Pioneering Partners in Gene Therapy Pharmaceuticals Innovation.
Our Mission Catalyzing Global Well-being through the Transformative Potential of Nucleic Acid Drugs!
Guangdong Veliter Biomedical Technology Co., Ltd, founded in July 2019, led by experts with specialized knowledge unique to oligonucleotide process development and manufacturing, tens of years of experience in pre-clinical and clinical development of innovative oligo drug products, come from globally recognized pharmaceutical enterprises and CDMO firms, specializes in phase appropriate analytical method development/validation, process development/validation, scale-up, non-GMP and GMP manufacturing, formulation, and CMC/regulatory solutions/services.
Our product portfolio encompasses Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), Phosphorodiamidate morpholino oligonucleotides (PMO), and Peptide-conjugated phosphorodiamidate morpholino oligonucleotides (PPMO) which diversify into ASO, siRNA, miRNA, Aptamer, circleRNA, CpG ODN, sgRNA, among others.
Leading AD/PD lab and manufacturing facilities
Dongguan Location
Located in Songshanhu Park, Dongguan City, Guangdong Province, features leading Analytical Development, Process Development, and Quality Control laboratories. At our GMP factory, the combined production capacity of both non-GMP and GMP lines stands at 15-20 kilograms per year.
Meanwhile, the non-GMP production line at our VPS manufacturing facility in Dongguan Songshanhu Park is set to achieve an annual capacity of 3.2 kilograms.
Changsha Location
Expansion of our state-of-the-art development laboratories and manufacturing facility is currently underway to meet the increasing demands of our customers in Changsha, Hunan. The construction of Scale batch 1.5 mol asset is in progress and is expected to reach a large-scale production capacity of 120-150 kilograms per year. Contact usMeet the core team ofoligo experts
Alex Xu | CEO & Founder
Alex Xu, with his extensive background in small molecule drugs and oligonucleotides, has significantly contributed to the field since 2007. His roles have included Senior Scientist and Project Leader at Ariad Pharm. Inc., Qiagen, and Nitto Avecia Inc.
Since July 2019, Alex returned to China from Boston to establish Shenzhen Veliter Biotechnology Co., Ltd, Guangdong Veliter Biomedical Technology Co., Ltd, and Hunan Veliter Biomedical Technology Co., Ltd respectively.
Alex and his leadership aim to foster gamechanging nucleic acid drug therapies through strategic partnerships with global gene therapy innovators.
Andrew Xu | Deputy General Manager Production Manufacturing Center
Andrew Xu brings over 20 years of experience in drug development and production from renowned institutions and companies, including Harvard Medical School and AstraZeneca, as well as WuXi AppTec Group and WuXi Biologics.
At Veliter, Andrew oversees the management of Veliter’s GMP factory production.
Mr. John Sui | Partner/CSO/CMC analytical/Regulatory affairs
Mr. Sui is a powerhouse innovator with 16+ years of experience in CMC drug development (pre-clinical to ph3) and commercial product management
Mr. Sui’s expertise ranges across analytical development & QC, validation for both API and DP, innovative control strategy development, GxP practice, and regulatory, filing authorship & review experiences (IND/IMPD/NDA/MAA/briefing books in US, Europe, Asia, LATAM)
Notable achievements include:
- Extensive collaboration with 20+ CRO/CMOs across Europe, USA, and Asia.
- Led development efforts of Patisiran/Tofersen and other oligonucleotide products. Hands-on involvement from clinical, CMC, regulatory, and registration to commercialization.
- Has held senior-level positions in top pharmaceutical drug development firms:
- Director/CMC Analysis, Kymera Therapeutics (since 2022)
- Deputy Director/Commercial QA/QC, Akcea Therapeutics/Ionis Pharmaceuticals (2020-2022)
- Senior Scientist/CMC Analytical, Biogen Pharmaceuticals (2018-2020)
- Senior Scientist/CMC Analysis, Alnylam Pharmaceuticals (2015-2018)
- Senior Scientist/CMC Analysis, Vertex Pharmaceuticals (2010-2015)
A reliable and scalable processto ensure oligonucleotide quality and compliance
To ensure quality and compliance throughout the entire oligonucleotide manufacturing process is critical to oligo DS/DP projects. At Veliter, our Quality Management encompasses the whole development to give you confidence in your outsourced oligo program.
Comprehensive Quality Management
Veliter Quality management encompasses QA, Regulatory support, and Validation. Our customer-approved facilities produce API, adjuvants, and intermediates that meet the NMPA, FDA, EMA and other regulations, and relevant cGMP requirements of 21 CFR Part 210 and 211 and/or other regulations, and ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. A dedicated QA representative will review and meet all applicable regulatory, quality standards and requirements throughout your project.
Client Audit Record
Proactive approaches were taken to meet quality and regulatory excellence of client’s outsourced oligonucleotide programs at Veliter, currently 2 to 3 client-approved audits are undergoing annually.
Regulatory Compliance
Our QA department works with all Veliter departments to meet applicable U.S. regulations and ICH guidelines, including:
Current Good Manufacturing Practices (cGMP) per USFDA 21 CFR Parts 210 and 211
ICH Guidelines:
- Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients (API)
- Q8 Pharmaceutical Development
- Q9 Quality Risk Management
- Q10 Pharmaceutical Quality System
- Q11 Development and Manufacture of Drug Substance
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
As a global oligonucleotide manufacturing solutions CDMO, we work with you to accommodate your region-specific Quality and Regulatory requirements.
Innovative Oligonucleotide Manufacturing
QbD(Quality by Design) and DoE(Design of Experiments) will be applied to examine every parameters of the manufacturing process to reach a optimized process that represents a step change improvement in oligonucleotides process development and manufacture. Innovative and dedicated process from Veliter will allow for high-volume, high-throughput production while maintaining the high quality and value to meet your expectation.
New manufacturing platform technologies
Compared with conventional oligonucleotide manufacturing process Veliter is developing a new platform-combined synthesizer, alternative purification and separation technologies resulting in higher throughput and product yields making production more scalable.
More greener manufacturing
Elimination of excess of phosphoramidites and large volumes of solvents required in synthesizing oligonucleotides and recovery of ACN from purification waste onsite in Veliter have reduced material costs and impact on the environment.
Technical specialties and products/services at Veliter
- Specific process route and equipment making single coupling efficiency NLT 99%
- Best-view technical platform
- On/off column conjugation platform (PEG and GalNAc etc.)
- Analytical/Process development and manufacturing platform for sgRNA
- Quality control of oligo impurities
- Oligo formulation development and manufacturing
- Oligo CMC/regulatory affairs(work experience with Patisiran/Tofersen/Inclisiran/Zilebsiran etc.)
- Various oligo products such as DNA, RNA, PMO and PPMO which diversified into ASO, siRNA, miRNA, Aptamer, circleRNA, CpG ODN, sgRNA etc., from lab to commercial。
Technical specialties and products/services at Veliter
- Specific process route and equipment making single coupling efficiency NLT 99%
- Best-view technical platform
- On/off column conjugation platform (PEG and GalNAc etc.)
- Analytical/Process development and manufacturing platform for sgRNA
- Quality control of oligo impurities
- Oligo formulation development and manufacturing
- Oligo CMC/regulatory affairs(work experience with Patisiran/Tofersen/Inclisiran/Zilebsiran etc.)
- Various oligo products such as DNA, RNA, PMO and PPMO which diversified into ASO, siRNA, miRNA, Aptamer, circleRNA, CpG ODN, sgRNA etc., from lab to commercial。
Positive oligo program experience, from end to end
Focusing on your needs and building long-term partnerships, your own Veliter’s project manager will be flexible and responsive. This is Veliter’s approach to make your oligonucleotide program move smoothly through pre-clinical to commercial.
Dedicated Project Management
Our project managers are customer focused, tailored for your oligonucleotide projects and report directly to the VP of Business Development and Project Management. All project managers have technical backgrounds on oligonucleotide at Veliter.
Intention:
Project needs analysis:
Proposal:
Agreements:
Project Execution:
Change scope:
