ALBANESE CONSULTING LLC
Partnering with you for your success
SERVICES
Your Strategic Partner
ANALYTICAL CHEMISTRY
Joe has supported pharmaceutical product development for products in late development (phase 3 and commercial). Joe can provide advice in the following areas:
Analytical Methods - Development, Qualification, Validation, Equivalence and Transfer of Chromatographic/Non-Chromatographic/Physicochemical Methods
Specifications - Design and setting of specifications and limits (ICH Q6A/B), including full familiarity with guidance on drug substances/drug products impurities (ICH Q3A/B). Review justification of specifications including organic impurities and degrandants, inorganic impurities, residual solvents, and nitrosamine evaluation.
Stability Studies - Design of studies (ICH Q1A-E) with respect to expected storage conditions and ICH climate zones, Evaluation of trends, interpretation of results.
Review Reports or Data - ensuring that the data collected is properly verified and that conclusions drawn in reports are appropriately justified by the collected data.
PHARMACOPOEIA COMPLIANCE AND SURVEILLANCE
Joe was responsible for the compendial vigilance process for all Janssen products ensuring compliance with all major global (USP, Ph. Eur., BP) and national (ChP, JP, IP, SP RF, Korea, Brazil) pharmacopoeias. He actively served in industry working groups such as the PhRMA Limited Duration Key Issues Team for compendial issues with USP, the EFPIA Biotherapeutics subteam for the elaboration of biotherapeutic compendial standards and was a member of the USP General Notices Project Team. He is currently active in the industry trade organizations NJPQCA, Midwest Compendial Discussion group and PDA that influence global health and compendial authorities.
Joe established a surveillance outsourcing model for the compendial vigilance process, freeing up internal resources to focus on the assessment of the identified changes.
With his knowledge and experience, Joe can evaluate your current compendial compliance process and suggest any improvements. Additionally, he can develop and implement a surveillance process with appropriate SOPs and Training Guides for your company. Joe can provide training on the need for compendial compliance and assess your company’s program for compliance. To find out more, please use the contact form below.
Joe is the co-author, along with Mark Wiggins, of a 12-part comprehensive series of articles on compendial compliance. Link to the articles is provided below.
PHARMACOPOEIA MONOGRAPH DEVELOPMENT
Joe can work with your company to submit the information needed to support a monograph submission from your company to the pharmacopoeia authorities. Based on your company’s approach to advocacy, Joe can suggest strategies on how and when to submit monographs.
Joe has experience developing monographs for small molecule and biotherapeutic drug substances and drug products with USP, Ph. Eur., BP, and SP RF. Schedule an introductory meeting today to determine if monograph submission is appropriate for your company.
TRAINING
Joe has delivered training presentations to global health authorities, pharmacopoeia authorities and at industry conferences on the following topics:
ICH Q3A and B
Development of Product Specific Monographs for Biotherapeutics
Method Development and Validation Strategies
Joe can develop and deliver training on any of the service areas listed above in this profile. The training can be tailored to the message you want to deliver. Contact Joe to find out how he can help you today.
EXPERIENCE
Joseph Albanese, Ph.D.
Managing Director and Consultant
Joe is the Managing Director of Albanese Consulting LLC, which he formed after more than 29 years experience in the pharmaceutical industry. Joe recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain and Quality in both Small Molecule and Bio-therapeutics development, manufacturing and supply.
Joe received a B.S degree. in Chemistry (minor: Business Management) from Elizabethtown (PA) College and Ph.D. degree in Chemistry from the University of Delaware. He is an associate member of Sigma Xi Research Fraternity. He is active in the American Chemical Society, AAPS, PDA and several Compendial Trade Organizations. Joe is the co-author of 23 published papers and numerous presentations at scientific meetings.
Joe believes in maintaining a positive mindset, creating partnerships with a purpose, and always striving for significant outcomes. When you work with him, you should expect a collaboration with transparency and consistency. Want to learn more? Contact Joe today for an initial consultation using the form below.