INSIGHTS ON DRUG DEVELOPMENT
Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start
As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.
What You Need To Know About Process Characterization And Validation For Biologic Processes
Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.
Sponsor Challenges When Outsourcing Sterile Injectables
ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.
Expanding SPR Uses In Antibody Effector Function Determination SPR can be implemented at early stages in screening and testing strategies in order to provide better, faster, and stronger analysis of drug candidates. In order to minimize risk and to get “true” affinity in binding analysis, we have adopted the latest innovation in surface plasmon resonance (SPR) technology, Biacore™ 8K, to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision.
Novel Analytics To Improve Bioprocessing And Validation Guideline Review
A thorough understanding of how the process impacts the product quality attributes is essential for decision-making. Implementation of a robust analytical control strategy with information-rich technologies has the potential to significantly improve characterization and productivity. This presentation will provide an overview of how innovative protein analysis tools have been adopted for better comparability, release testing, and impurity monitoring.
The Physical Properties Of An API And Drug Product Performance
An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.
Streamlined High Performance Extraction And Quantitation Of Host Cell Residual DNA In Bioproduction
Residual host cell DNA is a common process-related impurity that is typically co-monitored with host cell protein. Here we report on high performance Host Cell Residual DNA extraction and quantitation using a streamlined and high throughput semi-automated workflow.
Leveraging Media And Supplements For Desired Protein Glycosylation
Obtaining desirable and consistent monoclonal antibody (mAb) protein quality attributes, such as glycosylation, is critical in today’s bioproduction industry, especially for biosimilar molecules. This poster highlights a case where we use high throughput screening (HTS) to evaluate mAb production and glycosylation for a Chinese hamster ovary (CHO) cell line in a chemically defined (CD) media panel.
DRUG DEVELOPMENT SOLUTIONS
Biacore™ Insight Evaluation Software
Biacore Insight Evaluation Software offers a modular evaluation software with intuitive workflow and application-specific extensions, tailored for Biacore systems. The modular design of the software extensions allows a more cost-efficient configuration to evaluate data from surface plasmon resonance (SPR) systems including Biacore 8K, Biacore 8K+, Biacore T200, and Biacore S200.
Zydis® Fast Dissolve Technologies - Effective Dose Forms For Pediatric Health
Patient compliance with medication can be a complex problem and especially challenging for pediatric populations.
Zydis® fast dissolve formulations are an effective solution through extremely rapid dispersion in the mouth and the smooth, pleasant taste. Patient acceptance of Zydis formulations is especially high in paediatric populations, demonstrated by 50% of medications currently formulated in Zydis Orally Disintegrating Tablets (ODT) being specifically indicated for use with children.
The demand for biopharmaceutical products is continuously growing to serve the needs of an aging global population and the prevalence of chronic diseases. At the same time, the environment for biopharma companies is complex and challenging, with novel regulatory pathways, requirements to accelerate patient access, and rising competition.
Biologics Fact Sheet
The challenges, risks and costs of bringing complex large molecule products to market are growing exponentially. Gaining a competitive advantage is more difficult. Drawing on 20 years of biologic experience, Thermo Fisher Scientific offers you flexible end-to-end solutions and expertise in development and manufacturing
Surfactant Analysis Services
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
FEATURED OUTSOURCING EDITORIAL
Implementing an Effective CAPA System
April 10, 2020
Writing Excellent SOPs
April 10, 2020
Medical Device Recalls – Keys To Implementing A Successful Approach
April 14 - 14, 2020
1pm-2:30pm EST, Online Training Duration: 90 Minutes
Price: $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response
April 15 - 15, 2020
1pm-2:30pm EDT, Online Training Price: $299 - Includes Bonus Handouts!
Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities
April 16 - 16, 2020
1pm-2:30pm EDT, Online Training Duration: 90-Minutes
Price: $199 - Includes Bonus Handouts!