For Wyeth Lederle Vaccines and Pediatrics (U.S.), prior to their takeover, PCS performed a U.S. FDA pre-approval inspection of Wyeth's Pneumoconjugate vaccine.
The following area's were examined during the pre-inspection audit:
- Filling operations,
- Bulk operations,
- Quality Control,
- Fermentation,
- Purification.
The audit was concluded with good result.
Wyeth‑Lederle Vaccines & Pediatrics is a pharmaceutical business unit that focused on research, development, manufacturing, and marketing of vaccines and pediatric-related drugs.
Key highlights of its operations include:
Vaccine research and production, particularly for children’s immunizations like DTaP (diphtheria, tetanus, acellular pertussis) and pneumococcal conjugate vaccines
In December 1996, the U.S. Food and Drug Administration (FDA) licensed Wyeth‑Lederle to distribute ACEL‑IMUNE®, a combined DTaP vaccine for infants and children aged 6 weeks to 6 years. This vaccine offered fewer side effects than whole-cell pertussis formulations and was thus positioned as a safer alternative
The company also participated in the development of pneumococcal conjugate vaccines, which are crucial for preventing invasive pneumococcal diseases in children.
Historically, Wyeth‑Lederle was part of the larger Wyeth pharmaceutical organization, which was later acquired by Pfizer in 2009.
