Senior Pharmaceutical Formulation and Process Development Consultant Consultant with 33+ years experience in the CMC sector  

Ralph is a Senior Pharmaceutical Formulation and Process Development Consultant with more than 33 years of experience in the CMC sector. He has successfully developed stable and bioavailable new drug products and optimized existing drug products using innovative approaches and strong scientific principles.

 

Ralph received his BS in Pharmacy with a minor in Chemistry from Ohio Northern University. He started his pharmaceutical career with Stuart Pharmaceutical Company (division of ICI), and then Abbott Laboratories in parenteral manufacture before moving on to GlaxoSmithKline in a wide variety of domestic and international manufacturing and development roles.

Ralph’s primary expertise is in CMC solid dosage formulation and process development from pre‐clinical through marketing application.

He uses a systematic approach (quality-by-design) to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on formal experimental designs (DOEs) and quality risk management principals.

He uses enhanced knowledge of product performance over a range of material attributes, manufacturing process options and process parameters to define the product design space and meet the Quality Target Product Profile.

Development experience has included compressed tablets using wet granulation (continuous, high shear, microwave and fluid bed) and direct compression processing, nano-milling and spray drying, aqueous and organic tablet and pellet coating, hard gelatin capsule filling and 20+ years in soft gelatin capsule development.

He has successfully lead multi-national cross-functional development teams including development of compounds at third party contractors for US, European, Asian, South America and Japanese markets.

He is an ISO 9000 trained auditor. He has demonstrated success in developing quality products and manufacturing processes to consistently deliver products that meet the needs of his customers, regulatory agencies and the patient.

Examples of projects completed:

  • Optimization and technology transfer of commercial oral solid dosage manufacturing and packaging processes (soft gelatin capsules, film coated tablets, oral suspensions for reconstitution and hard gelatin capsules) for multiple large volume products at GSK and contract manufacturers. Total product revenues in excess of $6 billion/year.
  • Design and commissioning of commercial facilities and systems for soft gelatin capsule (2), oral solid dosage manufacture (batch and continuous direct compression, wet granulation & nano-milling/spray drying) (3), including automation and PAT of oral solid dosage lines (3), and pilot plants for solid oral dosage and parenteral aseptic and terminal sterilization fills.
  • Formulation development and reformulation of stable and bioavailable single entity (22) and combination (2) products. Developed a product through compression at commercial scale with less than 2 Kg of API using continuous wet granulation technology. Challenges included dosage with 80% API load, poor compression and coating adhesion properties.
  • Team leader for multiple international projects responsible for all aspects of the product development and CMC submission and interfacing of FDA PAI audits. All facility PAI audits performed with no citations.
  • Managed GMP training of personnel and compliance of the GSK North Carolina pilot plant resulting in successful FDA audits and use of the facility for FDA training of inspectors.
  • Lead team responsible for performing FDA studies used in development of the SUPAC guidelines with the University of Maryland.