Improving life quality henriette valster hcm medical

S
Hightech Contract Manufacturing – Medical B.V.
The start of a new innovative company in Nijmegen!
Company History
(The initial idea)
Setup a Contract Manufacturing Organization for the development and
production of biological implants and devices based on human as well as
animal tissue.
Be an extension of Customers policy and business in the development and
production process.
Be a service provider in installation of technologies and production
processes at Customer Sites, globally.
Founder’s History
Biochemists with experience in (Contract) Manufacturing of Medical
Devices, Pharmaceuticals and Tissue Constructs.
Advising and supporting companies on operational, quality and regulatory
matters.
Extensive international network.
Complementary characters but share being independent, targeted and the
passion for water.
HCM-Medical Facilities (Kerkenbos 10113, Nijmegen)
Company History
(The Action Plan)
2014
• August : Decision to start CMO
• November : Registration of HCM-Medical B.V.
2015
• February : Selection of Facilities
• March : Start setup Business Plan
• April-July : Investor selection and presentation
• October : Investment process (almost) completed
• November : Clean room construction started
• December : Manager Production hired
2016
• January : Clean room construction completed
• First Customer contract signed
• April : Offical Opening of HCM-Medical
• First Inspection by Notified Body for CE License
HCM-Medical
Business Plan
Company Vision
Development and production of niche products for third
parties whereby through new technologies solutions are
provided for faster healing of the patient with oncological
applications as an important priority.
Business Plan
Company Mission
HCM-Medical BV, is a contract manufacturer that in close collaboration with the
customer develops products and implements technologies for the purpose of
manufacturing unique and hightech medical products.
► Driven by technology
► Focus on medical implants with unique proporties for niche applications.
► High level of customer satisfaction supported by added services:
- Product Development
- Validation and Registration
Business Plan
HCM-Medical Business
HCM Medical: a contract manufacturing company
HCM Medical, also known as Hightech Contract Manufacturing Medical, is a
contract manufacturing organization that develops and manufactures
products and implements technologies.
The purpose of the production is to develop and manufacture unique and
high-tech medical products for various medical applications which include
cardiovascular, urological, dermatological, dental,
ophthalmological and orthopedic applications.
At the same time, HCM Medical will put an emphasis on the need for tissue
products required in tumor surgery, development and production of tumor
vaccines and the development of drug-release products for local
treatment by implantation.
Business Plan
HCM-Medical CMO Services
Products or services
HCM-Medical can provide the following services:
•Production of products for customer within the current licenses, suchas:
• Medical Devices
• Pharmaceuticals
• Tissue (human)
•Develop new products, in collaboration with the customer, within the
possibilities and expertise
•Produce, on behalf of the customer, the first batches after product
development, for clinical studies or product registration
•Provide knowledge in the field of test method development
•Product (process) validation
•Product registration
Business Plan
HCM-Medical Technologies
HCM Technologies
Together with customers HCM Medical will specialize in developing and producing
products that have a biological origin; either the processing of human and animal
tissues to new implants as well the purification of biological materials such
as collagen for the production of high quality implants.
Technologies performed by HCM Medical, such as:
• Supercritical CO2 for the purpose of removal of cells and
other unwanted materials from tissues.
• Freeze-drying for the purpose of production of tissue constructs
• Continuous improvement of existing technologies and
introduction of new techniques: Electro-spinning, 3D printing, etc.
• Aseptic preparations; both formulating and filling under controlled
aseptic conditions.
HCM-Medical Investors
• 2 Founders of HCM-Medical
• Private Investor (Shareholder)
• Rabobank (Overheidsborgstelling)
• Mibiton (Financial lease equipment)
• Gelderland voor Innovatie (Innovation loan)
Clean rooms
Equipment
Working Capital
€750K
HCM-Medical Facilities
HCM-Medical Facilities
HCM-Medical Facilities
Products and Technologies
Supercritical CO2 technology (Extraction & Impregnation)
scCO2 Products and Technologies
Processing
Cleaning
Supercritical CO2
technology
overcomes the
shortcomings of
tradional tissue
processing
Drying
Drying of tissue
constructs as
alternative for
freeze drying
Coating
Impregnation
Impregnation and
coating of
antibiotics and
API‘s
Sterilization
scCO2 sterilization
for the purpose of
new product
development
Musculoskeletal tissue
Bone flaps
Femoral Heads
(Cancellous)
Sternum
Cortical bone
& Tendon
Mandibula
Vertebra
Soft Tissue
Trachea
Heart valves
& Pericard patches
Blood vessels
& Aorta patches
Skin
Urethra
Amniotic membrane
Tissue source
Product & Technology Development
• Grants for technology & product development
• Heart valves
• scCO2 sterilization
• scCO2 equipment development
Grants
(approved)
• Business partners & New customers
• Business collaborationsCustomers
Conclusion
Challenges:
 Investment (will we find the required amount?)
 Customers (will customers sign contracts?)
Successfactors and Pitfalls:
 Network (former contacts bring equipment, contracts, new businesses, employees etc.)
 Leadtime of investment process (6-10 months)
 Decision on Investorselection (conditions of investors)
Do’s and Don’ts:
 Write a readable Business Plan
 Invest in the necessary (no unnecessary decoration)
 Select appropriate facility (dedicated to the business and logistics)
Hightech Contract Manufacturing – Medical B.V.
Kerkenbos 10113
6546 BJ Nijmegen
www.hcm-medical.com
024-206 2971
Products and Technologies
Products
Tissues
• Cleaning of human and animal tissues for the purpose of tissue reconstruction in orthopaedics, dental,
cardiovascular, dermatology, trauma, urological, etc. applications.
Biological molecules
• Purification of collagen from animal tissue and production of collagen products & constructs for
multiple applications.
Licenses required:
1. HumanTissue license (IGZ)
2. ISO13485 MedDev (Notified Body)
Products and Technologies
Supercritical CO 2 as virus inactivation technique for bone; a mild way of processing.
Bokhorst A.G 1
, Al B2,
Valster H3
1
De Oude Gracht Groep
2
Sanquin Blood Supply
3
EMCM b.v.
Microbiological safety of bone allografts remains a significant concern. Many of the current
processing methods to reduce the risk of transmission alter the structure and characteristics of bone.
The Supercritical CO2 fluid technique is used in tissue banking as an alternative sterilization technique
because of its cleaning and bactericidal capacities, while maintaining the natural structure of the
tissue.
Aim of this study is to investigate the capacity of this ScCO2 processing method for bone to inactive
viruses as well
Materials & Method
Untreated cortical and cancellous bone particles ( 5 samples each) were spiked with different viruses
representing the critical virus groups, and processed with the following steps :: ScCO2 extraction of
debris, H2O2 30% washing step and NaOH 2M for prion inactivation. After each step the viral
removing or inactivating capacity was determined.
Results
Results of the validation studies [CF (log10 ± 95% CL)]
Treatment
Supercritical H2O2 NaOH Minimal
fluid 30% 2M Overall
CO2 (2 hrs at 40°C) (1 hr at 20°C) Virus
Virus extraction Reduction
BVDV ≥ 3.8 ± 0.4 > 5.2 ± 0.2 > 6.7 ± 0.2 > 15,7
CPV 0.5 ± 0.4 > 4.7 ± 0.3 > 5.7 ± 0.3 > 10,4
HAV 0.9 ± 0.4 > 3.7 ± 0.2 > 4.9 ± 0.2 ≥ 8,6
HIV > 6.4 ± 0.2 > 3.7 ± 0.3 > 5.6 ± 0.3 > 15,7
PSR > 5.7 ± 0.2 > 4.7 ± 0.2 > 7.1 ± 0.2 > 17,5
Minimal overall virus reduction of the SCCO2, H2O2,and NaOH of human bone.
Conclusion:
The processing of human bone with scCO2, H2O2 and Na OH results in a theoretical virus
reduction of minimum > 8,6.log 10 A processing method based on ScCO2 completely inactive
viruses, which makes it a valuable alternative to other more aggressive inactivation
techniques.
Products and Technologies
The supercritical process
Sterilization
Benefits of Using Supercritical CO2 Sterilization
• Low temperature and moderate pressure
- Ideal for sensitive organic materials or highly reactive materials
• Non-toxic (1)
- Compatible with allografts as well as xenografts tissue
• Able to penetrate to the interior of porous materials
- Reaches pathogens located within the cortex
• Good solvent capacity for lipids (1)
- Ideal lipid extractor
- Improved tissue cleaning
• Additive in sublethal dose (25-100 ppm) + scCO2 = synergistic effect and SAL6
sterilization
• Allows for Terminal sterilization (sterilization in final packaging)
1. Fages J, Marty A, Delga C, Condoret JS, Combes D, Frayssinet P. Use of supercritical CO2 for
bone delipidation. Biomaterials. 1994;15:650-656.
Supercritical tissue application
(an example)
1 of 27

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Improving life quality henriette valster hcm medical

  • 2. The start of a new innovative company in Nijmegen!
  • 3. Company History (The initial idea) Setup a Contract Manufacturing Organization for the development and production of biological implants and devices based on human as well as animal tissue. Be an extension of Customers policy and business in the development and production process. Be a service provider in installation of technologies and production processes at Customer Sites, globally.
  • 4. Founder’s History Biochemists with experience in (Contract) Manufacturing of Medical Devices, Pharmaceuticals and Tissue Constructs. Advising and supporting companies on operational, quality and regulatory matters. Extensive international network. Complementary characters but share being independent, targeted and the passion for water.
  • 6. Company History (The Action Plan) 2014 • August : Decision to start CMO • November : Registration of HCM-Medical B.V. 2015 • February : Selection of Facilities • March : Start setup Business Plan • April-July : Investor selection and presentation • October : Investment process (almost) completed • November : Clean room construction started • December : Manager Production hired 2016 • January : Clean room construction completed • First Customer contract signed • April : Offical Opening of HCM-Medical • First Inspection by Notified Body for CE License HCM-Medical
  • 7. Business Plan Company Vision Development and production of niche products for third parties whereby through new technologies solutions are provided for faster healing of the patient with oncological applications as an important priority.
  • 8. Business Plan Company Mission HCM-Medical BV, is a contract manufacturer that in close collaboration with the customer develops products and implements technologies for the purpose of manufacturing unique and hightech medical products. ► Driven by technology ► Focus on medical implants with unique proporties for niche applications. ► High level of customer satisfaction supported by added services: - Product Development - Validation and Registration
  • 9. Business Plan HCM-Medical Business HCM Medical: a contract manufacturing company HCM Medical, also known as Hightech Contract Manufacturing Medical, is a contract manufacturing organization that develops and manufactures products and implements technologies. The purpose of the production is to develop and manufacture unique and high-tech medical products for various medical applications which include cardiovascular, urological, dermatological, dental, ophthalmological and orthopedic applications. At the same time, HCM Medical will put an emphasis on the need for tissue products required in tumor surgery, development and production of tumor vaccines and the development of drug-release products for local treatment by implantation.
  • 10. Business Plan HCM-Medical CMO Services Products or services HCM-Medical can provide the following services: •Production of products for customer within the current licenses, suchas: • Medical Devices • Pharmaceuticals • Tissue (human) •Develop new products, in collaboration with the customer, within the possibilities and expertise •Produce, on behalf of the customer, the first batches after product development, for clinical studies or product registration •Provide knowledge in the field of test method development •Product (process) validation •Product registration
  • 11. Business Plan HCM-Medical Technologies HCM Technologies Together with customers HCM Medical will specialize in developing and producing products that have a biological origin; either the processing of human and animal tissues to new implants as well the purification of biological materials such as collagen for the production of high quality implants. Technologies performed by HCM Medical, such as: • Supercritical CO2 for the purpose of removal of cells and other unwanted materials from tissues. • Freeze-drying for the purpose of production of tissue constructs • Continuous improvement of existing technologies and introduction of new techniques: Electro-spinning, 3D printing, etc. • Aseptic preparations; both formulating and filling under controlled aseptic conditions.
  • 12. HCM-Medical Investors • 2 Founders of HCM-Medical • Private Investor (Shareholder) • Rabobank (Overheidsborgstelling) • Mibiton (Financial lease equipment) • Gelderland voor Innovatie (Innovation loan) Clean rooms Equipment Working Capital €750K
  • 16. Products and Technologies Supercritical CO2 technology (Extraction & Impregnation)
  • 17. scCO2 Products and Technologies Processing Cleaning Supercritical CO2 technology overcomes the shortcomings of tradional tissue processing Drying Drying of tissue constructs as alternative for freeze drying Coating Impregnation Impregnation and coating of antibiotics and API‘s Sterilization scCO2 sterilization for the purpose of new product development
  • 18. Musculoskeletal tissue Bone flaps Femoral Heads (Cancellous) Sternum Cortical bone & Tendon Mandibula Vertebra
  • 19. Soft Tissue Trachea Heart valves & Pericard patches Blood vessels & Aorta patches Skin Urethra Amniotic membrane
  • 21. Product & Technology Development • Grants for technology & product development • Heart valves • scCO2 sterilization • scCO2 equipment development Grants (approved) • Business partners & New customers • Business collaborationsCustomers
  • 22. Conclusion Challenges:  Investment (will we find the required amount?)  Customers (will customers sign contracts?) Successfactors and Pitfalls:  Network (former contacts bring equipment, contracts, new businesses, employees etc.)  Leadtime of investment process (6-10 months)  Decision on Investorselection (conditions of investors) Do’s and Don’ts:  Write a readable Business Plan  Invest in the necessary (no unnecessary decoration)  Select appropriate facility (dedicated to the business and logistics)
  • 23. Hightech Contract Manufacturing – Medical B.V. Kerkenbos 10113 6546 BJ Nijmegen www.hcm-medical.com 024-206 2971
  • 24. Products and Technologies Products Tissues • Cleaning of human and animal tissues for the purpose of tissue reconstruction in orthopaedics, dental, cardiovascular, dermatology, trauma, urological, etc. applications. Biological molecules • Purification of collagen from animal tissue and production of collagen products & constructs for multiple applications. Licenses required: 1. HumanTissue license (IGZ) 2. ISO13485 MedDev (Notified Body)
  • 25. Products and Technologies Supercritical CO 2 as virus inactivation technique for bone; a mild way of processing. Bokhorst A.G 1 , Al B2, Valster H3 1 De Oude Gracht Groep 2 Sanquin Blood Supply 3 EMCM b.v. Microbiological safety of bone allografts remains a significant concern. Many of the current processing methods to reduce the risk of transmission alter the structure and characteristics of bone. The Supercritical CO2 fluid technique is used in tissue banking as an alternative sterilization technique because of its cleaning and bactericidal capacities, while maintaining the natural structure of the tissue. Aim of this study is to investigate the capacity of this ScCO2 processing method for bone to inactive viruses as well Materials & Method Untreated cortical and cancellous bone particles ( 5 samples each) were spiked with different viruses representing the critical virus groups, and processed with the following steps :: ScCO2 extraction of debris, H2O2 30% washing step and NaOH 2M for prion inactivation. After each step the viral removing or inactivating capacity was determined. Results Results of the validation studies [CF (log10 ± 95% CL)] Treatment Supercritical H2O2 NaOH Minimal fluid 30% 2M Overall CO2 (2 hrs at 40°C) (1 hr at 20°C) Virus Virus extraction Reduction BVDV ≥ 3.8 ± 0.4 > 5.2 ± 0.2 > 6.7 ± 0.2 > 15,7 CPV 0.5 ± 0.4 > 4.7 ± 0.3 > 5.7 ± 0.3 > 10,4 HAV 0.9 ± 0.4 > 3.7 ± 0.2 > 4.9 ± 0.2 ≥ 8,6 HIV > 6.4 ± 0.2 > 3.7 ± 0.3 > 5.6 ± 0.3 > 15,7 PSR > 5.7 ± 0.2 > 4.7 ± 0.2 > 7.1 ± 0.2 > 17,5 Minimal overall virus reduction of the SCCO2, H2O2,and NaOH of human bone. Conclusion: The processing of human bone with scCO2, H2O2 and Na OH results in a theoretical virus reduction of minimum > 8,6.log 10 A processing method based on ScCO2 completely inactive viruses, which makes it a valuable alternative to other more aggressive inactivation techniques.
  • 26. Products and Technologies The supercritical process Sterilization Benefits of Using Supercritical CO2 Sterilization • Low temperature and moderate pressure - Ideal for sensitive organic materials or highly reactive materials • Non-toxic (1) - Compatible with allografts as well as xenografts tissue • Able to penetrate to the interior of porous materials - Reaches pathogens located within the cortex • Good solvent capacity for lipids (1) - Ideal lipid extractor - Improved tissue cleaning • Additive in sublethal dose (25-100 ppm) + scCO2 = synergistic effect and SAL6 sterilization • Allows for Terminal sterilization (sterilization in final packaging) 1. Fages J, Marty A, Delga C, Condoret JS, Combes D, Frayssinet P. Use of supercritical CO2 for bone delipidation. Biomaterials. 1994;15:650-656.