INSIGHTS ON CONTRACT PHARMA MANUFACTURING
Benefits Of 5KL Bioreactor When Outsourcing Late-Phase Biologics Drug Substance Manufacturing
Watch this webinar today to discover how Thermo Fisher Scientific is addressing and overcoming two critical, current challenges in upstream bioprocessing.
Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies
This webinar covers the key considerations for formulation screening of therapeutic proteins with a focus on maintaining protein stability and avoiding aggregation.
The Art and Science Of Tech Transfer – Transferring Vaccine Production
As COVID 19 vaccine development and manufacturing has rightfully become a global priority, it has left other vaccine producers and public health organizations searching for manufacturing capacity. Facilities committed to COVID 19 production are forcing non-COVID 19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case.
Saving Development Time With A Single Vendor Approach
This webinar provides an overview of Thermo Fisher Scientific’s Quick to CareTM program. Watch it to learn how a single-vendor with a cohesive global network can help you accelerate the drug development process and reach the market sooner.
Vaccine Capacity Musical Chairs
In the past six months, I’ve spoken to more vaccine developers than I have in the previous eight years, all of them searching for production capacity. With the good news from Pfizer, Moderna, and many other organizations completing their clinical trials and vaccine production, and distribution being maybe only weeks away, does this mean the music has stopped and it is time to grab a chair?
Art And Science Of Tech Transfer — Establishing The Path For Success
Pharmaceutical technology transfer often invokes images of a complicated set of activities required to transfer the development and manufacturing of a product, or products, from one facility to another. This article shares five features of a successful tech transfer, imperatives that we have learned with a focus on drug sponsors working with CDMOs. These imperatives, when applied to project management operations, can deliver extraordinary results.
Residual Host Cell DNA Quantitation: In-House Vs. Commercial
Here, we illustrate approaches for analytical method development and the challenges that may be encountered, particularly in the development of a quantitative assay for residual host cell DNA.
Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors
Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.
Sterile Parenteral, Aseptic Fill-Finish, Helping You Take Your Drug from Concept To Clinical To Commercial
Pii can provide you with the state-of-the-art GENiSYS R aseptic filling and closure system. The GENiSYS R aseptic filling and closure system is a fully robotic, automated line providing accurate precision-filling and eliminating the loss of costly drug product.
CONTRACT PHARMA MANUFACTURING SOLUTIONS
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.
Light Path™ Custom Material Supply: Mammalian And Microbial Custom Services For Protein Production
At Lonza, we understand the challenges facing biotherapeutic and vaccine manufacturers related to the time and costs inherent in the drug discovery and development process. Light Path™ Custom Material Supply Services are efficient, focused technology and production offerings for the Preclinical and Phase I stages of novel biologics development.
Singota Solutions – Your CDMO Focused On Faster
Do you need a contract development and manufacturing organization (CDMO) that will fill the gaps in the drug development process and focus on getting patients the treatments they need faster? Read how the team of experts at Singota is here to collaborate with you, customizing our services to meet your needs and hit your milestones.
IDT Biologika - A Viral Vaccine And Viral Vector CDMO
IDT Biologika provides contract development and manufacturing of live viral vaccines, gene and immune therapeutics, and fill/finish of biologics.
OnTheGoSM Services Fact Sheet
OnTheGoSM is a PDMA-compliant suite of mobile/web apps that optimize sales representative productivity and enhance practitioner convenience and service. They complement the Patheon, by Thermo Fisher Scientific specialty logistics sample distribution service offering by providing Sales Representatives and Managers with enhanced capabilities.
FEATURED OUTSOURCING EDITORIAL
Personal Protective Equipment Requirements
January 18, 2021
Hazardous Material Release Reporting Requirements
January 25, 2021
DCAT Sharp Sourcing Webinar: Pharma’s Manufacturing and Supply Lines:
January 26, 2021
How to Conduct a HIPAA Risk Assessment
February 4, 2021
HIPAA, 42 CFR Part 2, and FERPA - Rules for Managing Student Health Information
February 9, 2021