Welcome
Biotech CMC consultant advice for protein biologics
We will map out a phase appropriate development plan and work with your CDMO to manufacture GMP material for clinical trials.
About DJH Biotech Consulting
Our Company
Dallas Hartman Ph.D. is the founder and Principal Consultant at DJH Biotech Consulting. Dallas has over 25 years experience in biotech where he has worked for large (CSL), medium (Nexvet) and small (AdAlta) companies, primarily on monoclonal antibodies, bispecifics, Fc fusion proteins and recombinant vaccines. Dallas has overseen the development of numerous protein therapeutics into clinical trials and commercial use. He has substantial experience in all aspects of biologic CMC, with particular strengths in analytics.
Our Mission
At DJH Biotech Consulting our mission is to help emerging biotech companies navigate the pathway from proof-of-concept animal studies to first-in-human clinical trials in a cost effective and efficient manner. We put the jigsaw pieces correctly into place first time, every time.
Our Services
We are an Australian based company that offers a consulting service on the development and manufacture of protein biologics for clients in Europe, USA and Asia Pacific. Specifically, we have extensive experience advising on cell line development, bioprocess development, analytic assay development and validation, formulation development, manufacturing of drug substance and drug product, stability studies, physicochemical characterisation studies, selection and management of CDMOs, drafting of CMC regulatory documents, and overall CMC strategy. We can put all the pieces together to push your program in the right direction.
Our Approach
At DJH Biotech Consulting we understand that funds are scarce for small startups and every dollar spent must add tangible value. We work with clients to identify the most efficient and cost effective phase appropriate CMC strategy.
Consulting Services offered by DJH Biotech Consulting
Selection and management of CDMOs
DJH Biotech Consulting has worked with many world leading CDMOs on the development and manufacture of investigational protein therapeutics for our clients. We work with clients to identify their development needs, align these with the offerings of appropriate CDMO service providers, and oversee the entire selection process. We thoroughly interrogate and appraise CDMO proposals, recommend improvements, and negotiate costings. Once the CDMO is selected, we provide scientific, technical and project management oversight to ensure all deliverables are met in a timely manner and at a phase appropriate level.
Technical CMC advice
DJH Biotech Consulting provides technical advice on all aspects of product development for protein biologics. Whether it be cell line development, analytical assay development, formulation development, upstream or downstream processing, stability studies, or physicochemical characterisation, we have extensive experience and knowledge we are eager to share.
Manufacturing oversight
DJH Biotech Consulting will oversee your precious toxicology and clinal manufacturing batches. We will act as your person-in-plant for these critical manufactruing operations.
Drafting of product development plans and CMC documents for regulatory purposes
DJH Biotech Consulting can draft extensive product development plans and CMC documents to support your regulatory filings.
Contact Us
Better yet, talk to us in person!
We love our clients, so feel free to call during normal business hours +61 499110295.
Hours
Open today | 09:00 a.m. – 05:00 p.m. |
