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Contract manufacturing for recombinant enzymes and proteins

Contract manufacturing for recombinant enzymes and proteins

Contract manufacturing for recombinant enzymes and proteins

Your proprietary protein, a catalog enzyme in bulk, or a newly designed variant. Made in one CLīM™ purification step, in an ISO 13485-compliant system, from 10 mg to more than 100 g.

Your proprietary protein, a catalog enzyme in bulk, or a newly designed variant. Made in one CLīM™ purification step, in an ISO 13485-compliant system, from 10 mg to more than 100 g.

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Manufacturing

What we manufacture

Your proprietary protein

We add your sequence to a CLīM™ vector and develop a production protocol, so you can stop making it in-house.

Catalog enzymes in bulk

Gram-scale lots of enzymes we already make, with your formulation, packaging and lot-specific QC.

AI-designed variants

Designed proteins produced and purified fast, on a process that scales once a candidate is chosen.

Three ways to work with us

Start where your project is today; each model leads into the next.

Start here

Pilot2Partnership™

A no-cost pilot lot made to agreed specs, with a full QC package, for projects headed to bulk or recurring supply.

Milestone-based

Development program

Phased work on a new or difficult protein: expression, purification, activity and stability, with a go/no-go at each phase.

Recurring

Supply agreement

Forecast-based lots on a locked process, with CoAs, agreed lead times and continuity planning.

From sequence to supply

1

Sequence review

Feasibility and fit with CLīM™.

2

CLīM™ adaptation

Construct design and expression.

3

Pilot lot

Made to agreed specs, with QC data.

4

QC alignment

Tests matched to your assays.

5

Scale-up

Same process, larger lots.

6

Recurring supply

Lots on your forecast, with CoAs.

Capabilities

What sourcing and CMC teams ask first

Scale

10 mg pilot to >100 g lots

Purity

≥95–99% from one-step affinity purification

QC methods

Enzymatic activity assays, HPLC-SEC, protein quantitation

Formats

Custom formulation and packaging

Development add-ons

Protein engineering, solubility screening

Documentation

Lot-specific CoA; full QC data package at pilot

Quality

Built to be qualified as a supplier.

ISO 13485-compliant production for research- and diagnostic-grade proteins.
  • Batch-to-batch consistency on a locked process

  • Lot traceability and change control

  • Supplier questionnaires and customer audits supported

  • U.S. manufacturing in Birmingham, Alabama

Questions sourcing teams ask

Who owns the IP in my sequence and process?

What are typical lead times for a pilot and for a production lot?

Is there a minimum order?

How do you handle supply continuity?

Tell us about your protein.

Qualifying projects get a free pilot lot through Pilot2Partnership™.