This week’s biotechnology news headlines include, GSK and Novartis complete deals, 2015 to be strong year for biotech, Bristol-Myers lung cancer drug approved, testing for gene editing therapy for HIV gets ok from FDA, AbbVie to buy Pharmacyclics, biosimilar labeling guidance, and Novartis wet AMD drug meets PII targets.
Cell Culture Events
March 25, 2015
Learn the key bioprocess economic parameters to be considered when designing the manufacturing strategy for an adherent cell-based allogeneic product.
Developing the right industrialization strategy is critical to support a sustainable Cell Therapy development and commercialization program. Cell sources, stock management, and technology performance are some of the key parameters that determine the manufacturing scale required for specific product characteristics, supply chain, and business risk management.
Participants will learn:
- Map the factors influencing your bioprocess scale.
- Design optimized manufacturing strategies for allogeneic cell-based therapies.
- Evaluate and select the most cost-effective technology according to the lot size.
- Align process development to the product roadmap.
March 10-13, 2015
One of our most popular workshops, this Cell Culture Workshop covers essential fundamentals, providing a solid basis for the understanding of the growth of animal cells. We combine lecture and laboratory exercises aimed at giving participants a deeper understanding of serum-free media applications and related topics.
Topics include: Introduction to cell and tissue culture, serum containing media and the use of serum. cell counting and viability determination, development of growth curves, growth of adherent and suspension cells, transfection technologies for recombinant protein expression in animal cells, cryopreservation and cryothawing of animal cells, cell cloning , primary cell culture and so much more.
Genome Editing Applications – March 18-19, 2015 – Hilton Boston Back Bay, Boston MA
Biopharmaceutical Development and Production Week – March 30-April 2, 2015 – Hyatt Regency Huntington Beach Resort and Spa, Huntington Beach, CA
Co-located with Single-use Applications and Flexible Facilities
“GlaxoSmithKline and Novartis said on Monday they had completed a series of asset swaps worth more than $20 billion that will reshape both drugmakers.”
If you like this story, please see our blog titled “The Benefits of Implementing Bioprocess Monitoring and Quality by Design in Process Development”
“The biotech sector is poised to continue on its sharp growth trajectory, coming off of a year that saw some 34% of growth through 2014 and more than 300% growth over the last five years. Remedies for conditions like hepatitis C, NASH and oncology will all help drive growth in this sector, noted Asthika Goonewardene, senior biotechnology analyst for Bloomberg Intelligence.”
If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”
“U.S. health regulators on Wednesday swiftly approved a Bristol-Myers Squibb Co drug that helps the immune system fight the most common form of lung cancer, sending the company’s shares up more than 5 percent to a multi-year high.”
If you like this story, please see our blog titled “Developing Ebola Vaccine and Securing Your Cold Chain Logistics Plan”
“Researchers received the go-ahead from federal regulators to test a gene-editing technique in humans that could jam a doorknob used by the AIDS virus and produce a “functional cure” for the disease.”
If you like this story, please see our blog titled “Materials and Assay Systems Used for 3D Cell Culture”
“AbbVie Inc (ABBV.N) is to buy Pharmacyclics Inc (PCYC.O) for about $21 billion, giving it access to what is expected to be one of the world’s top-selling cancer drugs and expanding its reach in the profitable oncology field.”
If you like this story, please see our blog titled “Reprogramming Blood Cells: How to Decrease Variability in Your Workflow”
“With US’ First Biosimilar Approval Expected This Week, is FDA’s Biosimilar Labeling Guidance Imminent?” Regulatory Focus
“The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US’ first biosimilar, Sandoz’ Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there’s a good chance the biopharmaceutical industry won’t have to wait long for the release of that guidance.”
If you like this story, please see our blog titled “The Evolution of Vaccine Manufacturing – Past, Current, and Future Trends”
“Mid-stage data assessing Novartis’ eye drug RTH258 indicates that it could be an effective option for treating wet age-related macular degeneration, with the added bonus of less frequent dosing than Regeneron/Bayer’s Eylea (aflibercept).”
If you like this story, please see our blog titled “Intestinal Organoid Culture: a Convenient and Physiologically Relevant Model for Intestinal and Stem Cell Research”