A roundup of manufacturing news from Biocon Biologics, Orca Bio, and Medigen. Highlights below.

* Biocon Receives Form 483s from FDA
* Orca Bio To Build Cell-Therapy Mfg Facility
* Medigen Expanding Vaccine Mfg & Operations

---

Biocon Receives Form 483s From FDA
The US Food and Drug Administration has issued Form 483s to Biocon Biologics, a Bangalore, India-based bio/pharmaceutical company following three onsite inspections of seven manufacturing facilities spanning two sites in Bangalore, India, and one at Johor, Malaysia. These inspections started with the Bengalore site on August 11, 2022, and concluded with the Malaysia site on August 30, 2022. The agency issued Form 483s with 11 observations each for the two sites in Bangalore and six observations for the site in Malaysia.

The inspections were triggered on account of three preapproval inspections for biosimilars of bevacizumab, rh-insulin, and insulin aspart, and a capacity expansion inspection for a biosimilar of trastuzumab. These included multiple drug-substance and drug-product facilities and other support infrastructure at these sites.

The observations primarily relate to the need for the following: improving strategies for microbial control; enhancing quality oversight; augmenting the use of software applications and computerized tools to aid risk assessment and investigations; and other procedural and facility upgrades.

The company says it will submit corrective and preventive action plans (CAPA) to the FDA in the stipulated time frame. “We do not expect the outcome of these inspections to impact the current supply of our products,” said the company in an August 31, 2022 statement.

Source: Biocon Biologics

---

Orca Bio To Build Cell-Therapy Mfg Facility
Orca Bio, a Sacramento, California-based clinical stage bio/pharmaceutical company of cell therapies, has announced plans to construct a new 100,000-square-foot commercial manufacturing facility in Sacramento, California. The facility will support the late-stage clinical development and commercialization of Orca Bio’s cell therapies, including Orca-T, which is currently being evaluated in a Phase III registrational trial.

The facility will have capacity to manufacture approximately 3,000 cell therapy products and is located in proximity to Orca Bio’s existing clinical manufacturing building. It will have modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space, and offices. The construction began in August of 2021 and is scheduled to be completed later this year (2022). The facility is expected to be fully validated and operational in the first half of 2023. 

Source: Orca Bio

---

Medigen Expanding Vaccine Mfg & Operations
Medigen, a Frederick, Maryland-based vaccine company, is doubling its leased space at its site in Frederick to 12,000 square feet for its vaccine development and operations. The expansion will space to increase its manufacturing workforce, with the additional space expected to be used for the company’s vaccine development and operations as well as contract manufacturing services.

Source: Medigen