Chemistry, Manufacturing and Controls Consulting

Working with our clients' manufacturing facilities, PPD provides regulatory guidance in setting specifications, method development and validation as well as conducting stability studies. We can also identify contract manufacturers, arrange contract laboratory services and conduct good manufacturing practice (GMP) audits.

Our regulatory affairs department supports our clients' chemistry, manufacturing and controls (CMC) development to:

• Identify contract manufacturers specific to a client's needs
• Manage the contract manufacturing and/or analytical testing of the drug substance and/or drug product
• Provide regulatory guidance in setting appropriate manufacturing specifications, in method development/validation and in the conduct of stability studies relevant to the clinical phase of development
• Consult on GMP training and GMP feasibility audits as well as standard operating procedure writing
• Coordinate with a client and contractors involved to ensure all development work is performed properly and in a timely manner
• Prepare quality/CMC summaries for regulatory submissions
• Cooperate with regulatory authorities regarding chemistry and manufacturing issues

Drug/Biological Dosage Formulations

PPD has extensive experience in all types of drug/biological dosage formulations, as follows:

• Oral dosage formulations including tablets and capsules, sterile drug products, topical creams/ointments and suspensions, transdermal patches, nasal and inhalation products
• Blood products (plasma-derived or recombinant blood products, such as immune globulin, clotting factors, etc.)
• Gene therapies (retroviral, lentiviral and adenoviral vectors); somatic cellular and tissue therapies (autologous or allogeneic); xenotransplantation products; ex-vivo transduced cells; and synthetic peptides
• Vaccines (whole cell, killed, component, recombinant and combination); monoclonal antibodies; challenge agents; and synthetic and recombinant peptides
• Combination products (biologic-drug and biologic-device)