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IND-enabling Non-cGMP Production and cGMP Manufacturing
IND-enabling Non-cGMP Production and cGMP Manufacturing
Profacgen's IND-Enabling Non-cGMP Production and cGMP Manufacturing service supports development programs that require strategic supply of material for regulatory enabling activities along with readiness for transition into regulated GMP manufacturing. Our integrated approach addresses both non-cGMP material needs for IND support and the subsequent escalation to compliant manufacturing—helping development teams manage timelines, regulatory expectations, and risk.
Service Highlights at a Glance
End-to-end drug production: preclinical, clinical, and marketed drugs
Flexible manufacturing: non-GMP and cGMP standards
Scalable production: 50L and 200L bioreactors
Fully customizable solutions
Advanced bioreactors & liquid storage with disposable bags
24/7 production, equipment, and facility monitoring
Compliance with FDA, EMA, and ICH guidelines
Why Combine Non-cGMP and cGMP Support
Development programs frequently navigate a transition between early material supply (non-cGMP) and regulated manufacturing (cGMP). The success of this transition can directly influence:
IND submission timelines
Quality outcomes in toxicology or regulatory studies
Risk associated with later process transfer or scale-up
Comparability of material used across preclinical and clinical stages
Rather than treating non-cGMP production and cGMP manufacturing as separate engagements, Profacgen's integrated offering provides:
Continuity of process knowledge
Alignment of documentation and data collection
Reduced risk of "informational gaps" at key decision points
Strategic planning for regulatory-relevant material supply
This approach enables your program to proceed with clarity, prevent unnecessary iterations, and support confidence in regulatory dialogue.
When to Engage This Integrated Service
Engagement is recommended when your program:
Is preparing preclinical toxicology or pharmacology studies that contribute to IND filings
Requires repeatable non-cGMP production to support analytical or formulation development
Anticipates transition of material or process to regulated manufacturing
Needs quality documentation—even for non-cGMP material—to support comparability or risk assessments
Seeks to de-risk process transfer from development to compliant manufacturing
This service is most impactful when planned early, prior to critical decision points such as pre-IND meetings, regulatory dry runs, or finalizing manufacturing pathways.
Core Capabilities You Can Rely On
Profacgen offers a structured engagement that aligns material production, process understanding, and documentation with the needs of IND-enabling strategies and regulated manufacturing.
Non-cGMP Material Production for IND Enabling
Controlled production of protein or biologic material outside of GMP
Documentation suitable for toxicology, bioanalysis, and formulation use
Material supplied with traceability, batch data, and process context
Non-cGMP production under this engagement is executed with attention to data reliability and interpretability, supporting your preclinical risk assessments.
Preparation for cGMP Manufacturing Transition
Process review and gap assessment based on non-cGMP results
Development of scalable process steps amenable to GMP standards
Alignment of analytical methods with future GMP requirements
This early alignment fosters better outcomes during GMP qualification and reduces uncertainty during transition.
cGMP Manufacturing Execution
cGMP batch production with regulatory quality system oversight
In-process controls and documentation supporting compliance
Integration of release testing and analytical verification
Our GMP manufacturing is structured to support clinical or IND filing material, with traceable quality systems and documentation that meet regulatory expectations.
Documentation and Quality Planning
Material history documentation and traceability for non-cGMP supply
Transition-ready process narratives and batch summaries
Reports designed for regulatory use and internal decision-making
Documentation across both non-cGMP and cGMP activities is planned to minimize gaps and support comparability discussions.
Drug Substance (DS) and Drug Product (DP) Production
Complete GMP services: upstream cell culture, downstream protein purification, preparation filling, and finished product packaging
Multi-scale protein and antibody production: 50L–2000L
Flexible cell culture lines to meet diverse process requirements
Advanced purification with automated chromatography and ultrafiltration for high recovery
Preparation production including filling, lyophilization, and packaging
Disposable equipment and consumables minimize contamination risk and shorten production cycles
Quality and Testing Services
Profacgen provides product testing, release, quality standard development, and lifecycle management in line with FDA, EMA, and ICH guidelines.
Process Testing & Control: Expression, protein concentration, osmotic pressure, bacterial endotoxin, sterility, and related parameters
Release Testing: Comprehensive DS and DP testing including identification, purity, impurities, potency, protein content, safety, and routine assays
Stability Studies: Long-term, accelerated, forced degradation, and in-use stability evaluations
The following scenarios illustrate common applications of this integrated approach. They are provided for illustration and do not reference specific client programs.
Scenario 1: Preclinical Supply and cGMP Transition for IND Filing
Program Context:
A development team required consistent and high-quality protein material for preclinical toxicity and bioanalytical studies in preparation for an IND submission. In parallel, they sought to align their processes to facilitate a smooth transition to future GMP manufacturing.
Objective:
Provide reliable non-cGMP material for preclinical assessment while ensuring the process is positioned for seamless scale-up and compliance under regulated GMP conditions.
Approach:
Executed non-cGMP production with thorough documentation and process review. Designed a scalable process strategy to anticipate future GMP requirements. Conducted GMP readiness assessments and implemented compliant manufacturing execution for transition planning.
Outcome:
Delivered high-quality material suitable for regulatory decision-making, accompanied by detailed process documentation that supported efficient planning for subsequent GMP manufacturing.
Scenario 2: Integrated Production for Formulation and Clinical Supply
Program Context:
A biologics program required controlled and fully documented material for formulation optimization and toxicology studies while planning for clinical supply under cGMP standards.
Objective:
Provide repeatable non-cGMP material for development work and establish a clear strategy for transitioning to cGMP clinical manufacturing.
Approach:
Performed structured non-cGMP production, aligning analytical methods and completing comprehensive gap assessments. Developed a stepwise GMP transition plan and executed preliminary compliant runs to ensure smooth scale-up and process readiness for clinical supply.
Outcome:
Delivered high-quality, documented non-cGMP material for formulation and toxicology studies. Successfully implemented the GMP transition plan, enabling efficient cGMP manufacturing and ensuring clinical supply met regulatory and quality expectations.
Q: What does "non-cGMP" mean in an IND-enabling context?
A: Non-cGMP production refers to controlled material production outside of formal GMP compliance but executed with sufficient documentation and process context to support development decisions, preclinical studies, or analytical work associated with an IND strategy.
Q: Is non-cGMP material acceptable for regulatory preclinical studies?
A: Yes—provided the material is documented, reproducible, and fit for its intended use. Non-cGMP material is commonly used for toxicology, pharmacology, formulation, and analytical method development when clearly justified.
Q: How does this integrated service reduce risk?
A: By aligning non-cGMP production with future GMP expectations early, you minimize surprises during process transfer, reduce documentation gaps, and anticipate analytical and quality needs relevant to regulatory submissions.
Q: What documentation will I receive?
A: Documentation typically includes production records, material history, analytical summaries, process context assessments, and GMP batch traces—all tailored to program needs.
Q: How does Profacgen handle transition planning?
A: Transition planning includes gap analysis, process risk assessment, control definition, and mapping documentation needs from non-cGMP stages to cGMP readiness.
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