INJECTABLE DRUG DELIVERY ARTICLES

fundamental comparison metaphor or analogy-GettyImages-2191773530 Comparing Advanced Modality Needs, Part 1: Manufacturing

ADCs, AOCs, ATMPs, cell and gene therapies, and oligonucleotide therapeutics represent distinct but interconnected approaches to precision medicine. Let's take a closer look at their manufacturing needs.

INJECTABLE DRUG DELIVERY VIDEOS

Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.

INJECTABLE DRUG DELIVERY RESOURCES

INJECTABLE DRUG DELIVERY SOLUTIONS

  • Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.

  • More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.

  • AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

  • This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.

  • The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.

  • Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.

  • AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.