Manufacturing roundup: Hikma, Lilly US manufacturing sites hit with 483s; GAO says HHS should address stockpile risks

2022-10-20

细胞疗法疫苗

The FDA has handed down inspection reports to several manufacturing sites in New Jersey, revealing a range of quality control issues.

The 483 inspection report for Hikma Injectables’ outsourcing facility in Dayton, NJ, notes three observationss from an inspection from late May to early June of this year.

The inspection reveals that the “airborne particulate monitoring program for aseptic operations” was not designed to support the quality of drug products meant to be sterile and was not monitoring airborne particulates correctly. The FDA noted on multiple occasions that “particle Counters” were not being directed into the flow of air.

The FDA also notes that some drug products were not properly tested to determine an expiration date, with several products highlighted for not having those results.

Another 483 spells out the inspection details at an Eli Lilly facility in Branchburg, NJ. Several weeks ago, an inspection in July by the US regulator revealed several issues surrounding quality control at the Lilly site.

The two-page report now reveals “unknown debris” in the building and a tank not being “adequately controlled pending satisfactory completion of evaluation by the quality unit.”

The site also failed to document and investigate any deviations from lab procedures. Specifically, the report states that the site did not investigate the impact, root cause, and corrective actions when an Analyst in a redacted QC lab had failed to follow procedure before starting system flow during cleaning.

The Branchburg site has been on the government’s radar for a while, the DOJ slapping it with a subpoena requesting additional documentation on its work in Branchburg. Meanwhile, the whistleblower brought the company to court in New Jersey to seek damages after revealing a wide range of quality control failures dating back to 2018.

HHS should better manage inventory gaps risks within the national stockpile — GAO report

While the HHS has been busy filling the Strategic National Stockpile (SNS) with vaccines to counter recent outbreaks, the Government Accountability Office (GAO) has chimed in on the potential gaps and risks in the SNS.

The report says that from 2015 through 2019, the stockpile used a “multi-step process involving interagency experts, resulting in annual SNS reviews with inventory recommendations,” but stopped when it underwent reorganization. Annual reviews were not completed in 2020 through 2022.

The report states that:

HHS has since completed reviews to inform inventory decisions for fiscal years 2023 and 2024. However, these reviews did not meet most statutory requirements—such as by including the amount of additional medical countermeasures procured— because HHS did not update its procedures to account for changes enacted in 2019. Until HHS updates its procedures, the agency risks not meeting the statutory requirements designed to give Congress additional information about the SNS inventory.

The SNS has been given $5 billion to keep countermeasures on hand for potential anthrax and smallpox outbreaks, and the GAO’s analysis shows that most medical countermeasure types were acquired but often not in the recommended quantities.

“HHS officials noted that gaps in quantities are due to budget constraints and acknowledge these gaps present risks. However, the reviews lack key information needed for managing these risks and communicating them to stakeholders, including to Congress,” the report points out.

While the SNS was granted $6.1 billion in Covid-19 relief funds for supplies for the stockpile that significantly increased the amount of certain medical countermeasures, with most of the funding going toward ventilators and personal protective equipment.

The GAO is making several recommendations to HHS including a review being conducted following statuary requirements, such as “descriptions of the responsibilities of interagency partners.” The GAO also recommends that the assistant secretary for preparedness and response should develop an approach for “ensuring that medical countermeasures under consideration for SNS procurement receive the same consideration regardless of whether they received development funding from BARDA.”

The agency suggests finding a way to manage the risks associated with the gaps between inventory levels and the recommended quantities, and to report risks upon inspection.

WHO reports shortage of Cholera vaccine, recommends a change in strategy

The World Health Organization (WHO) reported that a strained global supply of cholera vaccines forced the hand of the body that manages the emergency supply of vaccines, the International Coordinating Group (ICG).

The organization has suspended the use of two-dose vaccination regimens for cholera and instead will switch to a single dose. This will allow vaccines to last longer while instances of cholera outbreaks have been on the rise according to the WHO with nations such as Haiti, Syria and Malawi experiencing outbreaks this year.

WHO stated that the one-dose approach can be effective although the exact length of the protection is limited and is lower in children.

It is estimated that of the 36 million doses to be made this year, 24 million have been shipped out mainly to react to outbreaks. The ICG has been approved to get an additional 8 million doses. The WHO also notes that manufacturers are working at max capacity but there is currently no short-term solution to boost production.

“The temporary suspension of the two-dose strategy will allow the remaining doses to be redirected for any needs for the rest of the year,” the WHO report said.

Grifols Grifols opens new manufacturing site in Dublin

Plasma medicine manufacturer Grifols Grifols is following in the footsteps of other major pharma on the Emerald Isle and capped off an expansion.

The company reported that it opened a new 183,000-square-foot albumin manufacturing plant in Dublin, adding to Grifols’ presence in its Grange Castle facilities. The site will aim to triple the filling capacity of the production of its “FlexBag” container.

“This new magnificent Dublin manufacturing facility, which incorporates Grifols industry-leading engineering, is indicative of this company’s commitment to investing in essential plasma-medicine infrastructure globally to treat more patients around the world,” said Grifols’ co-CEOs Víctor Grifols Deu and Raimon Grifols Roura, in a statement.

The cost of the expansion and the headcount were not disclosed, but the company invested more than €300 million into its Irish operations since 2012 when it first established a presence there.

Japanese cell therapy startup nets manufacturing partner

A startup in the cell therapy space has netted a manufacturer for its eye disease drug candidate.

Cellusion, a startup centered on using cells to treat disease in the eye, is partnering with the CDMO Minaris Regenerative Medicine to manufacture Cellusion’s candidate CLS001 which is aimed to treat bullous keratopathy, a disease that can cause blindness.

According to the letter of intent, Cellusion and Minaris will develop the manufacturing process of the candidate, with Minaris’ operations in Allendale, NJ, “performing process optimization to meet requirements from the FDA.” Financial details of the deal or a timeline for the product to be finished were not disclosed.

“It is exciting for Minaris Regenerative Medicine to be part of advancing a potential solution to corneal blindness, a widespread need, and we look forward to leveraging our extensive development resources to support Cellusion. We hope to position Cellusion well for its next clinical trial and potentially further support them in their manufacturing needs,” said Minaris CEO Hiroto Bando, in a statement.