Takara Bio

Manufacturing

Manufacturing support from research to controlled execution

Bring your process to our manufacturing teams for scale-up, transfer and documented production support, keeping performance stable as volumes grow.

What this covers

How manufacturing support works with us

  • Process transfer and scale-up planning
  • Documented production with per-lot release testing
  • Change control and stability programmes
Scale-upProcess transferRelease testingStability studies

At a glance

Scale
Pilot through commercial volumes
Quality system
ISO 9001; GMP options available
Testing
Identity, purity, activity, stability
Documentation
Batch records, CoA, deviation reporting

Service flow

  1. 1Assess the process
  2. 2Plan the transfer
  3. 3Engineering lots
  4. 4Routine production

Process

A clear path from enquiry to delivery

  1. Step 01

    Assess the process

    Review current method, materials and constraints.

  2. Step 02

    Plan the transfer

    Define specification, testing and acceptance criteria.

  3. Step 03

    Engineering lots

    Confirm the scaled process performs as expected.

  4. Step 04

    Routine production

    Scheduled lots with full documentation.

Good to know

Manufacturing support engagements begin with a confidential technical review.

Talk to us

Tell us what you need and we will scope it with you

Share the essentials and a specialist from the relevant team will respond with next steps, feasibility and indicative timing.

Discuss manufacturing support

We can sign an NDA before detailed process discussion.

Support

Not sure which service fits your project?

Our scientists can help you choose between custom development, formatting and manufacturing support.