Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.
Eyeing Up Success in Fill/Finish
Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.
Limits and Developments in Dissolution Testing
Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.
Injecting Innovation into Drug Packaging
Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.
Overcoming Vaccine Development Challenges
Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.
Focusing on Accelerated Formulation Strategies
Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.
Blocking the Threat of Counterfeit Medicines
After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.
Limitations and Advances in Dissolution Testing
A Watchful Eye on Pharma: Promising Drugs and Changing Bio/Pharma Landscape
COVID-19 has placed bio/pharma in the spotlight of global media, but away from vaccines there are other prospective pipeline treatments that will be worth watching.
Securing Each Dose: Reducing Falsification Risk with Dosage Level Authentication
Dosage-level authentication provides an added digital layer of security for pharmaceutical companies to ensure their products are not exposed to falsification.
Mitigating Risk in Scale-Up
The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.
Reviewing Recent Bioavailability Research
Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.
Demonstrating the Value of Collaboration
The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.
Meeting CGT Demand
More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.
Oncoming Elemental Impurity Analysis
Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.
Developments Driving Drug Delivery
Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.
Approaching Elemental Impurity Analysis
In Short Supply
COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.
Delivering a Wealth of Expertise
Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.
Balancing Innovation Protection and Affordability
Although a necessity, companies must strike a critical balance between protecting innovations with IP and providing affordable access to medicines.
The Outlook for a Year of Change
Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.
Overcoming Biologic Drug Formulation Hurdles
The right partner can help companies overcome key formulation challenges for biologic drugs.
The Budding Field of Cannabis Pharmaceuticals
Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.
Coming Up to ISO IDMP Standards
EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.
A Bright Outlook
The outlook for the European pharma industry is appearing to be favourable overall.
The COVID-19 Vaccine Blind Spot
Transparency and open-dialogue are vital to sway the vaccine-hesitant community.
Improving Solubility with Amorphous Solid Dispersions
Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.
Dealing with No Deal
Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.
Calling for Clarity
Industry wants clarification on compliance following the end of the Brexit transition period.
Unique Molecules Push Formulation Boundaries
More complex and challenging compounds require a more tailored approach to formulation strategies.
Masking Taste: A Key Attribute to Success
Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.