Whitepapers
The Relevance of Polymorph Screening in the Pharmaceutical Industry
by Bahareh Khalili, PhD, Manager, Solid-State Research & Development (SSRD) at Eurofins CDMO Alphora Inc.
Solid form screening, the activity of discovering and characterizing different solid forms of an active pharmaceutical ingredient (API), is an essential part of drug development. This screening process needs to be designed, performed and evaluated carefully, since the decisions made based on the screening may have consequences on the whole lifecycle of a pharmaceutical product. This paper discusses some basic principles about solid form screening and how we implement them at Eurofins CDMO Alphora to help our clients with this important task.
Current Strategies for Enhancing Bioavailability of Poorly Soluble Compounds: A Discussion on Commonly Used Technologies & Supporting Services
by Michelle Gischewski, Scientific Advisor, Drug Product Operations at Eurofins CDMO Alphora Inc.
Targeted bioavailability enhancement strategies can help improve the success of early drug candidates by maximizing the API’s exposure in early in-vivo studies. This whitepaper discusses commonly used technologies & supporting services that can help enhance bioavailability of poorly soluble compounds.
Drug Substance & CMC Development Tool Box: Selection of cGMP Starting Materials (RSMs)
by Graham McGowan, Ph.D., CMC and Regulatory Sciences Group Leader at Eurofins CDMO Alphora Inc.
cGMP Starting Materials (Regulatory or Registered Starting Materials, ‘RSMs’) represent the formal start of cGMP (current Good Manufacturing Practice) control, and potential start of validation for a given Drug Substance/Active Pharmaceutical Ingredient (API) manufacturing process.
This highlight article outlines main selection factors described in ICH Q11 and Q&A guides, and presents several examples of their application.
Key selection factors include:
- Placement in the overall synthesis, including separation from common reagents and from the Drug Substance
- Material characterization, analytical and stability knowledge
- Impurity profile and management, in particular of high risk impurities (e.g. DNA-reactive impurities or nitrosamines)
- Specification tests and criteria, and contribution to overall control strategy
- Source selection and manufacturing controls, including knowledge and management of process and process changes
Download the DS & CMC Development Tool Box here
API Development Tool Box: Case Studies in Multivariate Process Analysis
by Graham McGowan, Ph.D., CMC and Regulatory Sciences Group Leader at Eurofins CDMO Alphora Inc.
This highlight article is not intended to provide an in-depth statistical view of the use of multivariate tools as one component of API/Drug Substance development, but to illustrate approachable steps to adopt the methodology as one tool in the development tool box, alongside more traditional approaches.
Case study examples are provided to highlight the approachability and potential utility of the approach, from
early-phase development, to long-term manufacture.
Download the API Development Tool Box here
Stability studies and extension of shelf-life: The 10 commandments for Investigational Medicinal Products in EU. (March 2021)
by Pascal Puig, CMC-RA Director at Eurofins CDMO
Sometime it is good to go back to basics, knowing that everything is not carved instone with early phase IMPs.
This whitepaper does not impose mandatory commandments but presents warm recommendations. For IMPs in clinical trials we should refer to the EMA guidelines on the requirements for Quality documentation. There is one guideline for ChemicalsIMPs and another for Biologicals IMPs.
Generally we already apply them, since there are simpler and more flexible than the ICH guidelines about stability (ICHQ1 series and ICH Q5C) which apply to pre-marketing authorization or marketed medicinal products.
Click here to download the whitepaper
Anticipation of regulatory needs for nanotechnology-enabled health products (July 2020)
Launched in December 2017, H2020 project REFINE aims to develop a regulatory science framework for nanotechnology-enabled health products. Recently released REFINE’s White Paper summarises main regulatory challenges in the field and provides information on relevant legislative/regulatory frameworks and involved organisations.
The White Paper (available here) and related scientific publication “Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products” (available here) call for a discussion on identified challenges among the involved communities, including regulators, industry and academia. In order to better understand the needs and perspectives of different communities a short questionnaire is available here. The feedback should help to develop an improved version of the White Paper.
