Toxicology
Our experts ensure clients’ safety by protecting them from pharmaceutical hazards
At PharmEng Technology, we understand the importance of evaluating the toxicity and safety of biopharmaceuticals, therapeutic proteins, chemicals, active pharmaceutical ingredients, and components.
PharmEng Technology has a unique staff base to accommodate your toxicological needs.
Dr. Wendy Haines, a board certified toxicologist, is the Associate Director of Technical & Scientific Services at PharmEng Technology, offering Toxicology solutions, such as:
Toxicology Safety / Product Assessments:
PharmEng Technology’s Toxicology division offers a comprehensive solution for conducting risk assessment of a therapeutic. A risk assessment is conducted to categorize active pharmaceutical ingredients to prevent recalls and ensure patient safety; worker safety; pharmaceutical cleaning limits; and an overall banding characterization of a product. Our board-certified toxicologist and team have conducted more than 250 toxicology risk assessment categorization and banding for both contract manufacturers and owner companies with traditional pharmaceutical therapy and biotechnology products.
Cleaning Validation:
PharmEng aligns cleaning validation with toxicological evaluation to provide tools to meet regulatory expectations, implementing results in compliance, and patient safety. Customized solutions for cleaning validation are created and include health-based exposure limits (HBEL) considering identification of hazards and evaluation of the dose-response relationship.
Extractables and Leachables:
PharmEng consultants will work alongside you to evaluate your manufacturing process, container closure systems (CCS), and packaging to assess materials and contact chemicals that have the potential to produce extractables and leachables (E&L), which may be inherently toxic and can contaminate drug products manufacturers and owner companies with traditional pharmaceutical therapy and biotechnology products.
Workers Compensation Expert Consultation:
PharmEng consultants will work alongside you to evaluate your manufacturing process, container closure systems (CCS), and packaging to assess materials and contact chemicals that have the potential to produce extractables and leachables (E&L), which may be inherently toxic and can contaminate drug products manufacturers and owner companies with traditional pharmaceutical therapy and biotechnology products.
SELECTED ABSTRACT
Haines WT and VanBershot J. Changing Role of Toxicology within Cleaning Validation with Regards to Industry Trends and Regulatory Requirements.
Professional Poster at the International Society of Pharmaceutical Engineering Annual Meeting,2019.
SELECTED PUBLICATIONS
Haines, WT, and Rock, ME Avian Flu
– Is my Company Prepared?
Pharmaceutical Engineering, November/December 2006
PAST SPEAKING ENGAGEMENTS
Manufacturing and Development of API’s – Dug Development of APIs.
Part 1 – April 7, 2021
Part 2 – April 14, 2021
Pharmaceutical Sciences Group