Some of the projects we have recently undertaken:
- Provision of CMC support for a UK biotech company developing a novel treatment for cancer. Ensured availability of IMP for phase I and Phase II clinical studies, transferred manufacture from UK to mainland Europe, wrote the IMPD. Represented the client at meetings with the MHRA and FDA.
- Provision of CMC support for an organisation developing a peptide/adjuvant mixture, for the treatment of cancer. Ensured that assays, stability studies and trial batches were sufficiently well-developed to support a clinical trial application. Wrote the IMPD. Provided QP services for certification of drug product batches.
- Provision of CMC support for a company developing a nanomedicine consisting of an oligonucleotide plus a carrier, for the treatment of cancer. Wrote the briefing document and arranged the provision of scientific advice from a European health authority.
- CMC support for a US company developing a dendritic cell treatment for glioblastoma. Managed the transfer of manufacture to a UK facility and reviewed and revised the IMPD which led to a successful Clinical Trial Application.
- Provision of GMP advice for a new £200m antibiotic facility in China. Wrote high-level validation documentation and reviewed validation protocols.
- Provision of interim quality management services for a Japanese biotech company. Responsible for all aspects of CMC for a drug-device combination. Led to successful clinical trial applications in US (Phase I) and EU (Phase III). Represented the client at meetings with the DEA and FDA
- On-site visits and review of development plans for a pharmaceutical manufacturer in Australia.
- Provision of interim quality management services for a UK biotech company developing a new oral solid dose anti-malarial product. Managed the outsourced activities, including assay and process development and the manufacture of the IMP. Wrote the IMPD, which resulted in a successful CTA approval.
- Quality reviews, design reviews, risk analyses and audits carried out worldwide, including analytical laboratories and manufacturing sites for API’s, finished products and clinical trial materials. Audit standards cover cGMP, GLP and GCP.
- Development and delivery of GMP and risk management training courses. Highly rated by attendees. Courses delivered in UK, mainland Europe and China.
- Provision of CMC support to an academic facility developing a gene therapy product. Resulted in successful regulatory inspections. Provision of QP services for drug product certification.
- Carry out GMP audits and provide QP certification advice to a US company carrying out a multi-centre phase III study in Europe, on an oral solid dose kinase inhibitor.
- Benchmarking the efficiency of a global pharmaceutical company’s manufacturing operations and identification of improvement opportunities.