Your CMC function, without the headcount.
Senior technical leadership from candidate selection through IND, so early decisions do not become late problems.
Genetic medicine · Discovery through lifecycle management
Genetic medicine consulting,from discovery to lifecycle management.
VectorSim LLC works with startups, clinical-stage and commercial companies, CDMOs, and CROs on AAV, siRNA, and bioconjugate programs. Hands-on support from candidate selection through process development, GMP manufacturing, PPQ, and BLA submission.
ModalitiesAAV gene therapysiRNA & oligonucleotidesBioconjugates
U.S. FDA · Platform Technology Designation
Our team supported the process and CMC work behind a U.S. FDA Platform Technology Designation granted to a viral vector platform, and we bring that experience to designation requests, briefing books, and platform strategy for new programs.
Services, in the order your program moves
Support at every stage, from first candidate to approved product.
Step in wherever your program is: we lead, augment your team, or deliver a scoped workstream.
Stage 01
Discovery
Target → lead candidate → proof of concept
Find the right candidate and prove it works.
We help teams move from a target to a defensible lead across AAV, siRNA, and bioconjugate programs: shaping candidate and modality strategy, assessing developability early, and navigating CROs and CDMOs to generate proof-of-concept material without losing months.
- Target & candidate strategy
- Modality & conjugate strategyAAV, siRNA, and bioconjugates
- Proof-of-concept material generation
- CRO / CDMO selection & navigation
- Early developability & CMC risk assessment
- Discovery-to-development roadmaps
Stage 02
Process Development
Preclinical → IND-enabling
Build a platform process you can scale and defend.
Upstream, downstream, and analytical development designed as a platform from the start, with the risk analysis, scale-down models, and phase-appropriate quality systems needed to support an IND and the campaigns that follow.
- Upstream & downstream process development
- Analytical development & method qualification
- Platform process design & scale-down models
- FMEA & process risk assessment
- IND supportCMC / Module 3 authoring and review
- Phase-appropriate quality systems & SOPs
Stage 03
Clinical Manufacturing
Technology transfer → GMP clinical supply
Get GMP material made, on time, with the right partner.
We navigate and manage CDMOs and CROs for GMP material production, lead technology transfer, review the batch records, and put QC and data analysis in place so every batch is understood before it is released.
- CDMO / CRO qualification, oversight & quality agreements
- GMP material production
- Technology transferLab → clinical → commercial scale
- Batch record review & manufacturing readiness
- QC strategy, method transfer & release testing
- Deviations, OOS / OOT investigations & CAPA
Stage 04
Validation & Regulatory
PPQ → BLA → approval
Prove control, then file.
From process performance qualification through BLA submission, with FDA meeting strategy and briefing books that get the right questions answered. We write the CMC sections, prepare the team for the meeting, and manage the responses that follow.
- PPQ strategy & execution
- Process validation & IQ / OQ / PQ
- CMC authoring for BLA / MAA
- FDA meetings & briefing booksType A, B, and C
- Platform Technology Designation requests
- Information request & inspection responses
Stage 05
Commercial & Lifecycle Management
Commercial → post-approval → next generation
Keep improving after approval.
Post-approval changes, comparability, continuous process verification, and second-generation processes handled with the same rigor as the original filing, plus the Six Sigma tools to make improvement measurable.
- Post-approval changes & comparability
- Continuous process verification & trending
- Annual product quality reviews
- Six Sigma process improvement
- Second-source & CDMO-to-CDMO transfers
- Platform expansion to new programs
Who we work with
Startups to commercial companies, sponsors and partners alike.
A three-person virtual biotech and a commercial manufacturer need different things from us, and we scope accordingly.
Specialist capacity for the workstream that matters now.
A tech transfer, a PPQ campaign, a BLA module, an FDA meeting: defined scope, senior hands, clean handoff.
Client-side expertise that speaks your language.
We help partners scope, execute, and de-risk programs for their customers, and we help sponsors get the most out of their partners.
How we engage
Direct, stage-appropriate, execution-minded.
01
Focused advisory
Resolve a defined technical question, decision, or program risk in days, not quarters.
02
Embedded leadership
Add experienced discovery or CMC capacity to your team through a critical development phase.
03
Project delivery
Scope and execute a specific workstream with clear deliverables: a briefing book, a qualified scale-down model, a tech transfer package.
About VectorSim LLC
Built by people who have taken genetic medicines from bench to BLA.
VectorSim LLC was founded by Nermin Ibreljic, Founder and Managing Member, who spent his industry career as a process engineer in gene therapy manufacturing, most recently as a Principal Engineer, with hands-on experience in process development, scale-up, technology transfer, and CMC on AAV programs from early development through commercial manufacturing.
We bridge industrial bioprocess engineering and graduate-level biotechnology teaching, and we bring Six Sigma Black Belt discipline to the data. Our mission is to compress the time between a promising candidate and an approved medicine, so the next generation of genetic medicines reaches patients faster.
Credentials
- Founder
- Nermin Ibreljic, Founder and Managing Member
- Industry
- Principal-level process engineering in gene therapy (AAV) manufacturing, lab scale through 2,000 L
- Regulatory
- Team experience behind a U.S. FDA Platform Technology Designation for a viral vector platform; IND and BLA CMC authoring
- Academia
- Northeastern University (graduate biotechnology faculty) · University of Massachusetts Lowell
- Methods
- Six Sigma Black Belt · FMEA · DoE · Scale-down model qualification
- Modalities
- AAV · siRNA & oligonucleotides · Bioconjugates
Start with the immediate challenge
Tell us where your program is.
Share the modality, the stage, and the decision in front of your team. We will tell you honestly whether and how we can help, usually within a business day.