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Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Increasing product yield is the most fundamental way to achieve this.

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Optimising biopharma production through process intensification

Pharmaceutical Technology

Process intensification can loosely be described as making more product with the same or fewer resources. The appeal of process intensification continues to grow in the biopharma industry as a means of not only increasing the productivity, but also improving sustainability. Existing technologies could also be run in a different way.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose.

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Roche’s Herceptin/Perjeta combo product nears EU approval

pharmaphorum

Called Phesgo , the new product contains the active substances in Herceptin (trastuzumab) – already facing lower-cost competition in the US and Europe – and Perjeta (pertuzumab), which are both used to treat HER2-positive breast cancers. The post Roche’s Herceptin/Perjeta combo product nears EU approval appeared first on.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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ASP-2138 by Xencor for Metastatic Adenocarcinoma of The Pancreas: Likelihood of Approval

Pharmaceutical Technology

The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 Xencor overview Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases.

Antibody 100
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ASP-2138 by Xencor for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 Xencor overview Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases.

Antibody 100