Category Archives: Case Studies

Artificial organ quality system

A start-up company developing a tissue product used in organ replacement asked for Chimera’s help in establishing a quality system that was compliant with CGMP, QSR and Good Tissue Practice requirements. Chimera worked with the QA department in structuring the quality system and drafting quality policy and procedures. Chimera also recommended that since the shipping container contained functional elements its design should also be developed under a medical device design control system.

Biologic-device bridging strategy

A biotech manufacturer sought Chimera’s advice on bridging strategy design to achieve approval of a pre-filled cartridge-injection pen following the approval of a presentation containing a similar but not identical drug formulation. Prior clinical studies had been conducted with vialed product which utilized drug-contacting materials that were different from those to be used in the manufacture of the cartridge-injection pen. Chimera assisted the manufacturer in the development of a Type C Meeting briefing document which was submitted to CDER division responsible for the regulation of the combination product. Chimera later assisted the manufacturer with interpreting FDAs written responses and planning subsequent development and submission of a sNDA.

Biologic-device delivery device switch

A biotech manufacturer sought to switch a vialed lyophilized injectable biologic to a liquid pre-filled cartridge and pen. There was no significant change in drug-contacting materials. Chimera assisted in planning comparability, compatibility and stability protocols and drafted CMC documentation for the sBLA.

Biologic-device reconstitution and delivery device stability

A biotech manufacturer sought Chimera’s advice on assessing stability parameters of the diluent chamber of a two chamber liquid-dry reconstitution cartridge containing a lyophilized biologic. Chimera provided technical strategy, specifications and a technical approach for the separate determination of the stability of the diluent chamber, the lyo-drug chamber and the reconstituted drug solution.

Biologic-drug Combination Product

A drug manufacturer sought Chimera’s advice on clinical development, marketing authorization and labeling strategy for the combined use of its drug with a licensed biologic where the biologic manufacturer was not collaborating on the development of the combined use of the two products. Chimera prepared a strategy document for the drug manufacturer summarizing development, registration and labeling options available to the drug developer the under these circumstances.

Biosimilar with Delivery Device

Chimera provided advice to an ex-US generic pharmaceutical manufacturer on 505(b)2 NDA strategy related to drug delivery device comparability for a biosimilar regulated as a drug. This included providing advice and interpretation of FDA inputs from a previous Type C meeting and reviews of publicly available information about the innovator/reference drug, in particular its delivery device.

Cellular therapy quality system

A biologics developer sought advice on quality system structure to support clinical development of an encapsulated cellular therapy. Chimera conducted an audit of the manufacturing facility and made recommendations intended to enhance the quality system and meet a level of CGMP compliance consistent with current regulations and guidance for an investigational biological product.

Device-drug kit manufacture

A device manufacturer sought Chimera’s advice on stability studies to show that the shelf-life of a drug constituent part was not negatively impacted by the kit sterilization process. Chimera developed technical testing protocols to assess the effects of the kit sterilization method on the drug formulation.

Drug delivery device component selection

A pharmaceutical company developing drug product formulations containing novel excipients which were incompatible with conventional prefilled syringe elastomeric components and lubricants sought Chimera’s help in selecting syringe components that would be compatible with the novel drug formulation. Chimera surveyed available component and lubricant alternatives and made recommendations on test protocols to evaluate their use in prefilled syringes containing the drug formulation.