Biologic Drugs

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Further advances in construct design and manufacturing scalability are still needed.

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

NIH has announced four new grant awards to fund new tuberculosis research advancement centers.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

PharmTech interviewed Sartorius about SUS innovations and trends.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

Workforce training is crucial for biopharmaceutical manufacturing.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

Controlling conditions and preventing contamination are crucial for cell growth.