Formulation/Final Drug Product Manufacturing
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DDA has aligned with partners that provide Drug Product Development that covers the entire process from the product idea to production of the registration file ready for submission.
Our Drug Product development starts with the screening of suitable formulations and processes to best meet the defined target product 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 DOE concepts.
Areas of focus include but not limited to solid dosage forms beginning at lab-scale batch which can then be scaled up to pilot-scale and/or commercial-scale batch sizes depending on exposure level.
Areas of focus for highly potent (oncological non-cytotoxic) drug compounds include activities in a dedicated area suitable to handle OEB4 compounds using PPE.
For highly potent, oncological both non cytotoxic and cytotoxic drug compounds we perform all development activities in a dedicated area with scale up in a GMP area suitable to handle OEB4 or OEB5 compounds respectively using PPE. In this area solid dosage forms can be manufactured by granulation, direct compression, and encapsulation with variable batch sizes.
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 1kg – 50 kg for clinical phase I – III studies. Furthermore, sourcing and blinding of comparators and clinical trial packaging can also be included as part of our pharmaceutical development services. Oral solid dosage forms for penicillin and cephalosporin have separate facilities. Capabilities span from preclinical development to commercial manufacturing.
Other areas of focus include: hormones, cytostatics, and ß-lactams in appropriate facilities. Our area also covers sterile forms such as solutions, lyofilised and emulsions as well as our selected project teams to support the entire process from the start of development until completion.
DDA partnered capabilities to include expertise in:
- Sterile emulsions
- Sterile solutions
- Lyofilised oncology
- Pre-filled syringes
- Clinical trial preparations
- Formulation development
- Oncological solid forms (capsules and tablets)
- Oncological parenteral liquid forms (up to OEB 5)
- Oncological parenteral lyofilised forms (up to OEB 5)
- ß-lactams in solid and sterile powder forms
- Hormones and hormone blockers in solid forms (up to OEB 4/5)
- Organic solvent granulation for highly potent (non-cytotoxic) compounds
- Clinical trial medication (also for highly potent compounds)
- Modified release tablets, two-layer tablets
- Capsule filling with different components (e.g. granules + tablets)
- Stick packs
Drug Discovery Alliances was recently certified by the Greater Womens Council and received the Women’s Business Enterprise National Council certification.
HUB Zone certification
Drug Discovery Alliances was recently HUB Zone Certified.