Advanced Solutions for mRNA Synthesis and Biotechnology
mRNA Synthesis
State-of-the-art facilities for precision mRNA production
Research & Development
Cutting-edge biotechnology research capabilities
Manufacturing Excellence
Advanced production solutions for biotechnology applications
Lindholt Bio -m Workflow Overview
Our integrated partnership workflow ensures quality and efficiency in mRNA enzyme production and delivery:
Manufacturers
Globally
Source and provide high-quality raw materials and enzymes as input for our production chain
MN Bio
India
Specialized data generation, initial quality testing for Lindholt Bio products. Customer projects for North X.
Lindholt Bio
Lund, Sweden
Core quality assurance, data validation, and documentation management
NorthX
Matfors, Sweden
Professional bottling, storage, and shipping operations under Lindholt Bio branding
NorthX Bio & MN Bio
Long term business relationship with MN Bio, channeled through Lindholt on mRNA
MN Bio will relay customer projects
NorthX will demonstrate capability in the mRNA field, starting with generating data on Luciferase and OVA. Lindholt with through MN Bio provide with raw materials and sequence
Lindholt need to propose a practical way of working with NorthX regarding receiving bulk chemicals (all 8 of them), filling vials and making them ready for shipment.
Lindholt needs to propose a way of working with documentation. Some data will be generated by Nanghavi (which) and some at North X. What is the timeline of generating application data at MN ?
NorthX Bio & Lindholt Bio
Lindholt proposes a practical way of working with NorthX regarding
receiving bulk chemicals (all 8 of them),
filling vials and
making them ready for shipment.
documentation. Some data will be generated by MN Bio & Nanghavi (which?) and some at North X. What is the timeline of generating application data at MN?
Data Generation & Bottling
Key Questions for Workflow Implementation
Data Generation in India (MN Bio):
What data is required for documentation and regulatory compliance?
How long does data generation and validation take?
Bottling at NorthX:
What form: Liquid or powder?
Volume per batch?
Required freezing capacity: How much storage at -18°C is available or needed?
Shipping & Storage Considerations
Key Logistics Challenges
Shipping Requirements:
Shipper type for -18°C transport (high costs due to freezing requirements).
Estimate: Number of samples expected to be sent in the coming months.
Bulk to Sample Protocols:
Standardized processes for breaking down bulk into samples.
QA documentation: Use data generated by MN Bio or new data by NorthX?
Documentation & Branding
Ensuring Consistency & Compliance
Documentation Ownership:
Should Lindholt use MN Bio's data for regulatory documentation?
Or generate new data/documentation through NorthX?
Branding:
Products branded under Lindholt Bio with complete QA documentation.
Potential need for Lindholt to rent an address at NorthX for better coordination.
Target Customers & Strategy
Exploring Opportunities in the mRNA Market
Potential Customers:
Blue Moon: Evaluate needs and supply chain requirements.
OEM Customers: Bulk chemicals with minimal branding/documentation.
Univercell: Offers strong automation in mRNA generation; explore collaboration.
Academic Outreach:
Engage Swedish academics with sample products to gather valuable feedback and data.
Clinical Pipeline Opportunities:
Research which mRNA products are entering clinical trials.
Assess Lindholt’s ability to deliver enzymes/chemicals for those studies.
Next Steps & Open Questions
Decisions and Action Items
Finalize data requirements for MN Bio and NorthX.
Determine bottling process and scale (liquid vs powder, volumes).
Assess shipping logistics for -18°C transport.
Plan outreach to target customers, including academics and clinical trial providers.
Decide on renting an address at NorthX for logistical efficiency.
Standardize documentation process to ensure compliance and QA consistency.
Lindholt has published the product catalogue. Anything else needed for starting referring customers to Lindholt?
First products to be shipped to North X end of Jan (up date on time please)