Biologics Development and CMC Solutions
At DSI, we provide comprehensive biologics consulting services, ensuring a seamless transition from early development through commercialization. Our team of industry-leading experts delivers end-to-end Chemistry, Manufacturing, and Controls (CMC) regulatory consulting, drug development strategies, and quality system solutions to support compliance and accelerate approvals. Whether navigating an Investigational New Drug (IND), Biologics License Application (BLA), or post-approval changes, our tailored solutions help companies bring innovative biologics to market efficiently and successfully.
Our expertise spans all aspects of biologics development, including cell and gene therapies, monoclonal antibodies, recombinant proteins, vaccines, and biosimilars—ensuring your product meets stringent regulatory requirements while optimizing manufacturability and scalability.
Our mission is to provide guidance and value at every step of the drug development process, from product conception through commercialization.
Regardless of the stage of your product’s development, the DSI team brings the technical expertise and industry experience necessary to step in and provide immediate hands-on support to your team. We are one of the most experienced biologics consulting companies.
Regulatory and CMC Consulting for Biologics
Our biologics consultants bring deep expertise in CMC regulatory strategy, submission preparation, and compliance to help companies navigate FDA, EMA, and other global regulatory agencies.
Comprehensive Regulatory and CMC Expertise
- Regulatory Strategy and Planning: We provide end-to-end regulatory support, from pre-IND meetings through BLA/MAA submissions, ensuring a strategic pathway to approval.
- CMC Regulatory Writing and Submission Support: Our team authors, reviews, and publishes INDs, BLAs, CTDs, IMPDs, and post-approval submissions with precision.
- Agency Engagement & Meeting Support: We prepare briefing documents, conduct risk assessments, and represent clients in regulatory meetings with FDA, EMA, and other authorities.
- Post-Approval CMC Submissions: Our experts manage all aspects of post-market variations, annual reports, and lifecycle management to ensure ongoing compliance.
Biologics Process Development & Manufacturing Support
A well-defined process development and manufacturing strategy is critical for biologics. DSI provides hands-on expertise in scaling up processes and ensuring regulatory compliance across all stages of development.
Process Development & Scale-Up
- Early-Stage Development & Process Optimization: We help develop scalable, reproducible biologics processes from lab-scale to full commercial manufacturing.
- CMC Strategy for IND & BLA Preparation: Our team ensures that your CMC strategy aligns with regulatory expectations and accelerates approval timelines.
- Technology Transfer & CDMO Management: We select, qualify, and manage CDMOs to ensure seamless tech transfer and GMP compliance.
- Materials & Equipment Selection: We assist in sourcing high-quality raw materials and selecting scalable equipment to prevent supply chain disruptions.
- Process Validation & Commercial Readiness: Our team ensures that biologic products meet FDA and EMA validation requirements to facilitate commercialization.
Upstream and Downstream Process Development
Efficient upstream and downstream processing is vital for biologic product success. DSI offers extensive support across all process stages.
Upstream Operations (Cell Culture & Fermentation)
- Cell Line Development & Master Cell Bank Strategy: Optimizing cell line stability, viability, and productivity to enhance biologic production.
- Media Optimization & Bioreactor Scale-Up: Developing customized media formulations and scalable bioreactor processes to maximize yield and consistency.
- Harvest & Clarification Strategies: Ensuring efficient cell separation and recovery techniques to enhance product purity and yield.
Downstream Operations (Purification & Formulation)
- Chromatography & Filtration Optimization: Designing purification processes that maximize yield, purity, and scalability.
- Viral Clearance & Contaminant Removal: Ensuring robust viral inactivation and clearance strategies to meet regulatory requirements.
- Final Drug Substance Formulation & Stability: Developing stable formulations that maintain product integrity throughout storage and distribution.
Analytical & Quality Control Services for Biologics
A robust analytical strategy ensures biologic product safety and efficacy. DSI offers comprehensive analytical development and quality control solutions.
Analytical & QC Services
- Method Development, Qualification & Validation: Developing and validating ICH-compliant analytical methods for biologic product testing.
- Release & Stability Testing: Implementing stability programs to support shelf-life determinations and regulatory compliance.
- Reference Standard Qualification: Establishing reference standards to ensure consistency in biologic manufacturing.
- Extractables & Leachables Assessments: Conducting risk evaluations to ensure container closure compatibility and patient safety.
Quality Assurance & GMP Compliance
Ensuring quality and compliance with GMP regulations is essential for biologics. Our team provides tailored quality assurance strategies to mitigate risk and maintain regulatory compliance.
Quality Assurance & GMP Solutions
- GMP Audits & Vendor Qualifications: Conducting quality system audits to ensure compliance with FDA 21CFR211 and EMA guidelines.
- Quality System Implementation: Establishing GMP-compliant quality management systems (QMS) to streamline manufacturing operations.
- Inspection Readiness & Compliance Support: Preparing clients for regulatory inspections and audits to ensure a successful outcome.
Post-Approval & Lifecycle Management for Biologics
Maintaining regulatory compliance post-approval is critical for biologic product success. DSI provides ongoing support for CMC variations, manufacturing changes, and regulatory compliance.
Lifecycle Management Services
- Process Validation & Continuous Improvement: Ensuring compliance with post-approval validation and process optimization requirements.
- Post-Approval CMC Variations (PAS, CBE, Annual Reports): Managing CMC changes and regulatory updates efficiently.
- Supply Chain & Cold Chain Management: Optimizing logistics for temperature-sensitive biologic products to ensure quality and stability.
Why Choose DSI for Biologics Development?
Your Trusted Partner in Biologics CMC & Regulatory Excellence
- Proven Track Record: Our team of 60+ SMEs has successfully guided numerous biologics and cell & gene therapies through regulatory approval.
- Seamless Execution: We provide both strategic guidance and hands-on support to ensure your project stays on track.
- Global Regulatory Expertise: We specialize in FDA, EMA, and ICH regulations, ensuring compliance across international markets.
- End-to-End Solutions: From early-stage development to BLA submission and post-market compliance, we offer a comprehensive suite of services.
- Commitment to Quality & Compliance: We prioritize client collaboration, meticulous documentation, and compliance-driven project management.
