Biosafety testing at its most rigorous compliance
We provide significant capabilities and programs for cGMP compliant biosafety testing. Our scientific team has extensive industry experience in commercial biopharmaceutical development. We are also a reliable provider of contract testing services.
Catalent Benefits
- Product development services and assays
- A comprehensive range of options to meet your needs
- Highly trained team of scientists with a high PhD ratio.
- Successful track record
- Development and CMC support for our client's FDA (CBER/CDER), MHW, and EMEA submissions
- Full-service approach
- Including client laboratories for viral clearance studies
Catalent Services
Our services are designed to facilitate development from late target discovery and pre-clinical evaluation through clinical scale manufacturing in fill and finish of liquid or lyophilized biopharmaceutical drugs.
- Viral Clearance
- An important step in demonstrating the safety of your biopharmaceutical product is validating the capacity of key process steps to remove or inactivate virus.
- Catalent can help you choose the best pathway and steps to evaluate in order to assess the viral clearance potential of your manufacturing process. We will help you select the appropriate viruses to use and design GLP-compliant studies.
- When evaluating a viral inactivation step (such as solvent/detergent, pasteurization, or dry heat), we make sure that the kinetics of inactivation is determined.
- When evaluating a viral removal step (such as chromatography or nanofiltration), we ensure that infectivity balance is demonstrated.
- We use high titer virus stocks so that the maximum clearance for your process step can be demonstrated. Validated infectivity assays are used to evaluate samples in real time.
- We can also perform your entire study or let you use one of our dedicated client labs to do the processing while we perform the virus assays. While visiting Catalent, we can provide you with an office with telephone and data ports.
- In-process and lot release testing
- We perform assays for all stages of biopharmaceutical manufacturing, including in-process tests of bulk harvests and purified bulk for:
- Contaminating agents
- cGMP-compliant lot release testing for biocontaminants
- Host cell proteins
- Bioassays for potency
- Analytical assays for structural and contaminant determination
- Stability
- Our biological testing expertise is completely integrated into our stability protocols. We offer the entire spectrum of ICH conditions to support standard stability studies, photostability, and stress testing. Our multiple chambers (>35) are continuously monitored for temperature and humidity by the Kaye system and a hardwired security system. In addition, our equipment undergoes routine calibration and boasts the additional safeguard of full generator backup.
- Method development and validation
- Backed by our highly trained technical experts, we have successfully developed and validated complex release assays for products in Phase I through commercialization. The diversity of these test articles range from recombinant proteins to therapeutic viruses and attenuated bacterial vaccines. We can help you design the scientific path to meet the accuracy, linearity, precision, specificity, ruggedness and robustness guidelines set by regulatory agencies.
- Assays offered
- Molecular biology
- Detection of residual host DNA
- Virus detection by PCR
- Virology
- Infectivity assays
- Characterized, high titer virus stocks for viral clearance
- Validated assays
- Microbiology
- Sterility testing (USP, 21 CFR)
- Mycoplasma testing (PTC direct method, indirect method, PCR)
- Endotoxins (LAL by gel-clot method or kinetic-chromogenic method)
- Bioburden
- Cell biology
- Isozyme analysis
- ELISA
- Cell culture
- Western blots
- Flow cytometry
- Electrochemolumisence
- Analytical
- GC
- HPLC
- AAA
- Glycan analysis
- Structural analysis
- Mass spectroscopy
Facilities
- RTP, North Carolina, U.S.A. - Center for Development and Analytical
- General stats
- Over 330+ personnel in 200,000 sq. ft. of laboratory space
- 9,500 sq. ft. of GMP manufacturing for CTMs
- Project director based work teams
- Effective resource design including:
- Project management
- Project directors
- QA
- Scientific staff supported with administrative assistants
- Special material handling
- DEA-controlled substances
- Cytoxics
- High potency
- Light -moisture-, and oxygen-sensitive compounds
- Cephalosporin/penicillin
- BSL 2/3
- Hormonals
- Radioactive licenses
- Laboratory facilities
- 6 buildings in Southport Business Park
- 200,000 sq. ft. laboratory space
- 22,750 cu. ft. ICH stability
- cGMP manufacturing
- 9,500 sq. ft.
- Respiratory
- Sterile (liquid/lyo)
- Phase I/II scale
- Operational excellence
- Visual management of workload
- Metrics driven
- Value-stream approach
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