Downloads

1. Designing Efficiency Into Your AAV Process 12/2/2020

   To meet your demand for high-quality adeno-associated virus (AAV) now and in the future, you need a scalable and cost-effective way to make it. Adapt this efficient process that we developed by optimizing each step from suspension cell culture to purified bulk.

2. Getting Your Investigational Drug Regulatory Ready 12/1/2020

   You have a new biotherapeutic in development that has shown promise in pre-clinical studies against a life-threatening disease. Affected patients and their providers are anxiously awaiting a new treatment option. How do you get your drug into the clinic quickly? Navigating regulatory requirements can be overwhelming. Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

3. Upstream Platform For Continuous Lentiviral Vector Production 12/1/2020

   Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.

4. Quick To Clinic For Biologics: Fact Sheet 11/25/2020

   The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic program, Thermo Fisher Scientific can deliver your large molecule drug substance for First-in-Human studies in as little as 12 months. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for Biologics is made with speed and flexibility.

5. Bacterial Therapy: Modulation of the Microbiome 11/21/2020

   Dr. Bernat Olle discusses the pioneering work his company, Vedanta Biosciences, is doing to modulate the immune system and provide colonization resistance against infectious pathogens -- particularly those contracted during hospital stays. Learn about a company pioneering the exploration of immune-regulating and immune-potentiating bacteria.

6. Shortening The Timeline To First In Human (FIH) Clinical Dosage Form For Oral / Injectable Delivery 11/13/2020

   Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency. Strategies adopted for a rapid development of a simple yet flexible format proves beneficial.

7. Quantification Of Vector Genomic DNA And Residual DNA In Gene Therapy Vectors Using ddPCR 11/10/2020

   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.

8. Foundations Of Biopharma Finance With Smital Shah, MBA 11/8/2020

   Smital Shah brings a trifecta of chemical engineering, consulting, and finance experience earned at heavyweight companies like JP Morgan, Leerink, and Gilead to her role at clinical-stage RNA therapy biotech ProQR Therapeutics. We sat down for a deep conversation on the recipe for successful business and finance operations in an emerging biopharma organization.

9. Enabling Fast And Appropriate Drug Product Supply For Phase 1 Clinical Trials 10/30/2020

   Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

10. Product Development For An Oral Solid Dosage Using Continuous Manufacturing 10/30/2020

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.