Quality Control and Analytical Sciences Consulting for small to mid-size Biopharmaceutical Companies
My range of experience and expertise can help your organization succeed. With over 2 decades in the biopharmaceutical industries my range of projects has included programs in gene therapy, biologics, peptides, vaccines, and combination pharm-devices. Over my 12 years in the immunodiagnostic industries I honed my expertise in the development of platforms including automated chemiluminescent, light scattering and radioimmunoassay methodologies. During my time in the industry I have managed teams of up to 30 members. I now provide consultation services to small and mid-size biopharmaceutical companies by building systems and processes to bring Quality Control departments into compliance with health authority guidelines and industry standards.
“Dave’s Analytical and Quality Control services were instrumental in the development of our SARS-CoV-2 neutralizing antibody program ...”
Services
- Build systems and processes to bring Quality Control departments into compliance with health authority guidelines and industry standards.
- Reference Standard Programs: Build process and establish procedures to advance reference standard programs to two-tiered systems consisting of primary and working standards.
- Specifications: Develop procedures to establish specifications and acceptance criteria as clinical programs progress and evolve.
- Stability Programs: Build phase-specific policies and procedures to establish drug substance re-test and drug product shelf-life periods.
- Data review: Establish policies and procedures for review of release and stability data for both in-house testing and testing by contract laboratories.
- Analytical Method Validation: Policies and procedures for analytical method qualification, method validation, compendial method verification and method transfer.
- Raw Materials programs: Raw material management policies and risk management.
D. Malliaros Consulting, LLC
David P. Malliaros, Ph.D.
29 Parkway Crescent
Milton, MA 02186
davemalliaros@gmail.com
1-617-922-7224
Connect with me on LinkdIn
Member of:
Testimonials
“Dave’s Analytical and Quality Control services were instrumental in the development of our SARS-CoV-2 neutralizing antibody program from pre-clinical through Phase III. He helped Adagio’s Quality department get up and running from company conception through the 2nd year. He was a key member in method qualification and validation and routinely was involved in analytical troubleshooting and investigations as they arose. Dave is well versed in ICH and regulatory guidelines and even assisted in our Reference Standards management. He also covered 100% raw data review exercises for our ADG20 program. Dave’s professionalism and expertise was seen in many forms. I would highly recommend working with Dave and would welcome the opportunity to work with him again.”
— Andres Berrio, M. S.: Director, Quality Control, Adagio Therapeutics
“Dave is very knowledgeable about Quality Control operations and systems. He helped us creating SOPs and other documents for analytical method transfer and validation, equipment, and QC operations in timely fashion.”
— Gustavo Rodriguez, Ph.D: Senior Manager, Quality Control, CRISPR Therapeutics
“Dave brings a wealth of experience developing Analytical, QC, and overall CMC strategies for biopharmaceuticals in large and small-company environments. He also possesses expertise in a wide range of analytical techniques, enabling him to develop/validate methods, carefully interpret data, and ensure robust testing in a QC environment. Most importantly, Dave is very easy to work with and a great team player; it was a pleasure working with him!”
— Steve Raso, Ph.D. Vice President, Quality Control, Adagio Therapeutics