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 Director of Toxicology & Quality Services and her and her team look forward to the opportunity to collaborate with you to provide toxicological technical support ranging from categorizing active pharmaceutical ingredients to addressing safety impact of extractables & leachables (E&L).
Toxicological Product Risk Assessment
PharmEng Technology’s Toxicology services division offers a comprehensive solution for conducting risk assessment of therapeutic and excipients. Risk assessments are conducted to categorize a product 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 350 toxicology risk assessments and banding for both contract manufacturers and owner companies with pharmaceutical therapy and biotechnology products.
Extractables & Leachables (E&L):
PharmEng Technology 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), to ensure that the product safety, strength, quality, or purity is not altered.
Cleaning Validation
PharmEng Technology aligns cleaning validation with toxicological evaluation to provide tools to implement processes to achieve results in compliance, to meet regulatory expectations, and ensure patient safety. Customized solutions for a cleaning master plan are created and include health-based exposure limits (HBEL) considering identification of hazards and evaluation of the dose-response relationship.
Worker’s Compensation Expert Consultation:
PharmEng provides case review, written assessments, and expert testimony for worker’s compensation cases.
SELECTED ABSTRACT
Professional Poster at the International Society of Pharmaceutical Engineering Annual Meeting,2019.
SELECTED PUBLICATIONS
Haines, WT. 2023 APEX Grand Award for Public Health Concern for Special Report – Pandemic Progress: Industry’s Journey from 2020 to Today. Pharmaceutical Engineering, 42(3):44-47, 2022.
Haines, WT. Changing Lives with Gene Therapies. Pharmaceutical Engineering, 41(6):34-39, 2021.
SELECTED PAST SPEAKING ENGAGEMENTS
Haines, WT. “Understanding Extractables & Leachables:
May 16, 2023
ECU 4rth Annual Spring Pharma Conference
Haines, WT. “Using Risk Assessment to Minimize Cross Contamination.”
April 27, 2023
Comprehensive Industrial Course in the Preparation of Parenteral Products, University of Tennessee Health Science Center (UTHSC)
Haines WT. and Baird J. “Project Management.”
April 28, 2022
Pharmaceutical Sciences Group (PSG)
Haines, WT. “Manufacturing & Development of APIs. “
Part 1 – April 7, 2021
Part 2 – April 14, 2021
Pharmaceutical Sciences Group (PSG)
UPCOMING SPEAKING ENGAGEMENTS
Melanie McIntosh: “Bringing Pharmaceutical Quality Auditing into the Digital Age,” March 26, 2024 at 10:30 am–12:00 pm US PDT at Annual PDA Meeting.
Wendy Haines, professional poster: “Using Toxicological Risk Assessments to Minimize Cross-Contamination,” March 25-27, 2024 at Annual PDA Meeting
