Plasmid Manufacturing

Plasmid Manufacturing
Filtering clarified bacterial lysate

Andelyn Biosciences has more than 20 years of experience in plasmid manufacturing, and we possess the capability and capacity to manufacture batches of plasmids in any size depending on client specifications – from small trials to clinical-scale plasmid production.

In all of our manufacturing, we emphasize GMP compliance, and follow best practices for plasmid upstream production and downstream purification development, as well as material segregation, large-scale fermentation, and much more.

All products are created with full traceability and document control to ensure they meet customer specifications – and with rigorous quality control testing, we ensure our customers only get high-grade plasmids that will meet their specific needs.

 

Plasmid Production Core

Our plasmid production core uses state-of-the-art tools and technology that allows you to rapidly scale plasmid manufacturing, providing you with shorter overall lead times and more flexibility in manufacturing timelines. We can accommodate changes in schedule and scale easily, ensuring your project goes off without a hitch. 

The Plasmid Production Core facility comprises of laboratory space reserved for plasmid manufacturing for research grade productions and for IND-enabling toxicology productions along with AAV vector cloning capabilities.

Plasmid production scales can range from small scale 5-25mg preps up to large scale 100-500mg preps. Scales are determined by the amount of bacteria (liters) grown. For large-scale preps, the amount is determined in increments of 12L.

Critical materials used for Plasmid Production Core are single-use, disposable and are defined and specified prior to production. Materials used conform to USP/NF guidelines where appropriate. All materials used are recorded in solution preparation forms or on plasmid batch records.

Toxicology Grade Plasmids

QC Release Testing
Test Name Test Description Acceptance Criteria
Endotoxin Kinetic Chromogenic (USP/FDA I/E Assay) <100EU/mL
Concentration UV spectrophotometry Custom to each product
DNA Homogeneity Densitometry analysis of ethidium bromide stained agarose gel >80% Supercoiled
Identity Ethidium Bromide stained agarose gel electrophoresis Co-migrates with client reference standard or size confirmed with a supercoiled marker
Purity 260/280 absorbance ratio 1.8-2.0
Restriction Digest Ethidium Bromide stained agarose gel electrophoresis Matches expected restriction pattern or client supplied reference material
Sequencing - PacBio: Vector Plasmids
- Sanger: Capsid Plasmids
Identical to client supplied reference sequence

Research Grade Plasmids

Release Testing
Concentration UV spectrophotometry Custom to each product
DNA Homogeneity Densitometry analysis of ethidium bromide stained agarose gel >75% Supercoiled
Identity Ethidium Bromide stained agarose gel electrophoresis Co-migrates with client reference standard or size confirmed with a supercoiled marker
Purity 260/280 absorbance ratio 1.8-2.0
Restriction Digest Ethidium Bromide stained agarose gel electrophoresis Matches expected restriction pattern or client supplied reference material

Plasmid Manufacturing Services

We offer full-scale plasmid manufacturing services for gene therapy, and our reliable, high-quality products ensure the success of our partners.

Whether you need to manufacture an existing proprietary plasmid that you have already developed, or you need to develop a new custom plasmid according to a specific set of specifications, Andelyn Biosciences will work with your team every step of the way. We offer both upstream and downstream process development support – and comprehensive fill/finish capabilities to streamline the process of manufacturing your plasmids.

We can scale our services depending on your needs – from small-scale 5-25mg preps for initial testing and research to 100-500mg preps. Plasmid manufacturing scale will be determined by the amount of bacteria (in liters) grown for production, and large-scale preps are measured in increments of 12 liters. 

Why Choose Andelyn Biosciences? Our Expertise & Dedication To Quality

At Andelyn Biosciences, our stellar track record, end-to-end approach plasmid development and manufacturing, and dedication to product quality and reliability make us the best choice for plasmid production.

From small test batches to large-scale, plasmid manufacturing, we can handle projects of all sizes, complexities, and requirements. To learn more and get started, contact us online to speak to one of our experts and discuss your unique needs in further detail.