The TA101 GOCLIN consortium is constituted by 3 SMEs and 4 RTD providers located in several European countries, as described below.
TechnoPhage (TP) is a multiplatform drug discovery and development company involved in the R&D of new molecules in diverse therapeutic areas. It is run in three business units, each of them focused on a particular technological platform, one of which is the Technology of Antibody Fragments (small domain antibodies) directly involved in the development of TA101.
The company has several patent applications, partnerships with several small and mid-sized pharmaceutical companies and 12 programmes in its R&D pipeline. The overall strategy of TP is to generate new therapeutics/assets in early phases of development and further on enter into partnership deals for preclinical or clinical development or both that will ultimately lead to selling/out licensing deals.
TP develops recombinant small domain antibody fragments (sdAbs) for therapeutics of human diseases. The structure and extreme stability of sdAbs enables them to engage therapeutic targets that are inaccessible to conventional antibodies. The most advanced programme corresponds to the development of TA101.
Q-Biologicals (QB) is a biotech company focused on providing services in the field of process development and manufacturing of recombinant proteins, viruses and live cells.
These services are provided in a two-way approach: (1) Process and analytical method development and manufacturing services, including cGMP production, and (2) Consultancy based on hands-on experience. The principal technological expertise of QB is the production of recombinant proteins derived from microbial as well as eukaryotic systems, purification of recombinant proteins for research purposes and with pharmaceutical grade quality, including formulation development and stress stability studies. QB has also an extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and in-depth knowledge of working under industrial and cGMP quality requirements.
3. Amspar, B.V.
Amspar (AMS) has access to unique know-how associated with the technology (patent pending) to produce ceramic microneedle arrays as well as the development of intelligent skin patches that provide pain free, discrete and easy patient controlled treatments and health applications.
These ceramic microneedle arrays are tuned to provide a wide range of functionalities. The technology was originally developed at the University of Twente and still today the knowledge on micro- and nanofluidic transport both in patch and in micro needles is being expanded. Contract research with the microneedle arrays technology is being done at various knowledge institutes. As such, these microneedle arrays provide a practical and easy method for sampling and administering of substances relevant to the user, which is particularly suited for administering TA101.
Through its partners AMS has access to top expertise in the following fields: micro and nanotechnology, microelectronic devices, microfluidics, optical instrumentation, chemical technology and applied physics.
This unique technology offers top products with different designs concerning: shape of the microneedle tip, arrangements of microneedle in array, number of microneedles, and surface specifications.
Microcreate (MC) is an independent company providing microelectromechanical systems (MEMS) foundry services, consultancy and fabrication of microdevices for corporate and academic research laboratories who want to outsource cleanroom processing and might not have access to critical equipment and technologies as provided by the Mesa+ NanoLab at the University of Twente. The company was founded in 2012 by ir. Kechun(Kees) Ma, working as cleanroom freelancer (ZZPer), having more than 10 years of experience in MEMS fabrication at the Transducers Science and Technology (TST) research group at the University of Twente, The Netherlands.
SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for bio-pharmaceutical companies, SGS provides clinical trial management (Phase I to IV) services encompassing clinical project management and monitoring, data management, biostatistics, PK/PD Modeling & simulation and regulatory consultancy. SGS’ clinical unit located in Antwerp, Belgium with a total of 92 hospitalization beds has successfully passed several US FDA inspections during recent years. For optimized early phase clinical trials, SGS features Sample tracking for safety lab data interfaced with Oracle for PK samples, Full eSource clinic automation (EDC), GMP pharmacy for on-site formulation and a Biosafety Level 2 quarantine facility.
SGS has a wealth of expertise in: First-In-Human studies, QT/QTc prolongation, radio-labeled 14C ADME & PET scan trials, viral challenge testing, biosimilars and complex PK/PD studies. For a qualitative and faster patient recruitment across Americas and Europe, clients can also count on SGS’ large data base of investigators and key opinion leaders with an high therapeutic expertise in Infectious Disease & HIV/HCV, Vaccines, Oncology and Respiratory. Clients benefit also from the favorable regulatory environment in Belgium with very short phase I trial approval.
SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, virology and protein analysis.
Laboratoires Plasto Santé (LPS) is active in the field of topical and transdermal systems and has an industrial and technology expertise and know-how in the development and production of such systems, including but not limited to reservoir patches, matrix patches, impregnated patches and matrices and all types of adhesive pharmaceutical drugs and medical devices products.
It is the first and only French company able to manufacture pharmaceutical patches and adhesive medical devices, with its first estradiol (Hormone Replacement Therapy) patch produced since 1994 for the European market and since1998 for the US-Canadian market. Its factory operates according to the International current Good Manufacturing Practices (cGMP)
standards for a wide range of TDS products covering 3 major technology’s segments: Matrix patches, Reservoir patches, Advanced Adhesive Medical Devices with or without active ingredients, for all of which the company has extensive experience.
ARTES Biotechnology GmbH (ARTES) is an R&D company in the biotechnology sector existing since 2002. ARTES specializes in recombinant protein production, process development (especially high quality in know-how and equipment for fermentation and downstream processing) in microbial expression systems and is a technology provider for pharmaceutical processes. It focuses mostly on microbial organisms like yeast (Hansenula polymorpha) and bacteria (E.coli). Strain generation is achieved by state-of-the-art molecular biology techniques.
ARTES is holding worldwide exclusive licensing rights on this superior expression technology for various application fields. ARTES’ staff has more than 15 years of experience in commercial project management in heterologous gene expression and process development, especially in the handling and exploitation of the patented Hansenula polymorpha technology platform. ARTES has strategic collaboration partners around the world to offer customer tailored service packages in the field of recombinant protein production such as: gene analysis and design; production strain selection; fermentation development; downstream processing; process upscale, and large scale cGMP production.