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Compass Biotechnology’s typical client is a small to medium size biotech firm who either may be new to working with contract manufacturing organizations, or may have had trouble in the past in working with CMOs, and would like to improve upon their experiences in this regard.

Compass likes to become part of your team moving forward, representing you to the contract manufacturing world. In doing so, Compass can assist in working with a CMO on a variety of different levels, from properly finalizing process development work, to orchestrating contract negotiations with a chosen CMO, to full management through all phases of manufacturing operations.

As you consider carrying out your contract manufacturing work, Compass will:

  • carefully assess all of your process development and manufacturing information;
  • produce an RFP for presentation to various CMOs;
  • in conjunction with an RFP, generate a GAP (risk) analysis with regard to your existing data package. If additional process development work is deemed necessary, then Compass is capable of assisting with this as well.

Once the process development work is deemed complete, Compass will then:

  • present you with a summary and recommendation of roughly 4-6 CMOs that could adequately carry out your particular manufacturing work;
  • a cost/benefit analysis about each CMO;
  • present you with examples of a few different CMO contracts, similar to what we have negotiated for other clients in the past;
  • work closely with you in negotiations with the CMO;

After a CMO is selected and a contract is finalized and executed, we will work with you on implementation, which could include management during all the major phases of the project, including
i) tech transfer, ii) manufacturing, and iii) regulatory/CMC work.

As part of your team, Compass provides full-service CMO contract negotiation and production services, from assessment, to RFP generation, to CMO evaluation and recommendation, to contract construction and negotiation, to implementation (contracting, project management, tech transfer, manufacturing oversight, and CMC regulatory submissions) and maintenance. However, we are fine in helping our clients with only a single phase of the process, should you so desire