Strain development & optimization
High-throughput host and clone selection across our expression toolbox, codon and promoter engineering, and stability banking to lock in a manufacturable cell line.
Strain → Process → Scale
Microbial biologics, engineered to manufacture.
Tandemab Bio is a dedicated microbial fermentation CDMO. We take molecules from a single colony to commercial GMP supply — recombinant proteins, vaccines, plasmid DNA, peptides, enzymes and new molecular formats — with the process engineering rigor that gets you to launch on time.
EST. 1994
3 SITES / US & EU
5 L → 25,000 L
FDA · EMA INSPECTED
0+
Years in fermentation
0+
Programs delivered
0
Strains screened
0k L
Max GMP scale
Capabilities
One integrated team, from colony to commercial.
Microbial fermentation is unforgiving — titer, fold and purity are won at the bench and held at scale. Tandemab keeps strain engineering, process development and GMP manufacturing under one roof so nothing is lost in tech transfer.
Process development & scale-up
DoE-driven fed-batch optimization, scale-down models, refold development for inclusion bodies, and seamless transfer from pilot to commercial fermenters.
GMP drug substance manufacturing
Single-use and stainless fermentation suites with full downstream recovery, purification and bulk fill, supporting clinical through commercial supply.
Analytical development
Phase-appropriate method development, characterization, host-cell protein and residual DNA assays, and release testing aligned to ICH and compendial standards.
Formulation & fill
Liquid and lyophilized formulation development, aseptic vial and syringe fill-finish, and stability programs to deliver a finished, label-ready product.
Regulatory & CMC
CMC strategy, dossier authoring and BLA/MAA support, comparability and process validation — built into the program from day one, not bolted on at the end.
Expression systems
The right host for the molecule.
We screen across complementary microbial hosts to match expression level, post-translational needs and downstream economics — not the platform we happen to own.
E. coli
Bacterial / Gram-negative
Workhorse for high-titer recombinant proteins, peptides, scaffolds and plasmid DNA. Secreted, soluble and inclusion-body routes with refold.
P. pastoris
Methylotrophic yeast
Efficient secretion of correctly folded, disulfide-rich proteins at high cell density with simplified downstream purification.
B. subtilis
Bacterial / Gram-positive
GRAS secretion host of choice for enzymes and large secreted proteins, with low endotoxin burden and clean media.
Other microbial
Specialty hosts
Additional yeast and bacterial systems, including engineered strains for novel molecular formats and difficult-to-express targets.
Program lifecycle
A single path from pre-clinical to launch.
PHASE 00
Feasibility
Host selection, construct design and a go/no-go titer read in weeks.
PHASE 01
Process dev
Fed-batch and downstream optimization, scale-down qualification.
PHASE 02
Tech transfer
GMP readiness, batch records and analytical method transfer.
PHASE 03
Clinical GMP
Tox, Phase I–III drug substance and drug product supply.
PHASE 04
Commercial
Validation, BLA/CMC support and on-time commercial launch.
Let's build it
Bring us your hardest molecule.
Inclusion bodies that won't refold, a titer that won't lift, a timeline that won't move. That's the work we like. Tell us where you're stuck.