific services provide validation services include but are not limited to: Integrity Testing in a specific fluid, bacterial retention studies, chemical compatibility studies, extractable testing and post-filtration filter autopsies. See more details from 3M purification technical and scientific services brochure.

PSC BioTech Services  

PSC biotech provides consulting, validation, and IT services. Related products include Validation, Compliance Management, Quality Systems, Documentation Protocol, Regulatory Affairs, Technical Management, IT Enterprise Systems for GxP Facilities, Laboratory Services, Training Programs, and GLP/GCP Services. Learn More about PSC BioTech Services Products.

Exova Pharmaceutical Testing  

Exova pharmaceutical testing services include Medical device testing, material sciences testing, trace metal services, pharmaceutical method development and research services, excipient, raw materials and container testing, extractables and leachables studies, CMC product development, and more.

AMRI Solutions

AMRI pharmaceutical services include Drug Discovery Solutions, Drug Development Solutions, Analytical Services, API Development and Manufacturing Solutions, and Drug Product Solutions.