Overview Ofichem Drug Product Services
Ofichem Drug Product supports pharmaceutical companies with integrated drug product development, formulation development, analytical R&D, dissolution testing, excipient analysis and transfer support.
This page gives a practical overview of how we work and which service route best fits your project.
Discuss your project with Ofichem
| If your project need is… | Start here |
|---|---|
| Developing or optimizing a formulation | Formulation Development |
| Analytical method development, verification or troubleshooting | Analytical Services |
| Dissolution or release method development | Dissolution Methods |
| Excipient identification, quantification or variability questions | Excipient Analysis / Excipia |
| Reformulation, repurposing or product differentiation | Dedicated Formulation Development |
| Full development program or CMO transfer | Contact Avivia |
How we work
Before starting a project, we align on the product, available data, development objective, regulatory context and commercial strategy. Based on this, we define a practical development plan with clear deliverables, timelines and reporting.
During project execution, we provide regular updates so that the project can be monitored and adapted where needed. Each project is concluded with a report tailored to the objective, whether it is a feasibility assessment, method development package, formulation screening report or transfer-support package.
Typically, our project plans are structured in multiple phases with relevant go/no-go decision points. At pre-defined stages during the execution of the project, the client has the option to decide whether or not to proceed with the current project, and/or to apply alternative development approaches. In this way, we can work together with our clients in the most flexible, cost-efficient and result-oriented way.
A critical factor to ensure a successful execution and completion of our projects is a direct and transparent communication between all parties involved. Before the start of each project, a detailed protocol plan is prepared and agreed upon, while during the project execution itself, frequent updates are provided to our clients allowing close monitoring and/or rapid adaptation of projects. Upon completion of each project, a detailed report is provided to the client.
Non-GMP
GMP
Feasibility phase
Project evaluation
Concept formulation selection
Strategy plan
Development plan
Concept Development
Concept formulations
Develop analytical methods
Test concept formulations
Formulation selection
Product Development
Optimize Formulation
Analytical method optimization
Stability screening
Select CMO
Process Development
Process development
Analytical method verification
Stability batches
Stability testing
GMP
Transfer to CMO
Technology transfer
Analytical method validation
Technical package
Production tech batch
Ofichem Drug Product can work on a stand-alone fee-for-service basis or, for selected full development programs, through alternative collaboration structures. The most suitable model depends on project scope, risk, timeline and commercial potential.
- Stand-alone analytical or formulation support
- Feasibility and troubleshooting projects
- Integrated development programs
- Transfer-support packages
- Selected co-development structures
Value-Added Generic and Hybrid Drug Product Development
Ofichem Drug Product supports generic, hybrid and value-added drug product development based on existing or reference products. Reference-product characterization, deformulation and excipient analysis can be combined with formulation development, analytical testing and comparative dissolution to translate knowledge of the reference product into a practical development strategy.
Projects may focus on developing a comparable generic formulation or on creating a differentiated product through improved formulation performance, modified release, an alternative route of administration, improved usability or other product characteristics. Development can continue through formulation optimization, stability assessment, process development and preparation for manufacturing transfer.
Formulation Development
Ofichem formulation strategy, prototype development and optimization.
Deformulation
Identification and quantification of reference-product excipients.
Reverse Engineering
Understanding how composition and formulation design determine product performance.
Dissolution Development
Comparative, discriminatory and biorelevant dissolution approaches.
Life Cycle Management and Reformulation of Branded Drug Products
Ofichem Drug Product supports pharmaceutical life cycle management and reformulation of existing drug products. Projects may be initiated to improve product performance, address stability or manufacturing issues, respond to changes in materials or suppliers, introduce a new strength or dosage form, differentiate an established product or prepare for changing market and competitive conditions.
Depending on the development objective, formulation optimization can be combined with analytical development, stability and degradation investigations, dissolution testing, excipient characterization and process development. Avivia can also support the translation of an improved formulation or process toward manufacturing and technology transfer.
Formulation Development
Reformulation, product optimization and development of new product concepts.
Analytical Services
Stability, degradation, impurity investigations and analytical method development.
Excipient Analysis
Investigating excipient variability, compatibility and material-related formulation problems.
Dissolution Development
Investigating and optimizing drug release and product performance.
Formulation and CMC Development of New Drug Products and NCEs
Ofichem Drug Product supports formulation and CMC development of new drug products and New Chemical Entities (NCEs), from early feasibility and formulation strategy through prototype development, analytical and dissolution method development, stability assessment, process development and preparation for GMP manufacturing.
Development programs may involve conventional oral dosage forms, poorly soluble compounds, parenteral and injectable formulations, modified- or controlled-release products, alternative routes of administration and other complex drug product concepts. The development strategy is adapted to the API properties, intended product profile, development phase and available preclinical, clinical and CMC information.
Formulation scientists, analytical scientists and dissolution specialists work together throughout development so that analytical and product-performance data can directly guide formulation decisions. Where a development program has encountered unexpected stability, dissolution, manufacturability or formulation problems, Avivia can also investigate the underlying cause and evaluate alternative development strategies.
Formulation Development
Feasibility, formulation strategy, prototype development and optimization.
Analytical Services
Analytical method development, stability-indicating methods and product characterization.
Excipient Analysis
Excipient selection, API–excipient compatibility, FRCs and formulation troubleshooting.
Dissolution Development
Release-method development and evaluation of formulation performance.
Network to Accelerate Drug Product Development
Ofichem Drug Product combines in-house pharmaceutical formulation and analytical R&D expertise with access to a trusted network of partners in areas such as preclinical development, GMP manufacturing and regulatory affairs.
Where relevant, this allows Ofichem Drug Product to support development programs beyond the laboratory phase, including CMO selection, process and analytical technology transfer, preparation of technical development packages and follow-up during transfer to GMP manufacturing.
Not sure where your project fits?
Many development projects require a combination of formulation, analytical and strategic input. Whether you are starting a new project, improving an existing product or troubleshooting a derailed development program, Ofichem Drug Product can help define the most suitable next step.
Contact Ofichem to discuss your development objective.