Profacgen's CDMO services deliver comprehensive support across the entire biologic product development continuum—from early feasibility assessment through process development, analytical strategy, and clinical-ready manufacturing. Our CDMO model is structured to support program with predictable milestones, quality-aligned execution, and clear documentation that aligns with development, regulatory, and commercialization requirements.
Whether your project is advancing toward IND, scaling clinical supply, or preparing for late-stage development, our CDMO services provide an integrated pathway that minimizes risk and accelerates decision-making.
Choosing a CDMO is a strategic decision that directly impacts your program's timeline, cost structure, and regulatory readiness. Unlike standalone service providers, a full CDMO partner:
For program leaders, the core value of engaging a CDMO is the seamless integration of capabilities—from discovery insights to clinical supply—under a unified quality and project management framework.
Profacgen's CDMO engagements are ideal at stages such as:
If your team needs predictable, documented processes, clear handoffs between development phases, and accountability for deliverables across functional domains, a CDMO partnership can dramatically enhance development clarity and minimize operational risk.
Profacgen offers a coordinated suite of services designed to accelerate development and manufacturing while ensuring compliance with regulatory and quality expectations.
Feasibility Assessment and Program Planning
This early assessment aligns technical strategy with regulatory objectives and resource planning.
Process and Analytical Development
These steps ensure your process not only works but is robust, scalable, and documentable—critical for regulatory confidence.
cGMP Manufacturing Execution
Our GMP execution is designed not only for material production, but for generating quality documentation that aligns with IND and regulatory expectations.
Integrated Quality and Regulatory Support
Regulatory documentation is not an afterthought—it is built into the CDMO workflow to support downstream interactions and submissions.
Profacgen's cGMP manufacturing facility is designed and constructed in full compliance with current regulatory guidelines in the United States and the European Union. Supported by a high-standard quality system, a comprehensive quality management framework, and an experienced QA team, the facility effectively meets global regulatory requirements for biological product manufacturing.
| Milestone | Service | Delivery |
| Transfer and confirmation of analytical methods | Transfer and confirmation of key central control testing methods and release testing methods | The analysis method completes the transfer according to the predetermined scheme |
| Cell line transfer and QC tests | MCB and WCB transfer Mycoplasma and sterility test | Complete the transfer according to the agreed standard and time |
| Fermentation and purification process transfer and validation | Transfer confirmation of cell culture and purification process: risk assessment, narrowing the model, establishing a batch (3L / 10L) of engineering batch to verify the transfer process | Repeat the production process to obtain products that meet the quality requirements |
| 50L amplification confirmation | One batch of 50L process amplification | |
| Release of raw materials and consumables (culture medium, feed supplement, filler, packaging material, supplementary material, etc.) | Purchase and release according to the customer's project bill of materials and release standards | All raw and supplementary material shall be purchased and released according to their own standards |
| Stock solution GMP document establishment (SOP and batch record) | Preparation of GMP documents, including process procedures, SOP, batch records and training records | Comply with relevant requirements of GMP document system |
| Stock solution production meeting cGMP requirements | A batch of stock solution production meeting cGMP requirements | The production complies with GMP quality management specifications, and the samples are tested as qualified according to the standards |
| Stock solution batch release test | Stock solution batch release test | Complete release inspection according to GMP quality management specification |
| Preparation GMP document establishment (SOP and batch record) | Preparation of GMP documents, including process procedures, SOP, batch records and training records | Comply with relevant requirements of GMP document system |
| Aseptic filling | Simulated filling of culture medium Filling of a batch of sterile water agent | The production complies with GMP quality management specifications, and the samples are tested as qualified according to the standards |
| Finished product release inspection | Stock solution batch release test | Complete release inspection according to GMP quality management specification |
The following examples show how CDMO engagements commonly support biologics development. They are illustrative and not linked to specific clients.
Program Context:
A biotherapeutic development program approaching IND submission required coordinated execution across process development, analytical strategy, and cGMP manufacturing. The client sought to minimize handoffs and ensure consistency across technical activities and regulatory documentation.
Objective:
To deliver cGMP-compliant batch material together with quality and manufacturing documentation suitable to support IND filing and regulatory review.
Approach:
Profacgen conducted an initial feasibility and readiness assessment, followed by alignment of upstream and downstream process strategies with analytical and quality requirements. cGMP batch production was executed under controlled conditions, with structured collection of manufacturing records, analytical data, and quality summaries.
Outcome:
The program completed IND-enabling batch production on schedule, supported by coherent quality documentation and data packages aligned for regulatory submission and review.
Program Context:
Following successful pilot-scale production, a development team required scalable cGMP manufacturing and release testing to support Phase I clinical supply. Ensuring process consistency and regulatory alignment during scale-up was a primary concern.
Objective:
To establish scalable manufacturing processes, produce multiple clinical batches, and align release criteria with regulatory expectations for clinical dosing.
Approach:
Profacgen refined upstream and downstream processes to support scale-up, aligned analytical methods for release and in-process testing, and executed controlled cGMP production runs. Release testing and documentation were coordinated to ensure traceability across development stages.
Outcome:
Consistent, releasable clinical material was delivered in accordance with dosing timelines, supported by traceable documentation spanning process development, manufacturing, and quality control.
Fill out this form and one of our experts will respond to you within one business day.