View of industry on FCS-free solutions. Dr. Jianan Fu PAN Biotech, Germany

Transcription

1 View of industry on FCS-free solutions Dr. Jianan Fu PAN Biotech, Germany

2 Company Profile 01 Based in Aidenbach, Germany 02 Founded in 1988, 60 employees, >10 million annual sales 03 Product: Media and supplements for cell culture 04 Deliver to industry and academia

3 Company Profile Foundation in Aidenbach 1988 Serum-free Products 2002 ISO 9001 ISO In-house R&D and Production 2008 Cell culture device PANSys3000

4 Company Profile New owner 2012 New building acquired 2014 Expanded storage capacity 1000 m Over 3000 references in international publications million sales Expanded lab and production

5 Portfolio 20% Growth factors Reagents Media supplements, Animo acids, vitamines, antibiotics, seperating solutions etc. 32% Sera Media Basal media, cell specific media 18% 829 products 11% FCS, Calf serum, Adult bovine serum, human serum and other animal sera 5% Molecular biology Molecular biological reagents Serum-free Serum replacements, serum free cell cultur e media 13%

6 Serum in cell culture market Global media market value in 2014: 3.7 bn US$ 39% Reagents 41% Media 20 % a 20% Sera Expected total annual growth rate: 13% Expected annual growth rate sera: 3.7% a -13% b a Data from Cell Culture Media, Sera, and Reagents Market - Global Industry Analysis, published b Data from Global Animal Blood Plasma Products and Derivatives Market, published

7 Serum in cell culture market Increasing demand Limited supply Serum becomes a limitation factor for the dynamic biopharma Complex supply chain: Slaughterhouse -> Agent -> Producer Seasonal: Raw material acquired twice a year industry Increasing price: Affected by the beef industry and climate change Turbulent pricing policy: Monopolization in certain regions/countries

8 Bio-pharma industry needs alternative(s) to FCS.

9 View of industry on FCSfree solutions The market is being transformed Monopolization PAA -> GE Health care Life technologies -> Thermo Fischer Hyclone -> GE Health care Outsourcing Strategic outsourcing of media design and cell culture media manufacturing Since 2009 Approx. 50 FCS producers 2017 Monopolized raw serum market - Stronger competition -

10 View of industry on FCSfree solutions FCS Higher costs Less independent - Extensive costs by sourcing, storage - Decreased market share professional media producers on the market % Growth in sales of FCS-free products Good Opportunity Culture Media More customized contract manufacture - Benefit from stable biochemicals market -

11 View of industry on FCSfree solutions Research customers Problems & Challenges Cell specific SFM - Specific formulation - Short of established SFMs ~ 2000 new cell lines per year and serum replacements SFM: Serum-free media Industry customers Problems & Challenges - Time and cost intensive media development - Customized formulation - New quality standards - Minimization of the costs Defined serum replacement PANEXIN

12 FCS replacement 01 Fully defined -> High reproducibility 02 Flexibility -> Design your own FCS-free Media! 03 Stable pricing (lower or comparable to FCS) Fully defined FCS replacement. 04 Functionality

13 FCS replacement Human pancreatic adenocarcinoma COLO357 Human prostate cancer cell line (PC3) rmsc & hmsc RASF (rheumatoid arthritis synovial fibroblasts) Human liposarcoma SW872 TAF (tumor-associated fibroblasts) SZ95 sebocytes Bone marrow derived macrophages (BMDMs) Human corneal epithelial cells (HCE-T, HCK) Human hepatoblastoma cell line Hep G2 The human breast cancer cell lines MCF-7 HeLa, MDCK, HEK Most tumor cells And more J Immunol. Prostate Int J Mol Med. Exp Dermatol. Am J Respir Cell Mol Biol. BRAIN Infect Immun. Anticancer Res. Vaccine. Int J Pharm. Free Radic Biol Med. Microbiology BMC Immunol. And more

14 Improved reproducibility M. Baker, Nature Replace 90% of FCS with Panexin

15 Panexin: FCS replacement MSC and ips Excellent morphology and reproducibility Co-culture In vitro tests, Toxicology, tissue engineering Animal/human tumor cells Shows very high efficiency. FCS can be often replaced directly 150 L per year for one pharmaceutical customer

16 Panexin basic Fully defined. No undefined ingredients such as serum, platelet lysate, tissue extracts or hydrolysates. All components with purity higher than 98% Panexin NTA Modified for adherent cells. Fully defined. Panexin pharma Chemically defined

17 View of industry on FCS-free solutions Challenges and outlook

18 FCS-free media: Challenges and Opportunities Flexibility 1 Individually customized formulation 1 Complex formulations A FCS-free cell culture medium could contain 50 to 300 different components Costs High expectation. An 2 Customer PAN 2 Manufacturing & sourcing Guarantee the availibility and the quality important factor to replace of FCS-free products (ISO 9001 & ISO or to reduce FCS 13485) Transparency No medium as a black-box 3 3 Commercial interests -- Transparency to pharma customers -- Information sharing with partners - Co-development with customers

19 FCS-free media: Outlook Good commercial concepts/products are important to replace FCS. Contract manufacturing Ethical concerns GMP Media - Minimal individual order 10 L - Media configurator - Serum as byproduct of meat industry - Xeno-free Vs. fully defined - Chemically defined - Cell culture media are NOT pharmaceuticals - Misleading definition - Extensive price level

20 FCS-free media: Outlook Cell banks Bulk chemicals industry Authorities Research