Pharmaceutical Technology Editors

Thermo Fisher Scientific announced that their manufacturing site in Greenville, NC, was recognized with the 

 Best Plants Award. The award recognizes North American manufacturing facilities for excellence in factors such as productivity, customer care, and employee engagement.

The Greenville site is a multi-purpose pharmaceutical manufacturing and packaging campus that is more than one million square feet. It provides both sterile and oral solid manufacturing services from the early development stage to the commercial phase. It also provides liquid and lyophilized fill/finish manufacturing services and supply packaging for therapies and vaccines.

This is the fourth time Thermo Scientific has been recognized. Previously, it’s sites in Auburn, Ala., Asheville, NC, and Marietta, Ohio have been recognized. All winners will be recognized at the Manufacturing & Technology Conference, November 9–11, 2021, in Cleveland, Ohio, at the Huntington Convention Center

 Best Plants Award to Thermo Fisher Scientific's Greenville site in North Carolina,” said Jill Junko, executive editor and director of the IndustryWeek Best Plants Awards program, in a Thermo Fisher press release. “It admirably displays what we seek among winners: engaged leaders and team members, solid evidence of operational excellence, and a continuing commitment to continuous improvement."

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Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

Thermo Fisher Scientific Named IndustryWeek Best Plants Award Winner 2021

Syngene International, a contract research and development (CDMO) organization, announced that they have set up and commissioned two expansions to their facilities in Bengalaru, India. One is a new microbial facility, while the other is an expansion to their existing mammalian facility.

The new microbial facility has two fermenters that hold 200 L and 500 L volumes and will provide further integration opportunities with the company’s existing discovery and development capabilities, which will extend the company’s service offerings in good manufacturing practice (GMP) manufacturing of plasmid DNA and messenger RNA (mRNA).

An additional single-use 2000-L bioreactor will be added to the mammalian manufacturing facility, which is compliant with FDA and European Medicines Agency regulations, according to the company in a press release. This expansion builds on Syngene’s existing biopharmaceuticals manufacturing capability and is expected to strengthen their services for commercial supply.

“The recent investments have increased our production capabilities for bulk drug substance to meet the growing requirements from our expanding client base for end-to-end [C]GMP [current good manufacturing practice] clinical and commercial manufacturing.”said Jonathan Hunt, CEO and managing director of Syngene International, in the press release.“Use of digitalization and automation tools [such as] electronic quality records and digital signatures will not only help avoid the risk of human errors, but also decrease operational costs and improve time-to-market.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Syngene Expands Microbial and Mammalian Manufacturing Facilities in Bengalaru

CureVac and GSK announced that their second-generation mRNA COVID-19 Vaccine, CV2CoV, had demonstrated improved immune response and protection in a preclinical study.

The study assessed cynomolgus macaques immunized with 12µg of either their first-generation vaccine candidate, CVnCoV, or the second-generation vaccine candidate. Adaptive immune responses were assessed through receptor binding domain specific antibodies and neutralizing antibodies as well as memory B and T cells.

The study found that the group given the second-generation vaccine candidate had a faster response onset, higher titers of antibodies, and stronger memory B and T cell activation relative to the other group. Additionally, there was a higher antibody neutralizing capacity across all selected variants (Alpha, Beta, Delta, Kappa, and Lambda).

CureVac and GSK announced their collaboration in February 2021, which focuses on the development of new products based on CureVac’s second-generation mRNA technology. A Phase I clinical trial is expected to start in Q4 2021.

“In this animal model, CV2CoV is shown to induce broad antibody and cellular immune responses very similar to the breadth of the immune responses observed after infection with SARS-CoV-2,” said Igor Splawski, chief scientific officer of CureVac in a company press release. “The current study shows that the immune responses and resulting protection produced by our second-generation candidate, based on our mRNA technology featuring targeted optimizations, are substantially improved in non-human primates against both the original SARS-CoV-2 virus as well as the Beta and Delta Variants of Concern and the Lambda Variant of Interest.”

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

GSK and CureVac’s Second-Generation mRNA COVID-19 Vaccine Candidate Shows Promising Results in Preclinical Study

FDA has approved Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia (IH) in adults. Xywav was previously approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy. This is the first approval FDA has granted to IH, an uncommon sleep disorder that causes one to become excessively sleepy throughout the day even after a good night’s sleep.

A double-blind randomized-withdrawal study consisting of 154 adults aged 19–75 was done where applicants were randomized to switch from Xywav to a placebo. It found that those switched to a placebo experienced worsening of measures related to sleepiness and symptoms of IH compared to those who stayed on Xywav.

The drug’s active moiety is oxybate, also known as gamma-hydroxybutyrate (GHB), which is a Schedule I controlled substance. Known side effects include seizures, trouble breathing, changes in alertness, coma, and death. Because it is a Schedule I controlled substance, it falls under strict safety protocols. It can only be prescribed by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. It will not be available in retail pharmacies.

FDA granted Xywav Fast Track and Priority Review designations. It was also given an Orphan Drug Designation, which provides additional incentives for treatments intended for rare conditions.

“A novel indication for Xywav is significant as the FDA has never granted an approval for idiopathic hypersomnia,” said Eric Bastings, deputy director of the Office of Neuroscience in FDA’s Center for Drug Evaluation and Research. “Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder.”

FDA has granted its first approval for an idiopathic hypersomnia treatment.

FDA Grants First of its Kind Indication for Idiopathic Hypersomnia Treatment

FDA has opened a public docket to solicit comments on issues relating to FDA post-approval regulation of drug products that were approved under abbreviated new drug applications (ANDAs) before the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments), which established the current ANDA process.

Since 1938, drug approvals were regulated through the FD&C Act, but in 1984, the Hatch-Waxman Amendments added sections 505(b)(2) and 505(j) to the FD&C Act, which introduced the current pathways for new drug applications (NDAs) and ANDAs, respectively.

Because ANDAs approved between 1938 and 1984 (PANDAs) were implemented without the Hatch-Waxman Amendments in place, the rules surrounding their regulation differ from contemporary ANDAs. This difference has led to questions surrounding how to best handle PANDAs, which have historically been overseen by FDA’s Office of Generic Drugs, in relation to contemporary ANDAs.

For example, because PANDAs were instituted before the Hatch-Waxman Amendments and were submitted under Section 505(b) and approved under Section 505(c), they can serve as a reference listed drug (RLD) for generic drugs submitted as an ANDA or NDA. According to the FDA docket, this has led to “some confusion about the applicability of certain statutory and regulatory provisions” among applicants.

FDA will solicit feedback from interested parties until December 13, 2021. For more detailed submission guidelines, you can view their guidelines 

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

FDA Solicits Comments on Drug Products Approved Ahead of Hatch-Waxman Amendments

Terumo Blood and Cell Technologies, a medical device company, and PhotonPharma, a cancer immunotherapy developer, announced in an August 11, 2021 press release a memorandum of understanding (MOU) for collaboration to develop innocell, a novel tumor-specific immunotherapy for solid tumors.

The MOU/initial agreement details the following:

PhotonPharma will use Terumo's mirasol pathogen reduction technology in the manufacturing process to develop cancer immunotherapy.

PhotonPharma is authorized to reference the device master file on record with FDA for the Mirasol system, which will support PhotonPharma’s regulatory submission for innocell.

Terumo Blood and Cell Technologies is to supply mirasol illuminators and single-use sets for the preparation process of the immunotherapy used in the clinical trial.

Since 2007, Terumo's mirasol has been used in select markets outside the United States. It was designed to reduce pathogen load and inactivate residual white blood cells in whole blood and blood components.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.