Clinical Supply manufacturing
Manufacturing & Packaging
COREALIS Pharma offers clinical supply manufacturing and packaging services for oral solid dosage forms (tablets, capsules, and granules) for clinical studies to be held in the US, Europe, and Canada. This process may begin with the manufacturing of R&D/scale-up batches followed by GMP clinical supplies manufacturing. The dose strength drug products and their matching placebos can be manufactured using the following processes:
- Direct compression,
- Dry granulation,
- Wet granulation,
- Melt granulation
- Extrusion/ spheronization,
- Encapsulation (API-in-a-capsule by weight filling and by volume filling),
The manufacturing of clinical batches can be tailored for:
- Clinical batches for exploratory studies (IND),
- Clinical cGMP batches for Phase I, II, III, and bioequivalence studies,
- cGMP batches for submission to regulatory agencies, and
- cGMP placebos identical to the dose strength drug products.
COREALIS Pharma also offers small scale GMP clinical trial material packaging and clinical supplies material management and warehousing.
The clinical trial material packaging services includes:
- Blind or double blind packaging,
- Patient kit preparation,
- Clinical supplies warehousing and management.
When large scale clinical supply manufacturing batches are needed, COREALIS Pharma offers the possibility of transferring the formulations and the manufacturing processes of the drug products to a large scale manufacturing site.
The COREALIS Pharma staff takes it upon itself to troubleshoot and find simple solutions to complex problems throughout the manufacturing process.
Release & Stability
The COREALIS Pharma analytical group offers complete GMP analytical services for the GMP solid oral solid dosage forms manufactured by COREALIS Pharma. Both groups work in close collaboration with one another and coordinate their efforts in order to deliver the drug products on time, every time.
Analytical methods receive phase appropriate qualification/ validation according to ICH guidelines and respectful of regulatory requirements specific to the countries where the clinical studies are held (US, Europe or Canada).
These analytical services include:
- Phase appropriate qualification/ validation of analytical methods for API
and drug product release testing,
- cGMP release testing of APIs and drug products,
- cGMP release testing of excipients and packaging materials,
- cGMP stability storage and testing,
- Analytical methods validation for cleaning verification,
- GMP Analysis for cleaning verification,
- Analytical methods transfer to a cGMP laboratory of the client’s choice.
The most common cGMP analyses executed are:
- impurities (related substances),
- content and blend uniformity,
- dissolution (UV, HPLC),
- microbial limits,
- cleaning verification.
COREALIS Pharma prides itself producing rapid, accurate, and precise results on the chemical and physical properties of the finished products. The stability studies are executed according to ICH guidelines.
Technical Transfer & Dossier Support
COREALIS Pharma performs oral dosage form manufacturing for clinical trials but the relationship with clients does not end there. COREALIS Pharma’s experts are there to assist clients by providing the appropriate drug products information required for IND/CTA submission to regulatory agencies and, if necessary, execute the transfer of the drug products and processes to a large scale manufacturing facility. These transfers are carefully planned, structured, documented, and the work is supported until final approval and the manufacturing of the commercial batches. This formulation and process transfer and scale-up can also include analytical method transfer, if the situation calls for it.
Quality Systems & Qualifications
The facility owned by COREALIS Pharma has been designed, built and used solely for the purpose of formulation development and clinical supply manufacturing of pharmaceutical solid oral dosage forms. It is a cGMP facility and the processes are in full compliance with the ICH guidelines.
COREALIS Pharma’s Quality Assurance group is composed of scientists with impressive industry experience in cGMP analytics and manufacturing operations. COREALIS Pharma’s quality systems are continuously improving as they are reviewed on a regular basis by auditors mandated by our clients including Qualified Quality Persons (QP). COREALIS Pharma underwent a successful general audit by a QP auditor, meaning that the QP auditor does not need to re-audit COREALIS Pharma for each manufacturing campaign of European clinical supplies. This translates into substantial time and cost savings for clients.
COREALIS Pharma’s goal is to provide its clients full satisfaction by providing high quality services and delivering compliant phase appropriate drug products on time every time.