First-class expertise in developing and evaluating large molecules
Catalent’s biopharmaceutical experts have helped hundreds of companies make the difficult path through the drug development cycle faster and more successfully. In biopharmaceutical development, we focus on developing and analytically evaluating large molecule pharmaceuticals. We have extensive experience in preformulation analysis and formulation development, as well as biomolecule structural characterization. We also have the ability to perform clinical scale fill/finish manufacturing for liquid and lyophilized product.
Our experience includes extensive work with:
- Recombinant proteins
- Pegylated conjugates
- Monoclonal antibodies
- Peptides
- Oligonucleotides (siRNA, antisense, aptamers)
Catalent Benefits
We recognize that successful development requires great science, a strong technological infrastructure, and an understanding of what you need for your submission’s regulatory approval:
- Extensive experience in biopharmaceutical product development
- Positive history of interactions with regulatory authorities
- State-of-the-art analytical instrumentation
- Global facilities backed by a history of excellent GMP compliance
Catalent Services
- Biomolecule Structural Characterization
- Our testing services - designed to support pre-IND, Phase I, II, and III clinical trials and post BLA/NDA submissions - analyze biopharmaceutical products to demonstrate that predetermined specifications are met and provide evidence that your protein is safe, stable, and will maintain efficacy in the final product formulation. Supported by our advanced and highly sophisticated equipment, we are able to employ a vast array of highly sensitive analytical techniques to characterize reference standards, determine impurity profiles, and identify degradation products:
- N-terminal sequencing
- Amino Acid Analysis (AAA)
- Extinction coefficient determination
- Carbohydrate analysis
- Peptide mapping
- Circular dichroism (thermal stability)
- High order structure
- Preformulation development
- We have years of experience designing preformulation studies to evaluate and select formulations, develop stability-indicating assay methods and analyze the effects of manufacturing changes on the product. We have extensive capabilities in:
- Chromatographic system development
- Thermal analysis
- Physical and chemical accelerated stress testing
- Identification of conditions for optimal stability
- Selection of excipients and stabilizers
- Analytical method development and validation
- Formulation development
- We are experts in creating dosage formulation design for liquid and lyophilized product:
- Test components for suitability in drug-product formulation
- Stability-indicting methods to evaluate their effect on the native structure and function of the biomolecules
- Incorporate product testing under diverse conditions, leading to a formulation that meets specifications and maximizes drug stability
How It Works
Components of a formulation development study include:
- Method qualification and validation
- Container/closure selection
- Lyophilization cycle development
- Specification development
- Evaluation of degradation products
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-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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