Biopharma

Helps in supporting cell line development, gene therapy, vaccine development, recombinant protein production, and molecular characterization.

• DNA and RNA sequencing
• Next-generation sequencing (NGS)
• Sanger sequencing
• Gene synthesis
• Plasmid characterization
• PCR and qPCR testing
• Digital PCR
• Gene expression analysis
• Genetic identity testing
• Molecular assay development
• Sequence verification

Helps in developing new biologics, therapeutic proteins, and other innovative molecules.

• Genetic engineering and Recombinant DNA technology
• Protein expression and characterization
• Cell-based assays and screening
• Proteomics
• Biomarker research
• Bioinformatics and computational biology
• Antibody discovery and development

Helps in assessing potential biological contamination and supporting the safety evaluation of biological medicines.

• Cell bank characterization
• Master and working cell bank testing
• Mycoplasma testing
• Viral safety testing
• Virus clearance studies
• Sterility and endotoxin testing
• Host cell protein analysis
• Biological raw material testing

Helps in supporting contamination prevention, aseptic manufacturing, and the microbiological quality of pharmaceutical products.

• Sterility testing
• Bacterial endotoxin testing
• Bioburden testing
• Cosmetics and finished product testing
• Microbial identification
• Water system microbiology
• Microbial limit testing
• Antimicrobial effectiveness testing, where applicable

Helps in developing advanced treatments for genetic disorders, cancer, and other serious diseases.

• Cell therapy development
• Gene therapy development
• Viral vector development and production
• Plasmid DNA manufacturing
• Cell expansion and culture
• Cell processing and purification
• Vector characterization
• Potency testing
• Identity and purity testing
• Safety testing

Availability depends on the provider’s specialized facilities, technologies, and regulatory capabilities.

Helps in supporting Phase I, Phase II, Phase III, and, where applicable, Phase IV clinical studies.

• Clinical trial laboratory testing
• Clinical bioanalysis
• Biomarker testing
• Central laboratory services
• Clinical sample management
• Sample collection kit preparation
• Biological sample storage
• Clinical trial logistics
• Clinical data management
• Statistical analysis
• Clinical trial supply support
• Clinical packaging and labeling

Helps in developing stable formulations for biologics, vaccines, therapeutic proteins, and injectable medicines.

• Preformulation studies
• Formulation screening
• Excipient compatibility studies
• Protein formulation development
• Injectable formulation development
• Lyophilized formulation development
• Buffer optimization
• Solubility and stability studies
• Drug delivery system development
• Container closure compatibility studies
• Scale-up and process optimization

Helps in supporting shelf-life determination, storage recommendations, product development, and regulatory submissions.

• Accelerated stability studies
• Long-term stability studies
• Intermediate stability studies
• Photostability testing
• Temperature excursion studies
• Freeze-thaw stability testing
• In-use stability testing
• Forced degradation studies
• Stability sample storage and management

Helping biopharma companies prepare scientific and quality documentation for regulatory review.

• Regulatory strategy development
• CMC documentation
• Investigational New Drug (IND) application support
• Biologics License Application (BLA) support
• Marketing authorization documentation
• Common Technical Document (CTD) preparation
• Regulatory dossier preparation
• GMP compliance consulting
• Regulatory gap assessments
• Audit preparation
• Inspection readiness
• Regulatory submission support

The specific requirements depend on the product, development stage and target market.