The Ohio Clinical Trials Collaborative and Bryla CMC-Reg Consulting have entered into a co-marketing agreement to leverage the synergies of the two organizations in delivery of services to industry. The OCTC will provide integrated research, clinical trial and core lab services, while Bryla CMC-Reg Consulting will offer commercialization services in chemistry, manufacturing and control, known as “CMC”.
BrylaCMC-Reg Consulting services provide a full-range of CMC services: all aspects of formulation, aseptic and non-aseptic manufacturing processes and analytical development, technology transfer, process scale up, phase-appropriate validation, supply chain management, regulatory development of specifications, dating period, impurity limits and starting materials, stability trending, quality system, preparation of CMC module 2/3 electronic regulatory submissions following recent ICH/FDA guidelines, QbD and QbR platforms and liaison services with regulatory authorities.
Drug Substance and Drug Product Expertise:
- CMC and CMC Regulatory Affair Gap Analysis
- Product Commercial Launch Preparation (Non-Aseptic and Aseptic Processes)
- CMC Project and Outsourcing Management, and Quality System (QS)
- Global Product Development & Operations
- Formulation Development
- Formulation Prototype PK Studies in Animals, In Vitro – In Vivo Correlations
- Aseptic Manufacturing of Monoclonal Antibody BDS, Drug Product Fill-Finish, BFS Filling, and Media
- Fill Runs; Protein Characterization, Comparability Studies
- Clinical and Commercial CRT and Cold Chain Supply Management
- CMC Regulatory Affair
- Impurity Qualification, Genotoxic Impurities Assessment, Clinical and Commercial Specifications
- Analytical Methods Development, Validation and Transfer Appropriate to Developmental Phase
About Piotr Bryla, Ph.D.,
Piotr Bryla, Ph.D., President of Bryla CMC-Reg-Consulting, LLC and Worldwide Who’s Who member, is a seasoned professional expert in directing clinical and commercial CMC Development and Operations for global pharmaceutical companies, as well as worldwide external manufacturing and research organizations. He has a proven track record of delivering results which ensures rapid, risk-reduced and cost efficient progression of clinical candidates (small, semisynthetic and monoclonal antibody therapeutics) through development and commercialization processes; solid CMC technical and regulatory knowledge of small molecular weight and biological (protein) products; record of launching drug products in the US market; worked for major corporations, small start-up biotech companies, and directed CMOs/CROs worldwide. Recognized as strategic leader with demonstrated expertise in situational leadership.
Dr. Bryla has a quarter century of industry experience and expertise in directing clinical CMC development and operations. His company provides expertise in global CMC regulatory affairs for active pharmaceutical ingredients and drug products from discovery through all clinical phases and to commercial launch. Product experience spans small molecular weight therapeutics, semisynthetic drugs, and monoclonal antibody therapeutics.
His expertise encompasses discovery, preformulation, formulation, analytical and manufacturing process development, clinical supply chain management, and preparation of CMC modules for clinical and marketing dossier applications.