Manufacturing roundup: Societal CDMO nets new customers; Chime Biologics gets the OK to manufacture antibodies
Societal CDMO has been awarded service contracts for three new customers. The agreements include an array of manufacturing services, for clinical trials, analytical methods, formulation development and cGMP manufacturing.
For the first contract, Societal will support the initiation of a Phase II clinical study of an antidepressant already approved for use in Europe and Australia. Societal will be responsible for sourcing, preparing, packaging and labeling of both the study drug and matching placebo for use in the trial. These activities will be conducted in collaboration at its facilities in Georgia and California.
In addition, Societal will help develop a liquid oral formulation, and then produce and package an initial batch, of an investigational treatment for pediatric patients with dietary restrictions who also have neurological and neuropsychiatric diseases.
And in the third contract, Societal will support another clinical trial — a Phase II study of an antisense oligonucleotide being tested in various cancers. Societal will label, store and distribute the candidate as part of the contract.
“These new agreements spotlight the full range of services that Societal CDMO provides its customers, starting with efforts in the areas as analytical method and process development, as well as formulation design, and advancing into cGMP manufacturing, packaging, labeling, and distribution. Importantly, two of these new agreements involve our clinical trial services business, which we view as a key driver of growth for the company,” said Societal CDMO’s CEO David Enloe in a statement.
Chime Biologics receives a Chinese manufacturing license
Chime Biologics, which netted investor cash in 2021 for a 15x manufacturing expansion, has received a commercial manufacturing license from the National Medical Products Administration (NMPA) in China.
According to the company, after an 18 month product development and manufacturing collaboration with LEPU Biopharma, the company passed a pre-approval inspection, including an on-site inspection and GMP compliance inspection.
Under the partnership with LEPU Biopharma, Chime will manufacture an anti-PD-1 monoclonal antibody dubbed Puyouheng, which has been conditionally approved for marketing in China. The drug is approved for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient (dMMR) advanced solid tumors.
“This also marks the official entry of Chime Biologics into the era of commercial production service. Chime Biologics will work with Lepu side by side to provide alternative medical solutions to cancer patients in China and the rest of the world,” said Chime CEO John Zeng in a statement.
Teva hits supply snag for its ADHD medication Adderall
Teva has hit a bump with its popular ADHD drug Adderall.
According to the American Society of Health-System Pharmacists (ASHP), both 20mg and 30mg tablets of Adderall are currently on backorder in the US, as the company is eyeing a release date later this month. The FDA drug shortage tracker doesn’t note a current Adderall shortage. According to it, an Adderall shortage has previously been resolved, but the site also warns that its database is experiencing technical difficulties and may be out-of-date.
The ASHP said Teva is experiencing backorder issues with its generic version of Adderall as well. However, the company is expected to release more 10mg generic tablets in August, followed by 15mg and 30mg tablets.
For Adderall, Teva is aiming to release more 20 mg and 30 mg tablets in early- to mid-August, ASHP said.