STERILE INJECTABLE FORMULATION
Drug Product Development
CordenPharma’s pharmaceutical Drug Product Development covers the entire process from concept to clinical and commercial manufacturing.
Our Drug Product development starts with the screening of suitable formulations and processes to best meet the defined target product profile. These formulations / processes are analysed to identify the critical parameters potentially impacting the quality of the required defined target profile. Both formulations and processes are challenged and optimized to ensure that the Drug Product can be manufactured by a robust and efficient process according to QbD concepts.
During scale-up critical parameters are established and verified with appropriate control strategies to ensure that quality attributes are consistently met for validation during routine manufacturing. Besides our dedication to quality we also focus on optimization of process ranges and robustness in order to improve manufacturing efficiency and reliability within a continuous improvement process.
For solid dosage forms we start at lab-scale batch sizes of approximately 100 g – 5 kg for all of our technologies, which can then be scaled up to pilot-scale and / or commercial-scale batch sizes depending on exposure level.
In particular as it relates to highly potent and oncology non-cytotoxic drug compounds we perform all development activities in dedicated areas suitable to handle OEB 4 compounds. In these areas solid dosage forms can be manufactured by high shear granulation, fluid bed granulation, direct compression, granule & tablet coating, and encapsulation at batch sizes of 100 g to several kilograms.
Furthermore, oral solid dosage forms for both non-potent and highly potent drug compounds can be manufactured in separate areas under cGMP. Thus, we offer bulk manufacturing from 1 kg – 50 kg for clinical phase I - III studies. Oral solid dosage forms for penicillins and cephalosporins have dedicated facilities at our site in CordenPharma Latina.
In parallel to formulation and process development, CordenPharma draws upon combined resources across multiple cGMP facilities to develop the analytical methods for drug compounds, excipients and Drug Products, conduct the necessary stability studies according to ICH requirements and validate all methods and processes.
For commercial-scale production we manage and perform the transfer of methods and processes from the donor site, the scale-up of the process to the appropriate level and the full validation program for filing.
CordenPharma’s expert development teams work on projects for solid dosage forms with highly potent substances such as hormones, cytostatics, and beta-lactams in appropriate facilities. Our area also covers sterile forms such as solutions, both lyophilised and emulsions, as well as our selected project teams to support the entire process from the start of development until completion.
Drug Product Contract Manufacturing
CordenPharma’s state-of-the-art formulation facilities are equipped to manufacture solid dose and parenteral formulations. The broad spectrum of capabilities allows formulations of highly potents, oncologicals, cephalosporins, penicillins, and hormones or hormone blockers.
Handling of sterile powder-filled vials, lyophilized vials, oral suspension powders and injectable liquids could be offered as well as specific techniques such as sterile emulsion technology and pre-filled syringes.
Special solid dose formulations like two-layer tablets and filling of capsules with powder granules or mini-tablets are manufactured on our equipment.
Our sites are inspected and approved by EMA, FDA, Anvisa, TGA and the Japanese Authority (PDMA), allowing our customers to distribute products manufactured by CordenPharma for all regulated markets worldwide.
CordenPharma’s capabilities to support customers in Drug Product Manufacturing include expertise in:
- >> Sterile Solutions & Emulsions
- >> Lyophilized Vials
- >> Pre-filled Syringes
- >> Sterile Cartridges
- >> Ampules
- >> Highly Potent & Oncological Solid Forms (capsules & tablets)
- >> Cytotoxic & Cytostatic Parenteral Liquid & Lyophilized Forms (up to Category 4)
- >> Beta-lactams in Solid & Sterile Powder Forms
- >> Hormones & Hormone Blockers in Solid Forms
- >> Organic Solvent Granulation for Highly Potent Compounds
- >> Modified Release Tablets, Two-Layer Tablets
- >> Pediatric Oral Solid Dose Formulations
- >> Animal Health Dedicated Oral Solid Dose Facility
- >> Capsule Filling with Different Components (e.g. granules + tablets)