From Molecule to First in Human: Comprehensive CMC Development & Manufacturing Strategy
Ensuring a Seamless Path from Drug Development to Clinical and Commercial Success
At 3Biotech, we provide end-to-end Chemistry, Manufacturing, and Controls (CMC) services, ensuring that your drug substance and drug product are developed, manufactured, and controlled according to regulatory and quality standards (ICH, EMA, FDA).
A well-defined CMC strategy is critical for regulatory approval, scale-up feasibility, and commercial readiness. Our CMC development services cover both small molecules and biologics, with a strong focus on analytical characterization, process development, GMP manufacturing, regulatory compliance, CDMO selection, and clinical supply chain management.
CMC Strategy Development, Program Management & CDMO Selection
CMC is not just a regulatory requirement - it is the foundation of a drug’s success. We develop a tailored CMC strategy from early-stage development through late-stage commercial readiness, ensuring that quality, timelines, and costs are optimized.
Key Services
CMC Strategy & Roadmap: We define a phased approach from early development to commercial scale, aligning with FDA, EMA, and ICH Q8-Q11 guidelines.
Risk Assessment & Gap Analysis: Identification of process bottlenecks, manufacturability risks, and regulatory gaps to mitigate delays and CMC failures.
Regulatory CMC Dossier Preparation: Preparation and review of IMPD, IND, BLA, MAA, NDA, and CMC sections, ensuring regulatory alignment.
CDMO Selection & Oversight: Leveraging our global network of leading CDMOs, we identify the most qualified partners for:
Process development (Drug Substance & Drug Product)
Clinical & commercial GMP manufacturing
Analytical method transfer & validation
Supply chain security & logistics
Regulatory compliance & GMP audits
Our strong partnerships with top-tier CDMOs worldwide enable us to match your project with the best manufacturing partner, ensuring efficiency, cost-effectiveness, and compliance with global regulatory standards.
Analytical Development: Ensuring Quality & Regulatory Compliance
A robust analytical strategy is fundamental to characterizing drug substances and drug products, ensuring batch consistency, purity, and stability. Our analytical expertise covers both small molecules and biologics.
Key Services
Method Development & Validation: Development and qualification of identity, purity, potency, and stability methods.
Physicochemical Characterization:
Small Molecules: HPLC, LC-MS, dissolution testing, impurity profiling.
Biologics: SEC-HPLC, cIEF, SDS-PAGE, glycan analysis, mass spectrometry.
Forced Degradation & Stability Studies: ICH Q1A/B-compliant stability testing for regulatory submission.
Comparability & Release Testing: Lot-to-lot consistency studies and in-process control testing for GMP manufacturing.
GMP Manufacturing & Good Manufacturing Practices Compliance
We ensure GMP compliance across all stages of drug manufacturing, from clinical batch production to commercial supply, mitigating risks associated with process variability and regulatory non-compliance.
Key Services
GMP Strategy & Regulatory Compliance:
Preparation for pre-approval inspections (PAI)
Quality risk management in alignment with ICH Q9
Clinical Batch Production & Tech Transfer:
Coordination of GMP batch manufacturing at CDMOs
Scale-up and technology transfer from lab to GMP facilities
Supply Chain & Raw Material Qualification:
Vendor selection for raw materials and excipients
GMP audits and quality assurance oversight
Drug Substance Process Development (USP & DSP)
Whether working with small molecules or biologics, we design and optimize upstream (USP) and downstream (DSP) processes to ensure scalability, reproducibility, and cost-effectiveness.
Small Molecules: Chemical Synthesis & Purification
Route scouting & process optimization
Crystallization & polymorph control
API impurity profiling & removal strategies
Process safety assessment & scale-up feasibility
Biologics: Upstream (USP) & Downstream (DSP) Optimization
Upstream Process (USP) Development:
Cell line development & selection (CHO, HEK, microbial)
Fed-batch & perfusion process optimization
Titer & yield optimization strategies
Downstream Process (DSP) Development:
Chromatography optimization (Protein A, IEX, HIC, SEC)
Filtration & viral clearance validation
High-purity recovery strategies (>90% monomer content)
Drug Product Formulation & Process Development
The right formulation strategy ensures that a drug is stable, bioavailable, and manufacturable at scale. We develop liquid, lyophilized, and novel delivery formulations tailored to your route of administration and patient needs.
Small Molecule Formulation Development
Solubility & bioavailability enhancement (e.g., amorphous solid dispersions, nanoparticles).
Oral (tablet, capsule, liquid) and parenteral formulation design.
Excipient selection & compatibility studies.
Biologic Drug Product Formulation
Protein stability & aggregation minimization strategies.
Liquid vs. lyophilized formulation optimization.
Buffer selection for long-term stability.
Delivery system optimization (IV, SC, inhalation, oral biologics).
Clinical Supply Management: Ensuring Timely and Compliant Drug Delivery
Reliable clinical supply is essential for successful clinical trials. We manage end-to-end clinical trial supply logistics, ensuring that GMP-compliant drug product reaches trial sites on time and in optimal condition.
Key Services
Clinical Batch Manufacturing & Packaging
Production of GMP-compliant clinical trial materials (CTM)
Primary & secondary packaging tailored to trial requirements
Global Distribution & Supply Chain Logistics
Coordination of cold-chain & temperature-sensitive shipments
Import/export compliance with FDA, EMA, MHRA, and other regulatory bodies
Labeling & Blinding Services
Development of randomized, blinded, and open-label clinical supplies
Compliance with Good Clinical Practices (GCP) and regional regulatory requirements
Real-Time Inventory Management & Adaptive Resupply
On-demand drug supply monitoring to prevent shortages
Adaptive resupply strategies to mitigate delays & reduce waste
By integrating supply chain management with clinical development, we ensure that your investigational product is delivered efficiently and compliantly, minimizing risks associated with trial delays.
Why Choose 3Biotech for CMC Development?
Comprehensive Expertise in small molecules and biologics
Regulatory Alignment (ICH Q6-Q12, FDA, EMA)
End-to-End Process Development from lead candidate to GMP manufacturing
De-risked Tech Transfer & Scale-Up Strategies
Global Network of Top-Tier CDMOs for cost-effective, high-quality manufacturing
Robust Clinical Supply Management to ensure timely trial execution
At 3Biotech, we take a strategic, science-driven, and regulatory-compliant approach to CMC development, ensuring that your drug candidate moves seamlessly from early development to clinical trials and commercial success.
What is Chemistry, Manufacturing, and Control (CMC) in pharma?
Chemistry, Manufacturing, and Controls (CMC) encompasses all activities related to the development of drug substances and products. This includes formulation, process optimization, analytical testing, and ensuring regulatory compliance.
CMC ensures the physical and chemical characteristics of drug products are assessed to maintain quality and consistency throughout manufacturing.
What is process development and how does it support Good Manufacturing Practice (GMP) manufacturing?
Process development refines and optimizes production methods for scalability, consistency, and regulatory compliance in GMP manufacturing.
It involves documenting processes to ensure consistent quality, minimize risks, and guarantee product safety, while establishing robust systems that meet regulatory standards.
How do you select the right Contract Development and Manufacturing Organization (CDMO) for your project?
Choosing the right CDMO involves looking at several factors, including their experience, regulatory track record, technical skills, ability to meet quality standards, communication, and cost efficiency. The goal is to find a partner that matches your project needs and supports your long-term objectives.
How does 3Biotech manage technology transfer to Contract Development and Manufacturing Organizations (CDMOs)?
3Biotech ensures smooth and efficient technology transfer to CDMOs by employing a systematic, structured approach that includes:
Comprehensive Documentation: Preparation of detailed technical packages, including Master Batch Records (MBR), Standard Operating Procedures (SOPs), analytical methods, and stability protocols.
Clear Communication and Coordination: Active project management with regular meetings to maintain alignment, clarify technical details, and proactively address issues.
Technical Oversight: On-site and remote support to ensure the accurate implementation of processes, methods, and quality controls, thereby guaranteeing consistency and compliance.
Risk Management: Proactive identification and mitigation of potential risks associated with scale-up and production, ensuring quality standards and timelines are met.
Through this integrated approach, 3Biotech secures effective and reliable technology transfer, reducing risk, cost, and timeline uncertainties in collaboration with CDMOs.
What are the phases of Chemistry, Manufacturing, and Control (CMC) development for biologics?
The phases of Chemistry, Manufacturing, and Control (CMC) development for biologics include cell line development, process optimization, formulation, analytical testing, and regulatory submission.
These phases cover pre-clinical/Phase I, Phase II, Phase III and commercial launch stages, with each phase focusing on refining the manufacturing process, optimizing formulation, validating analytical methods, and meeting regulatory requirements.
What is the role of comparability testing in biologics manufacturing?
Comparability testing in biologics manufacturing ensures that any changes in the manufacturing process do not negatively affect the quality, safety, or efficacy of the final product. It involves comparing pre- and post-change products to verify their equivalence and demonstrate that the changes are acceptable.