Tuesday, June 8, 2021 Daily Archives

How to Optimize Final Filling in Bioprocessing

This webcast features: Andeka Ocio Velasco, Manufacturing & Process Validation Technician, Progenika Biopharma, a Grifols company; and Robert Martindale, Product Sales Manager, Masterflex EMEA, Antylia Scientific The final filling mistakes within bioprocessing are far too expensive to be allowed or tolerated. Continuous optimization is a commitment that all companies need to embrace to increase business profitability potential. Evaluating and utilizing new technologies will enable a faster methodology of process, increase the scaling up of bioprocesses, and increase the accuracy of…

Improving the Bioavailability of Challenging APIs using Hot Melt Extrusion with Polyvinyl Alcohol

New molecular entities (NMEs) are becoming larger, more crystalline and more lipophilic and, as a result, less soluble. While approximately 40% of active pharmaceutical ingredients (APIs) currently on the market show poor solubility, it is estimated that between 60 and 90% of compounds in development have solubility challenges.1,2 For an oral formulation, API solubility and permeability are critical factors for absorption in the gastrointestinal tract. As a result of this, solubility-enhancing formulation techniques have become an area of focus for…

Evaluating Current Manufacturing Platforms for Viral Vector Production to Enable Gene Therapy Products

The rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral vector manufacturing platforms to deliver these therapies. Adeno-associated virus (AAV) has become the vector of choice as it stands out for its safety profile since infection with the vector is not pathogenic. Also, AAV cannot replicate on its own and is not directly integrated into the host genome. Realizing the full potential of viral vector-based therapies requires a successful manufacturing platform for…

What Technologies Should You Apply to Your Vaccine-Specific Process?

Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, there are also many vaccines. They can be classified by antigen character, but the manufacturing flows used to produce them are relatively similar. Read now our Vaccine Bioprocessing Handbook to learn more on similarities and differences on Vaccine processes for: viral vaccines, Virus-Like Particle (VLP) Vaccines, Polysaccharide Conjugated Vaccines, Viral Vector Vaccines…

Ins & outs: CureVac names new chief development officer

CureVac has named Klaus Edvardsen as its chief development officer. Meanwhile, there are changes at Gamida Cell and AavantiBio. Sit back, relax, and enjoy BioProcess Insider’s Ins & outs. Up first in this week’s Ins & Out’s we have mRNA firm CureVac, which has appointed Edvardsen as chief development officer effective from August 1, 2021. “We are very pleased that Klaus is joining us in highly dynamic times for the company,†said Franz-Werner Haas, CEO of CureVac. “He brings a wealth of…

Industry consortium takes aim at lowering CGT production costs

GSK, Cytiva, and Lonza are among 20 companies looking to develop technologies aimed at lowering the cost of cell and gene therapy production. Over 20 companies have been brought together by the Cell and Gene Therapy Catapult (CGT Catapult) to assess multiple process analytical technologies (PAT), which are new or frequently used in other sectors. This is the first consortium of this scale with the 20 companies consisting of technology providers, therapy developers, charities, and pharmaceutical firms. The consortium has…

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…