uBriGene offers full regulatory support, from pre-IND to BLA, DMFs, and expedited programs, with expertise across the US, China, EU, and more.
uBriGene’s experienced regulatory affairs team supports the entire lifecycle of advanced therapy product development, from pre-IND to BLA, as well as DMFs in various countries, including the United States, Canada, China, the European Union, and Australia.
As a leading ATMP CDMO provider, uBriGene offers regulatory services for CMC sections as part of its CDMO service package.
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Automated closed-system technology for manufacturing ensures sterility with functionally closed disposables, minimizes operator errors through pre-programmed steps, and enhances consistency by reducing variability. It also reduces technician hands-on time and lowers production costs.
From pre-IND to BLA, DMFs, and expedited programs
Expertise across the US, China, EU, Canada, Australian, and more
With extensive experience across international regulatory authorities in advanced therapies, we help you navigate the complexities of the regulatory landscape. Our regulatory services support submissions from pre-IND and IND to pre-BLA, BLA, and beyond.
Key services include:
Risk assessment and management
Preparation and submission of expedited program and designation applications (ODD, FTD, BTD, RMAT, PRIME) to US FDA, China NMPA, and EMA
Regulatory support for CMC sections of pre-IND, IND, pre-BLA, and BLA submissions, including IMPDs
CTD/eCTD-based submissions to US FDA, China NMPA, Health Canada, and EMA
DMF applications
Amendments and supplements for CMC changes, covering clinical trials (especially pivotal trials) and post-marketing approvals.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
Our fully qualified 293XS cell bank is specifically selected for its exceptional productivity and quality in AAV vector manufacturing, helping to reduce costs for your clinical therapeutic programs.
Provide guidance through the complex, ever-evolving regulatory landscape
Ensure compliance with regional regulatory guidelines and legislation
Mitigate regulatory risks
Reduce potential costs in the later stages of CMC development
Accelerate development and bring therapies to market faster
In the competitive pharmaceutical industry, everyday counts—especially once your product has demonstrated efficacy in clinical studies. A one-month delay in obtaining marketing licensure can mean the difference between being first-in-class or second-in-class.
uBriGene’s regulatory team can help assess the feasibility of obtaining Fast Track Designation (FTD) and Regenerative Medicine Advanced Therapy (RMAT) from the US FDA, Breakthrough Therapy Designation from both the China NMPA and the FDA, and Priority Medicines (PRIME) status from the EMA.
We assist in submitting expedited program applications and liaising with health authorities to secure these designations. These programs offer more frequent interactions with health authorities during development and allow for rolling submissions of your BLA.
Investigator-initiated trials (IITs) are clinical studies designed, conducted, and managed by independent investigators—typically physicians or researchers—using GMP-like materials. These studies offer valuable clinical data on the safety and efficacy of a potential therapeutic program. IITs are often the fastest and most cost-effective route to achieving clinical proof-of-concept, at a fraction of the cost of traditional clinical trials.
uBriGene can support IIT studies, with the resulting data serving as a key factor in determining whether to continue developing your investigational drug. GCP-compliant IIT data can also help reduce the sample size needed for future IND trials, accelerating the development process.
Several critical raw materials from uBriGene (lentiviral helper plasmids, AAV helper plasmids, 293XS cell banks, and HEK293TH cell banks) have DMF on file with the FDA. These DMF numbers can be directly referenced, reducing the review and evaluation process for related drug projects.
| Items | Applications | DMF record |
|---|---|---|
| GMP grade lentiviral vector packaging plasmids | GMP lentiviral vector manufacturing | DMF 27777 |
| GMP grade AAV helper plasmids | GMP AAV Manufacturing | DMF 28890 |
| 293XS cell banks | GMP AAV Manufacturing | DMF 28844 |
| HEK293TH cell banks | GMP lentiviral vector manufacturing | DMF 29108 |
| GMP grade Ubrinuclease | Remove nucleic acid removal during GMP production | DMF 29414 |
| GMP grade Cas9 proteins, mRNA | Gene editing | DMF 29884 |
*Outsourced testing
Learn about CAR-T production process & regulatory guidelines.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
Learn more details of our RNA-LNP manufacturing and capabilities.
Discover how uBriGene helped our client to receive FDA IND clearance in just nine months.
Yes, we offer regulatory affairs services at any stage of your product development, regardless of whether we manufacture your products.
The timeline varies based on the product and health authorities. We begin preparing your pre-IND and IND package in parallel with CMC, nonclinical, and clinical studies. Once most of the data is available, we can deliver a first draft with placeholders, and the near-final version can be completed within two weeks once all data is ready.
After a case-by-case evaluation and discussion, you may attempt Fast Track Designation (FTD) in the US with only animal data. However, human data is required for other programs.
For an IND, you typically need GMP batches, validated analytical methods, viral safety tests, and sufficient stability data to support storage, transportation, and in-use conditions. You also need comprehensive pharmacokinetic and toxicity data in both rodent and non-rodent models. For IITs, the requirements are simpler: you only need one GMP-like batch release and preliminary nonclinical safety data in rodents for a successful submission.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
CMC manufacturing & testing
Our experienced RA team provides comprehensive regulatory filing support, offering guidance from preclinical stages to commercialization.
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Ask the Experts
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
