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Biopharmaceutical
development services

• Overview

• Gene expression

  • Overview
  • GPEx® expression technology
  • Monoclonal antibody (mAb) production

• Biomanufacturing
• Biopharm product development
• Biosafety testing
• Bioassay development
• Bioanalytical PK/ immunogenicity
• Clinical manufacturing

Product development
services

• Overview

• Oral

  • Overview
  • Preformulation
  • Formulation development
  • Proprietary technologies
  • Clinical manufacturing

• Pulmonary and nasal

  • Overview
  • Preformulation
  • Formulation and product testing
  • Clinical manufacturing

• Sterile

• Analytical

  • Overview
  • Stability testing and storage
  • Metal analysis
    (AKA trace analysis)
  • Compendial testing
  • Mass spectrometry
    (GC/MS and LC/MS)

• Structural chemistry

  • Overview
  • Fourier transform infrared spectroscopy
  • Extractables routine control methods
  • Forced (Stressed) API and drug product degradation
  • Mass spectrometry (LC-MS, LC-MS, GC-MS)
  • Nuclear magnetic resonance (NMR)
  • Isolation
  • Characterization
  • Reference standard synthesis / qualification
  • Proteins

• Stability
• Microbiology
• Chemical development

Clinical supply services

• Overview
• Comparator Supply Services

Regulatory consulting services

Catalent Pharma Solutions provides 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.

Our offerings include:

• Product development services and assays-a comprehensive range of options to meet your needs
• Successful track record-of 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, and a project management group dedicated specifically to biosafety testing services

Cell Bank Characterization-We perform all the characterization assays required by the FDA regulatory agencies worldwide for mammalian Master and Working Cell Banks (MCB, WCB), including infectivity, electron microscopic, and PCR based assays for viruses, isoenzyme analysis and karyotyping for identity, microbial and other adventitious agent contaminants including sterility and mycoplasma assays.

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 will make sure that the kinetics of inactivation is determined.
• When evaluating a viral removal step (such as chromatography or nanofiltration), we will make sure 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 do 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, and 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 back-up.

Method Development and Validation-Our scientific staff is comprised of technical experts with a high Ph.D. ratio. 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

Product-enhanced reverse transcriptase assay

Restriction map analysis

Plasmid copy number determination

Plasmid retention by selective marker sensitivity

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

Radioimmunoassay

ELISA

Tissue culture

Western blots

Flow cytometry

Analytical

GC

HPLC

AAA

Glycan analysis

Structural analysis

Mass spectroscopy

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.