Supplier News: Catalent, PCI Pharma Services, Sterling Pharma & More By
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Ajinomoto Bio-Pharma Services, PCI Pharma Services, Sterling Pharma, KBI Biopharma, Selexis, Wheeler Bio, and VintaBio.
* Catalent Provides Business Update; Names Interim CFO
Chemicals/Chemical API Manufacturing
* Sterling Pharma Gets OK from UK Regulatory Authorities for ADC Mfg
* KBI Biopharma, Selexis Name New CEO
* Wheeler Bio Raises $31 M To Support Funding New Biologics Mfg Facility
* Vintabio Opens New Cell-, Gene-Therapy Mfg Facility; Raises $64 M; Names CEO
Formulation Development/Drug Product Manufacturing
* PCI Pharma Adds Sterile Fill-Finish Capacity at Two Facilities
* Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line
Catalent Provides Business Update; Names Interim CFO
Catalent has provided a business update and appointed a new Interim Chief Financial Officer (CFO), as announced in a statement issued on April 14, 2023. Although complete financial information and operating data for the company’s third fiscal quarter ended March 31, 2023, are not yet finalized, the company expects that productivity issues and higher-than-expected costs experienced at three of its facilities, including two of its largest manufacturing facilities, during the quarter will materially and adversely impact the company’s financial results for the third fiscal quarter and its outlook for the remainder of the 2023 fiscal year.
One of the facilities that experienced productivity issues is the company’s gene-therapy manufacturing site in Harmans, Maryland (its site near the BWI airport), where the company’s plans to increase capacity for a customer’s product during the third quarter to ramp production was slower than expected. During this ramp-up, certain operational challenges, including those related to the initial deployment of a new enterprise resource planning (ERP) system, significantly reduced the expected revenue in the third fiscal quarter associated with the site and will also impact revenue previously expected in the fourth quarter.
Catalent reports that the timely resolution of these issues was delayed by the necessity of focusing site resources on important regulatory inspections involving the BWI site, which were successfully completed. The ERP-related challenges were operational in nature and will not impact the company’s ability to produce timely and accurate financial statements. None of these issues is expected to adversely impact the quality or commercial launch quantities of any product made at the BWI site in light of, among other things, the level of “bright stock” on hand. However, revenue from unproduced batches cannot be made up for in this fiscal year due to manufacturing capacity constraints. The company expects to recover related revenue in the second half of calendar year 2023 (the first half of the company’s 2024 fiscal year).
In the fiscal third quarter, Catalent said it also experienced productivity challenges and higher-than-expected costs at its drug-product and drug-substance manufacturing facilities in Bloomington, Indiana, and Brussels, Belgium, where the company was unable to achieve anticipated productivity levels and associated revenue due in part to the continued need to implement enhancements to its operational and engineering controls following regulatory inspections that occurred earlier in the fiscal year. While these issues are also expected to affect the company’s fiscal fourth quarter to end on June 30, 2023, productivity levels in Bloomington are expected to be restored to previously forecast levels in that quarter. As with the BWI site, the company does not expect to make up for the lost production at Bloomington until after the close of the current fiscal year.
After conducting an internal review of the company’s manufacturing operations, the company has taken a number of measures at its BWI, Bloomington, and Brussels sites, including both management and operational changes, to address the root causes of the issues identified at each site.
Additionally, Catalent has announced that Ricky Hopson, who had been serving as the President and Division Head for Clinical Development & Supply at Catalent, will assume the role of the company’s Interim Chief Financial Officer, effective April 14, 2023, following the departure of Thomas Castellano as the company’s Senior Vice President and Chief Financial Officer on April 13, 2023.
Hopson has served as President and Division Head for Clinical Development & Supply since July 2022. Prior to that, he served the company for more than 20 years in a variety of finance roles, most recently as the company’s Vice President & Chief Accounting Officer since June 2021. Prior to that, Hopson served was the company’s Vice President & Corporate Controller, Global Vice President, Operational Finance, and Vice President of Finance for two different business units.
Chemicals/Chemical API Manufacturing
Sterling Pharma Gets OK from UK Regulatory Authorities for ADC Mfg
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s pharmaceutical regulatory authority, has granted manufacturer’s authorization for investigational medicinal products to Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates. The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its cGMP manufacturing facility in Deeside, UK.
Sterling acquired the 6,500-square-meter site as part of its purchase of ADC Biotechnology in April 2021, and has since gone on to invest in expanding the facility to develop its scientific and analytical teams, install a new water-for-injection plant, and establish bioconjugation and ADC manufacturing capabilities. The license allows for GMP bulk drug-substance manufacture to support all phases of clinical studies, GMP release testing, and stability studies. The site will work in parallel with Sterling’s facility in Germantown, Wisconsin, which provides services to develop and manufacture highly potent small molecules that make up part of an ADC drug molecule.
Source: Sterling Pharma Solutions
KBI Biopharma, Selexis Name New CEO
KBI Biopharma, a Durham, North Carolina-headquartered biologics CDMO, and Selexis, a Geneva, Switzerland-based provider of mammalian cell-line generation technology, have announced the appointment of J.D. Mowery as the companies’ CEO. Both companies are part of JRS Life Sciences.
Mowery previously worked for both bio/pharma companies and CDMOs. His experience includes roles with Roche’s Genentech, Celgene, Juno Therapeutics, and most recently, Treadwell Therapeutics, a New York-based bio/pharmaceutical company, as well as CDMOs, including Lonza and AGC Biologics.
Source: KBI Biopharma and Selexis
Wheeler Bio Raises $31 M To Support Funding New Biologics Mfg Facility
Wheeler Bio, an Oklahoma City, Oklahoma-based biologics CDMO, has raised $31 million, which will be used to complete its cGMP cell-banking and drug-substance manufacturing facility (500-L scale) in the Ziggurat, a downtown Oklahoma City office tower. The first cGMP production batches in the new facility will begin in the third quarter of this year (2023).
Source: Wheeler Bio
Vintabio Opens New Cell-, Gene-Therapy Mfg Facility; Raises $64 M; Names CEO
VintaBio, a CDMO of viral vectors for cell and gene therapies, has raised $64 million to support its investment for a new manufacturing facility in Philadelphia. The now-open 22,500-square-foot Philadelphia facility is designed specifically to streamline cell- and gene-therapy development and manufacturing.
In addition, the company has named David Radspinner, most recently President of the biotherapeutics portfolio of ILC Dover, an engineering development and manufacturing company, as the company’s CEO. Previously, he was Vice President of the Americas at Cytiva. He also worked at Eli Lilly & Company and Sanofi, developing analytical methodologies, drug products, and processes.
Formulation Development/Drug Product Manufacturing
PCI Pharma Adds Sterile Fill-Finish Capacity at Two Facilities
PCI Pharma Services, a Philadelphia, Pennsylvania-based CDMO of drug products and contract packager, has announced that three new automated sterile fill–finish machines at its San Diego, California, and Melbourne, Australia, facilities are now fully operational.
Source: PCI Pharma Services
Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line
Ajinomoto Bio-Pharma Services, a San Diego, California-based CDMO of active pharmaceutical ingredients (APIs) and drug products, has announced that the US Food and Drug Administration (FDA) has approved the company’s high-potency vial line to manufacture a commercial product.
The company has six fill–finish lines in San Diego, including a new line that offers a range of configurations, including prefilled syringes, cartridges, and vials. The high-speed process is rated to move up to 22,000 syringes per hour through the line, with a batch capacity of over 200 thousand syringes.
Source: Ajinomoto Bio-Pharma Services