Expert guidance for biologics manufacture and compliance
Specialized consulting services to biotech and pharmaceutical companies, ensuring excellence in biologics manufacturing
Helping organizations improve and standardize processes, address gaps in control strategies and alignment with current quality and regulatory guidelines
About Jurgen
I am an expert in development and manufacturing of protein therapeutics using cell substrates of human and animal origin, with years of experience working in biotech and pharmaceutical companies. Specialities are cell line development (i.e., CHO) and the compliance of processes with current regulatory guidelines for manufacture of highest quality safe biological products.
At BMS, I established appropriate controls to prevent viral contamination of manufacturing processes and facilities and ensured that internal procedures were aligned with current regulatory and quality guidance, e.g., ICH Q5A (R2), the main guideline for viral safety of cell substrates of human or animal origin. I implemented methods for genetic characterization of manufacturing cell banks and oversaw their tech transfer to a QC laboratory. In addition, I led the Process Analytics group, responsible for in-process testing of drug substance and support of PPQ campaigns.
At Novartis Vaccines, I established a “state of the art” CHO cell line development platform to generate manufacturing cell lines for viral subunit vaccines. I was responsible for all aspects of cell line development and characterization.
Prior to Novartis, at Dyax Corp., I developed technology for mammalian expression of fully human antibodies and led client-funded projects on antibody discovery and maturation.
I spent time as a postdoctoral Scientist in academia and at Immunex, and hold a PhD in Biology from RWTH Aachen in Germany.
Expertise and Services
Areas of Expertise
Specialties:
- Generation and characterization of cell substrates, e.g., CHO cell lines
- Manufacture, qualification and lifecycle management of manufacturing cell banks, e.g., WCB
- Safety and regulatory compliance of biologics, i.e., therapeutic protein manufacturing processes
- Viral Clearance and prevention of viral process and facility contaminations
Other areas of expertise:
- In-process analytics and drug substance characterization
- CMC strategy for manufacture of biologics, i.e., protein therapeutics
- Adaptation of biologics safety strategies to new modalities (ATMP)
Services (not limited to)
Cell Substrate Development:
- Guidance on generation of stable, highly productive cell lines using state of the art technology aligned with regulatory expectations
- Guidance on cell line characterization requirements prior to registrational filings
- Preparation of cell line development and history sections included in HA filings
CMC Strategy:
- Guidance on cell bank manufacture, characterization and qualification (MCB and WCB)
- Guidance on selection and validation of analytical test methods for cell substrate and drug substance characterization
- Develop strategies for demonstrating comparability of products following process changes
- Review and update of procedures to be aligned with current regulatory guidance (EP, USP, ICH), and standardizing CMC procedures across brands
- Contributing to quality risk assessments (QRA) and change control management
- Preparation of CMC sections for IND and BLA filings
Adventitious Agent/Virus Safety:
- Guidance on biosafety design of processes using cell substrates, especially the prevention of viral contamination by selection, testing and reduction (viral clearance)
- Assessment of virus, mycoplasma and TSE risk for biologics manufacture
- Evaluation of process and facility controls for prevention of a virus contamination
- Investigation of adventitious agent contaminations and implications of unexpected test results
- Viral safety design for ATMP, processes with limited viral clearance capabilities
Contact information
phone: +1 (857) 928 4657
email: mullbergj@gmail.com
Linkedin: linkedin.com/in/jmullberg