Confirmed title: High potent API manufacturing at FAREVA

20 June: 10:30 - 10:45

Dr Christian Miksch, Director Sales API, FAREVA

ABSTRACT

Dr. Christian Miksch, Sales Director API, will speak about the capabilities of Fareva to manufacture high potent APIs from small scale to large scale.

BIOGRAPHY

Christian Miksch is currently Director Sales API at Fareva; the group is a top 5 CDMO globally with 35 production sites around the world focusing on drug substance and drug product development and manufacturing. 4 API sites in Germany & France and 13 DP sites in Europe & USA can offer a wide range of capabilities. Special expertise has been developed in the field of HPAPIs, sterile APIs and steroids. Christian obtained his PhD in organic chemistry from the University of Munich (LMU) in 2001. His career started with his own Biotech company, which developed anti-cancer APIs. 2005 Christian has joined DSM as lab head and developed API manufacturing processes. Starting in 2006 he worked for Pfizer Center Source in Germany as Project and Validation manager. He has joined the Sales team in 2011, when the production site has been sold to Fareva. Since then he is responsible for exclusive business and generic API business for all API manufacturing sites in the EMEA region.

COMPANY PROFILE

Fareva is a top 5 CDMO globally with 40 production sites around the world focusing on drug substance and drug product development and manufacturing.

Highlights of Fareva Corporate:
• 5th largest CDMO in world by revenue – €1.6 billion revenue in 2018
• 40 Production Sites and more than 12,000 Employees

Highlights of Fareva API:
• cGMP small molecule manufacturing for clinical programs and commercial production
• First and only company in the world to receive SafeBridge Certification to handle high potent drug substance and drug product at the same facility
• Milling and Micronization
• Aseptic processing of APIs (crystallization, micronization and packaging of API)
• Programs range from 1kg to 50MT annually
• World class process chemistry team
• High potent and cytotoxic APIs
• Steroids
• Conventional APIs (not potent)
• PSD and Polymorph control
• Global registrations (100+ DMFs in US, Canada, Japan, Europe)
• Sterilization of API by Ethylene Oxide
• Experience across a broad range of chemical classes – more than 200 different molecules

Highlights of Fareva Formulation and Drug Product Manufacturing:
• Ophtalmic forms (BFS, conventional and preservative-free bottles)
• Injectables (freeze-dried vials, ampoules and pre-filled syringes)
• Aerosols (conventional and bag on valve) and sprays (mechanical, preservative free)
• Suspensions, solutions and gels (bottles, sachets and stick-packs)
• Granules and powders (sticks packs, sachets, bottle); tablets (uncoated, coated, sugar coated) and capsules (blisters and bottles) with cytoxic expertise
• Creams, ointments, gel and jellies (single dose, sachets, alu, polyfoil or plastic tubes); sterile ointments and gels (polyfoil or aluminium tubes)
• Suppositories & ovulas
• Food supplements; herbal tea (grade pharma or not)
• Narcotics management and expertise (3 sites)