Working hand-in-hand with you

Our dynamic, multidisciplinary team offers agile, customized solutions for your molecules as they move from early to late stage clinical development.

Together, we can help you create sustained release drug products, add value to unlock longer product lifecycles and in the longer term, help you create a more effective and patient-compliant drug product; meaningful differentiation in a fast-growing, competitive market.

Benefits of partnering with InnoCore

  • Experts in long-acting and sustained release injectables
  • From feasibility through clinical development to commercialisation
  • Expertise in working with clients from large to small. We will partner with you and provide bespoke solutions specific to your product.
  • Wide ranging solutions for all compounds, including fragile peptides to more complex proteins and antibodies.
  • Internationally recognized with regulatory approval for SynBiosys® in EU, Japan, and Asia.
  • Clinically proven: in vitro / in vivo data, no adverse local or systemic effects.
  • Biocompatible and safe formulation platforms: extensive biocompatible/toxicity data package
  • Adds value: easy-to-scale, added intellectual property
  • Varied dosage formulations: microspheres, injectable implants and in-situ forming depots or gels
  • A range of injection type: systemic and local, including subcutaneous, intramuscular, intravitreal, intracardiac, and intra-articular
  • Therapeutic focus: oncology, cardiovascular, diabetes, CNS, rare diseases, infectious diseases, ophthalmology, women’s health, endocrinology, animal health

Using SynBiosys®, we extended peptide release to over 3 months with more than 90% activity retained. The release profile was also phenomenal.

Lead scientist, anonymised client programme

What type of drug developer are you?

Whether you are a Large Pharma, Biotech, Generic or Animal Health company, InnoCore’s bespoke offering will support you in developing unique long-acting dosage forms of your API

 

A flexible collaborative process

Different structures of license and development agreements are available, depending on your needs and preferences.

We create bespoke teams with a mixture of expertise depending on the project, that works for you, not only during the first feasibility phase, but also during all subsequent product development phases.

Supporting you every step of the way journey from feasibility, preclinical and clinical testing

At InnoCore, our state-of-the-art facilities and experienced team support you every step of the way through the formulation of your drug product and manufacturing journey.

Once each project is complete, we can transfer to you or your cGMP contract manufacturing partner.

Our process in summary

Feasibility program

Feasibility studies for compatibility
Polymer customization
Encapsulation efficiency and API integrity

Offering customized solutions for your unique challenges

  • API integrity
  • Matching polymer technology
  • Target dosage form
  • Release duration
  • Loadings

How do we support you through the early stages of feasibility?

Preclinical Development

Robust analytical validation
Process scale-up & optimization
GLP tox manufacturing

Developing reliable & robust process for manufacturing

  • Risk-based approach
  • Phase appropriate identification of critical process parameters
  • Scale-up for in-house GLP-tox manufacturing (up to 250g)
  • Stability studies

How do we assist you through the process, scaling and GLP process?

Clinical Development

cGMP batches

Scaling from grams to Kgs

  • Test for Robustness
  • Technology transfer to cGMP partner
  • Aseptic manufacturing of cGMP material
  • Process and analytical method validation

 

Easy-to-scale manufacture

Whether it’s just a few grams for a small research project of kilograms for clinical trials, we offer inhouse manufacturing of material for GLP-tox studies followed by technology transfer to our customer cGMP facilities or our partner network, if required.

Regulatory support and quality assurance form an integral part of our partner support services.

Dedicated production and quality control documentation is laid down with compliance to international high quality standards.

Extending the product life cycle

We can add tangible value to our partners’ drug programmes by translating their peptide or protein molecules into stable, scalable LAI drug products that maintain their essential characteristics.

The combination of our technology and our customers’ molecules can provide novel IP protection for our clients and creating higher entry market barriers for competition.

Future-Proofing Your Drug Product with InnoCore

InnoCore is actively developing future versions of SynBiosys® to support:

  • High-loading peptide/protein formulations for even fewer injections
  • Liquid LAI formats with reduced viscosity for patient-friendly dosing
  • Creating additional IP protection and higher entry market barrier for competition

Our aim is to extend SynBiosys®’s data package through InnoCore-formulated LAI reaching commercial status and in time, a SynBiosys® LAI reaching blockbuster status.

Your Success is our Success

We believe in the power of partnerships – the added value of combined experience, know-how and skills – and to become an extension of our partners’ teams.

We are open to partnering and collaboration opportunities that complement our expertise and boosts the innovation process. If you are a developer and would like a discussion, please get in touch.

Partnering with InnoCore
If you are interested in developing a new sustained release product with InnoCore or would like to discuss the potential of inlicensing new sustained release technologies, get in touch.

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