Exelead Biopharma a MilliporeSigma company

Exelead Biopharma a MilliporeSigma company
Exelead Biopharma a MilliporeSigma company

Description

Exelead Biopharma, a MilliporeSigma company, specialises in lipid-based and pegylation manufacturing services, providing comprehensive contract manufacturing and development solutions to biotechnology and pharmaceutical companies. As a Contract Manufacturing Organisation (CMO) and Contract Development and Manufacturing Organisation (CDMO), Exelead delivers end-to-end services that encompass a wide range of pharmaceutical needs, including finished dosage formulation and cell and gene therapy.

Services include:
- Regulatory Services
- Protein and Peptide
- Injectables
- Clinical Dose
- Packaging
- Clinical Packaging
- Analytical Services
- 505(b)(2)
- Accelerated Stability Studies
- Agglomeration
- Anti-Counterfeiting Technology
- Aseptic Fill/Finish
- Assay Development
- Bioanalytical Services
- Biological Testing
- Biologics
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- Biostatistics
- Calibration
- cGMP Synthesis
- Chemical Analysis
- Chromatography
- CIP Process Systems
- Clean in Place / Sterilization in Place (CIP/SIP)
- Clean Room Services
- Clinical Analysis
- Clinical Monitoring
- Clinical Trials
- Chemistry (CMC)
- Manufacturing
- Cold Chain Management
- Commissioning
- Consulting
- Records Management
- Six Sigma
- Contaminant Analysis
- Contract Development and Manufacturing (CDMO)
- Contract Manufacturing (CMO)
- Contract Packaging
- Contract Research (CRO)
- Sourcing
- Custom Synthesis
- Distribution
- Documentation Support Services
- Downstream Processing
- Drug Delivery Devices
- Drug Development
- Electronic Data Management
- Endotoxin Testing & Removal
- Engineering and Design Services
- Enterprise Resource Planning
- Environmental Analysis
- Environmental Monitoring
- Testing
- Facility Design & Construction
- Facility Management Services
- Filling
- Syringe
- Vials
- Filtration
- Forced Degradation Studies
- Formulation Development
- Controlled Release
- Genomics and Screening
- Auditing
- Hazardous Waste Management
- IND/NDA Submissions
- Software & Technology
- 21CFR11 / Annex 11
- Data Management
- Process Automation
- Lead Optimization
- Lipids/Phospholipids
- Supply Chain & Logistics
- Lot Release Testing
- Aseptic Fill-Finish
- Bioequivalence
- Clinical Trial Materials
- Controlled Substances
- Ethical
- Generics
- Inhalables
- Liquids
- Nasal Delivery
- Nutraceuticals
- Oligonucleotides
- Ophthalmics
- OTC
- Parenterals
- Small Volume
- Peptides
- Proteins
- Solutions & Suspensions
- Pre-filled
- Vaccines
- Mass Spectrometry
- Materials Analysis
- Clinical Studies
- Metabolic Analysis
- Process Development
- Micro FT-IR Analysis
- Microbiological Control Services
- Microbiological Testing
- Microencapsulation
- Microscopic Analysis
- Nonclinical Research
- Anti-Counterfeiting
- Closures
- Design & Testing
- Contract Development
- Aseptic Fill-Finish
- Glass
- Labelling
- Particle Characterization
- Particle Size Analysis
- Particle Size Classification
- Pharmacodynamics
- Pharmacogenomics
- Physical Testing
- Pilot-Scale Filling
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Analytical Technology (PAT)
- Process Characterization
- Process R&D
- Process Validation Studies
- Project Management
- Quality QA/QC
- R&D Services
- RNAi Technology
- Serialization
- Shipping
- Size Reduction
- Stability
- ICH
- Statistical Analysis
- Sterility Testing
- Sterilization
- Supply Chain Auditing
- Supply Chain Management
- System Integration
- Target Profiling
- Training
- Trays
- UV-VIS Spectrophotometer Analysis
- Validation
- Clinical
- Cleaning Equipment
- Virology
- Warehousing
- Water Testing
- Wet Chemical Analysis

Exelead Biopharma a MilliporeSigma company continues to support the pharmaceutical industry with its extensive range of services designed to meet the evolving needs of drug development and manufacturing. For more information, visit exeleadbiopharma.com.

Certification
United States FDA, Europe EMA, Germany PEI, UK MHRA, Canada Health Canada

Capabilities

Contact Information

Address
6925 Guion RoadIndianapolis, IN, 46268, United States
Zip/Post Code
46268

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