Jill Murphy

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

Novo Nordisk receives the full rights to develop and commercialize the lead program.

Both companies have a focus to developing and commercializing treatments for rare diseases with a strong focus on patients and supporting communities with little to no existing therapeutic options.

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Interpreting data and understanding the various components of biologic drug substance testing is an important skillset to know as a lab personnel.

Twist Bioscience is a synthetic biology and genomics company that has developed a DNA synthesis platform to industrialize the engineering of biology, which is a new method of this process by “writing” DNA on a silicon chip.

The agreement focuses on the research of a targeted allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy, owned by Regeneron, designed to enhance proliferation and potency against solid tumors, according to the press release.

In this episode of Drug Digest, Pharmaceutical Technology editors discuss aseptic processing and manufacturing, including what the future holds in this area and the barriers involved with automated aseptic processing practices.

WuXi XDC will provide end-to-end services to support Boostimmune’s discovery of novel bioconjugates.

The collaboration partner for Willow is focused on more sustainable methods to manufacture intermediates and APIs at reduced cost and less waste, in addition to looking for Willow’s expertise in developing and scaling key ingredients.

The deal is worth up to $36 million with an initial upfront consideration of $14 million, with an additional $22 million in contingent value rights (CVRs) that is payable upon achieving certain milestones.

The expanded operations will also support the start of proline/alanine/serine (PAS)-nomacopan clinical trials in geographic atrophy (GA).

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

Zygel is the first and only pharmaceutically manufactured, synthetic cannabidiol that is formulated as a patient-protected permeation-enhanced gel for transdermal delivery.

The acquisition of the latter includes the company’s lead development asset INV-202, an oral CB1 inverse agonist which is designed to block the receptor protein CB1.

Additionally, Poseida has approved Astellas as a board observer seat, which gives Astellas the right to attend Poseida’s scientific advisory board meetings and certain notice rights related to any potential change of control over Poseida.

The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.

The initial collaboration between the two companies began in 2017 with an extension announced in 2021.

SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).

The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.

BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from this collaboration.

Laboratories are focusing on more automated processes while also trying to maintain an efficient, safe, and personalized experience with each analytical test.

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.

The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.

In this episode of Drug Digest, Pharmaceutical Technology editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective.

The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.

After the completion of the merger, the company is expected to operate under the name “Neurogene Inc."