Examples of Consulting Services at Belmark CMC
Here are a few case studies that showcase the type of support provided to clients. Your programmes will face their own specific challenges. Belmark CMC can bring its broad experience and depth of technical proficiency to deliver the types of outcomes highlighted in the examples below.

Case Study 1:
Recombinant protein: process development and GMP production

A European based, small biotech company developing a recombinant protein for an orphan disease was looking to transition their lead candidate to first in human clinical trials. Support included: contractual negotiations with contract manufacturers (CMOs); management of CMOs through expression system development, manufacture of MCB, analytical and process development, formulation development, GMP manufacture of drug substance and drug product, and stability studies; writing of IMPD. The outcome was the successful supply of clinical grade product, according to the planned timelines and a submission-ready IMPD.

Case Study 2:
Antibody: outsourced large-scale GMP manufacture

A European based biotech company wanted to develop novel antibodies to treat inflammatory diseases and infectious diseases. Support included: screening of potential CMOs and contract negotiations; overseeing process development and tech transfer; scale-up to large-scale GMP manufacture; sourcing of contract partners for novel formulation development; acting as head of manufacturing/CMC; taking a lead on joint steering committee with CMO; developing cost of goods model; supporting due diligence defence during financing; CMC regulatory strategy. The outcome was a manufacturing process proven at large scale leading to GMP production of clinical material.

Case Study 3:
Due diligence in support of licensing and acquisitions

A number of companies have reached out for support on due diligence exercises that included an element of manufacturing. In one case, the client was looking to acquire a small biotech holding license to a marketed, biologic drug. Support included: on-site inspection of the manufacturing facilities; interrogation of documents in the data room; interviews of site staff; writing of due diligence report. The outcome was an acquisition by the client. In another case, the client was looking at the option to license a marketed biologic drug for evaluation in an additional indication. Support included review of documents in the data room; interviews of the licensee’s technical team (US-based); writing of due diligence report and preparation of slide presentation for Board review.

Case Study 4:
Tech transfer of food supplements portfolio to CMOs

A large pharma company was looking to transfer a wide ranging portfolio of marketed consumer health products, some medicinal and some food supplements, from in-house GMP manufacture to third party contract manufacturers. Support included: technical leader for tech transfer team, overseeing product risk analysis and transfer planning; joint quality leader, managing analytical validations and transfers, and executing a large number of stability studies; on-site support at sending site and receiving sites; provision and oversight of additional technical/quality resources deployed to the project. The support resulted in successful establishment of GMP operations at the CMOs and valuable data for decision-making on commercial viability of products within the portfolio.

Case Study 5:
Peptide: early phase manufacture, supply and formulation

A single asset development company was looking to establish a virtual development team to achieve proof of concept for a novel synthetic peptide. Support included: managing secondary manufacturing of clinical IMP at CMO; arranging GMP audits of CMOs; co-ordinating clinical supplies for Phase 2 studies; selecting formulation development partner and overseeing development of an optimised formulation; technical and quality management of long-term stability studies; writing of CMC sections of Investigators’ Brochure and IMPD. As a result, several clinical studies have been completed.