cGMP Services Agere’s cGMP manufacturing and analytical services support clinical trial materials through Phase II. We offer our clients state-of-the-art facilities that include versatile cGMP manufacturing suites, a fully compliant cGMP analytical lab, and ICH stability storage. Agere’s integrated team of quality assurance and regulatory guidance specialists provide efficient and unified transfer of formulation development programs into clinical trial campaigns. Combined with Agere’s development services, our cGMP expertise also facilitates our clients’ applications for IND/IMPD.
cGMP Manufacturing Agere offers its clients cGMP manufacturing of Phase I through Phase IIb clinical trial materials using a wide variety of capabilities and unit operations. We accommodate client needs by providing drug intermediate forms and final drug products. Agere’s cGMP manufacturing expertise extends from the production of oral forms of BCS II-IV compounds to alternative routes of administration, including inhalation and topical. To learn more about our cGMP manufacturing, or if you require manufacturing support not listed here, please contact us.
Manufacturing Capabilities
- Spray drying
- Hot melt extrusion
- Hot melt granulation
- High shear homogenation and milling
- Tableting
- Encapsulation
- Roller compaction
- Milling and blending operations
- Drying/blending
Final Dosage Forms
- Tablets
- Capsules
- Powder for inhalation
- Alternative dosage forms (suspension, powder-in-a-bottle)
cGMP Analytical Agere offers a full-service cGMP analytical laboratory to complement our cGMP manufacturing operations. In-house cGMP analytical support with expertise in formulation-specific methodologies provides our clients efficient in-process and final release testing of Phase I through Phase IIb clinical trial materials. In addition, our clients depend on us for a broad range of cGMP analytical services, including method development to guide the transfer of pre-clinical formulation projects into cGMP manufacturing, ICH stability storage and testing, and analytical chemistry regulatory guidance. To learn more about our cGMP analytical services, or if you require support not listed here, please contact us.
cGMP Analytical Capabilities and Method Development
- Equipment cleaning verification and validation
- Finished product release testing
- In-process product testing
- Method validation/qualification
- Raw materials testing
- Stability storage & testing
- USP dissolution testing
Regulatory Guidance Agere’s integrated team of quality assurance (QA) and regulatory guidance specialists provide expertise on the most up-to-date FDA, EMA, MHRA and ICH regulations and guidelines. The Agere QA team has successfully led and completed a broad range of client audits, and also have experience in FDA, PAI and MHRA audits. Agere’s quality systems are designed and maintained to strictly adhere to the most rigorous quality standards. This quality-driven culture is put to practice by our technicians and scientists to de-risk our clients’ programs. For more information about Agere’s Q A and IND Support, please contact us.
Quality Assurance
- Quality agreements
- Document control
- Master batch records
- Materials control
- Customer notification and change control
- GAMP (Good Automated Manufacturing Practice) investigations
- CAPA (Corrective and Preventative Action)
- OOS (Out of Specification) investigations
IND/IMPD Regulatory Document Support
- Detailed project reports
- Content selection
- Writing and submission