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Pfizer vaccine has good results in adolescents; More vaccine capacity announced

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Emergent BioSolutions agreed with an FDA request that the company not initiate manufacturing of new drug substance for COVID-19 vaccines and to quarantine existing material manufactured at the company’s Bayview, Md., facility. Production is halted pending the completion of an FDA inspection and any required remediation, according to Emergent’s 

 with the US Securities and Exchange Commission (SEC).

Emergent reported that it agreed to the halt in manufacturing on April 16, 2020; FDA initiated an inspection of the facility on April 12, 2021. The inspection follows the announcement of a manufacturing error at the Bayview facility that led to the loss of 15 million potential doses of Johnson & Johnson’s COVID-19 vaccine.

that it assumed responsibility for manufacturing the drug substance for its live viral vector vaccine at the Bayview facility.

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Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility. 

Emergent BioSolutions Pauses Vaccine Manufacturing 

Pfizer and BioNTech announced on April 19, 2021 that they will supply an additional 100 million doses of their COVID-19 vaccine, COMIRNATY, to the European Union (EU) member states in 2021.

The additional doses are a result of the European Commission’s (EC) expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million, Pfizer said in a company press release.

“We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the European Union in Q2 [second quarter], a four-fold increase on Q1’s [first quarter’s] agreed quantity.”

“The additional 100 million doses from this option exercise will further help to support the acceleration of the vaccination campaigns throughout the EU. We now intend to deliver a total of 600 million doses to the EU this year, which covers two thirds of the EU population and represents the largest cumulative supply agreement for COMIRNATY that we have agreed to date globally,” added Sean Marett, chief business and chief commercial officer, BioNTech, in the press release.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

Pfizer and BioNTech to Supply EU with 100 Million Additional COVID-19 Vaccine Doses

 on April 16, 2021 that it has revoked the Emergency Use Authorization (EUA) for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. The decision was based on analysis of scientific data that included a look at SARS-CoV-2 variants that appear to be resistant to bamlanivimab alone. This resistance, according to FDA, resulted in an increased risk of treatment failure, and the agency determined the benefits “no longer outweigh the known and potential risks for its authorized use.” FDA had issued EUA for bamlanivimab to be administered alone to treat mild-to-moderate COVID-19 in November 2020 based on the scientific evidence that was available at the time.

“While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We urge the American public to seek out these therapies when needed while we continue to use the best data available to provide patients with safe and effective treatments during this pandemic.”

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

FDA Revokes Emergency Use Authorization for COVID-19 Treatment

CordenPharma announced on April 19, 2021 that it is expanding its lipid purification capacity at its Colorado site.

According to a CordenPharma press release, the expansion will include the addition of new production lines, which will be merged into the lipid manufacturing process in April 2021. By July 2021, the company expects a decrease in lipid shipment delivery time due to the expansion.

“CordenPharma is proud to contribute this major capital expansion to increase important lipid production for the global market,” said Michael Quirmbach, CEO and president, CordenPharma. “We have drawn upon longstanding expertise in specialized lipids to create an even stronger integrated network of facilities to support current and future projects.”

The company, who has also expanded its lipid supply chain at its facilities in Switzerland and France, manufactures four lipids used to formulate messenger RNA (mRNA)-based vaccines. They include:

Cationic lipids that condense negatively charged mRNA

PEGylated lipids that form a protective hydrophilic layer, which sterically stabilizes the lipid nanoparticle (LNP)

DiStearoylphosPhatidylCholine (DSPC), a phospholipid that offers a stable bilayer-forming structure

Plant-based cholesterol (CP BotaniChol), which stabilizes the LNP structures and enables endosome escape.

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

CordenPharma to Expand Lipid Purification Capacity at its Colorado Site

On April 16, 2021, Sartorius, opened a new state-of-the-art manufacturing facility for downstream bioprocessing equipment in Havant, Hampshire, United Kingdom. The company announced that the opening marks the official relocation of more than 90 employees to the new facility from Sartorius’ former Portsmouth site, located a few miles away.

The new 58,000-ft2 site will bring together skilled engineers with biochemical, electrical, and mechanical backgrounds who will design and manufacture a range of systems for the biopharmaceutical market, including chromatography columns and filtration systems that will save time and costs. These systems are crucial elements for the manufacture of injectable drugs needed to treat cancer and diabetes and for the production of vaccines to prevent the spread of viruses, Sartorius reported in a company press release. In addition to a 28,000- ft2 production area, the center accommodates a 4000- ft2 customer test lab to demonstrate the functionality of Sartorius equipment.

The company will invest more than €400 million in 2021 to expand manufacturing capacities around the world to meet the growing demand in the biopharmaceuticals market. In line with these investments, Sartorius aims to expand its Havant site and is now offering positions for process engineers, project managers, and design engineers as well as several support functions, among other job vacancies. With the new facility in Havant, the company now has five locations in the UK, employing more than 900 staff members.

“The new facility in Havant will be an important part of our global operations network as it will enable our business to grow to meet the requirements of the expanding industry,” said Thorsten Peuker, head of operations, BPS Systems, at Sartorius in the press release. “The new facility increases Sartorius’ capacity to deliver support in all areas of our business and provide the highest quality equipment and services to our customers.”

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

Sartorius Opens New Downstream Center of Excellence Facility in UK

 on conducting remote inspections, or, as the agency is calling them, “voluntary remote interactive evaluations (VRIEs)” at pharmaceutical and biologics facilities, using videoconferencing software, 360-degree video inspection, and other tools. The agency had been criticized for failing to take a stand on the use of remote inspection technologies in light of a growing backlog of plant inspections and delays in new drug approvals due to concerns about putting inspection staffers at risk of contracting COVID-19.

The guidance’s wording makes it clear that the agency views use of these technologies as a temporary measure, only for as long as US health authorities continue to define the COVID-19 pandemic as a public health emergency. However, it also suggests that FDA may use remote technologies in the post-COVID-19 world, as a way to supplement inspections, gain additional insights into issues found during a traditional inspection, or clarify questions or support a new drug application. The guidance also hints that technology may be used as a preliminary step, to better define the scope, depth, and timing required for future in-person inspections.

The guidance was issued without the customary public comment period, although FDA’s conservative approach and silence on the subject of remote technology had been discussed widely in the press and at industry events. Remote interactive evaluations would be used for pre- and post-approval inspections, surveillance inspections, follow-up and compliance visits, and bioresearch monitoring inspections.

FDA will use risk-management tools to determine when to ask a facility to participate, and may requests records or ask the company to take part in a VRIE before an on-site inspection.The agency also emphasized that it will not accept requests from facilities to perform inspections remotely, but will notify the facility if it wishes to set up a VRIE. FDA will contact the company and ask for information required to plan the evaluation ahead of time.

In order to prepare for the evaluation, FDA will schedule a brief meeting with the company to discuss staffing, key contacts and roles, logistics, expectations, and to outline key responsibilities. It will also ascertain any time zone differences and needs for interpreters.

Among the issues to be examined would be the facility’s capacity to host such evaluations, specifically the host facility’s internet access and its ability to live stream video and audio during an actual inspection. Discussions will come to an end if it is found that there is insufficient bandwidth or that remote video will not give adequate visibility into the operations or segments of the facility being evaluated.

FDA also says that it will not issue a Form 482 for these evaluations and that it will use its own government-issued Microsoft Teams, Zoom, and Adobe Connect platforms. It also asks that facilities be sure to make electronic documents accessible for sharing.

FDA also asks that facilities that are still using paper documentation ensure that it is scanned into PDFs when possible.

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

FDA Weighs in on Remote Inspections

Thermo Fisher Scientific announced on April 15, 2021 that it has acquired PPD, a clinical research services provider, for $17.4 billion.

The acquisition, which is expected to be completed by the end of 2021, will give Thermo Fisher access to PPD’s drug development platform, patient recruitment capabilities, and laboratory services, Thermo Fisher said in a company press release. The collaboration is expected to offer new solutions for customers, while reducing the time and cost of the drug development process.

"Pharma and biotech is our largest and fastest growing end market, and our customers value us as a strategic partner and an industry leader. The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers with important clinical research services and partner with them in new and exciting ways as they move a scientific idea to an approved medicine quickly, reliably, and cost effectively," said Marc N. Casper, chairman, president, and CEO, Thermo Fisher Scientific, in the press release. "Longer term, we plan to continue to invest in and connect the capabilities across the combined company to further help our customers accelerate innovation and drive productivity, while driving further value for our shareholders."

"This is a very exciting announcement for our shareholders and will provide customers with an even better opportunity to bring meaningful innovation to the market faster and more efficiently,” added David Simmons, chairman and CEO, PPD, in the press release. “Thermo Fisher is a world-class company with a very similar culture and values and will provide a great foundation for our colleagues to continue to deliver for our customers and to develop their own skills and careers."

The acquisition, which is expected to be completed by the end of 2021, will give Thermo Fisher access to PPD’s drug development platform, patient recruitment capabilities, and laboratory services.

Thermo Fisher to Acquire PPD for $17.4 Billion

Abzena, a US-based global partner research organization, announced on April 15, 2021 that it has chosen Sanford, NC, as the location for its new good manufacturing practices (GMP) facility.

The new facility, which will be designed specifically for phase III and commercial manufacturing of biologics, will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites, Abzena said in a company press release. The facility will also handle continuous manufacturing and perfusion, with manufacturing beginning in 2022.

“We are delighted to announce the investment of our newest site in Sanford, NC,” said Jonathan Goldman, MD, CEO of Abzena, in the press release. “Our goal is to support our partners and the patients they serve with this expansion in [C]GMP [current good manufacturing practice] biologics manufacturing services. We are pleased to provide integrated asset development with a full suite of in-house services from discovery through clinical and commercial phases without the need for technology transfer. We are very pleased to be welcomed by North Carolina.”

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

Abzena Names North Carolina Location for New GMP Manufacturing Facility

Catalent announced on April 15, 2021 that it has expanded its services at its clinical supply services facility in Philadelphia to include cryogenic capabilities for the support of cell and gene therapy development.

With the added cryogenic storage, cell therapies and other biological materials will be preserved in liquid nitrogen vapor at temperatures of around minus -180°C, Catalent said in a company press release. Additionally, the facility will have the ability to package, label, and distribute cryogenic materials.

“Establishing robust clinical supply chain services for cell and gene therapies is complex and challenging, and Catalent has undertaken an in-depth strategic review to evaluate how it can establish a safe, efficient, and flexible approach to support this fast-growing area of the industry,” said Ricci Whitlow, president, Catalent Clinical Supply Services, in the press release. “The solution we have implemented at Philadelphia not only meets current needs, but also provides a template for us to easily replicate at other facilities in our global network, allowing incremental capacity expansion within the new infrastructure as demand grows.”

Catalent plans to add cryogenic capabilities to its facility in Philadelphia, which will strengthen its ability to cryogenically preserve cell therapies and other biological materials.

Catalent to Add Cryogenic Capabilities to Support Cell and Gene Therapy Development

Hyalo Technologies, a US-based biopharmaceutical company has unveiled a new patented technology, called Sterilization with the Hyalo Matrix. This new method adds a matrix to enhance stability, allow for sterilization without degradation, and allow maintenance of drug efficacy at room temperature. The ability to remain stable at room temperature will ease up global distribution and reduce dependency on cold chain distribution of pharmaceuticals and biopharmaceuticals, including genetic materials, attenuated viruses, viral vectors, biologics, antibodies, biosimilars, protein subunits, nanosuspensions, and small and large molecules, the company reported in a March 29, 2021 press release.

Furthermore, when added to the drug molecule, the matrix can also effectively be sterilized, preventing degradation and preserving the integrity of temperature-sensitive materials.

The company's latest studies yielded positive results, which showed that the Hyalo Matrix is able to protect and enhance the stability of various biologics, antibodies, and biosimilars. After the matrix was added to each of these types of drug molecules and sterilized, the drugs were analyzed, with ≥ 95% of the drug molecules recovered. These results show the Hyalo Matrix helps preserve efficacy and enhance stability of each drug molecule.

Currently under the COVID-19 pandemic, vaccine manufacturers have been having issues with scaling up manufacturing as well as delayed distribution, bringing cold chain logistics into the spotlight. Hyalo Technologies reported in its press release that the current stats for cold chain logistics are as follows:

Roughly 80% of drugs require temperature-controlled transportation, and that trend is on the rise.

Cold chain requires close consideration of factors, including shipping modes, climate zones, storage capabilities, and healthcare settings.

Pharmaceutical manufacturers, distributors, logistics providers, and others risk the loss of temperature-sensitive products and, therefore, the loss of billions of dollars as evidenced by following:

30% of discarded pharmaceuticals can be attributed solely to cold chain logistics issues

25% of vaccines reach their destination degraded because of incorrect storage and transport during shipping

20% of temperature-sensitive products are damaged during transport because the cold chain has been broken at some point in the process.

"This new technology could eradicate the need for cold chain storage and transport as a drug can now be stable at room temperature, which will make global distribution quicker and more eficient," said Shalabh Jain, chairman and CEO of Hyalo Technologies, in the press release.

"This game-changing technology has the potential to enhance drug delivery and distribution," said Bob Oliver, executive advisor and board member of Hyalo Technologies, in the press release.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

On April 14, 2021, ATMPS, a UK-based provider of blockchain-based “vein-to-vein” cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, announced that they have formed a global non-exclusive collaboration to create an integrated digital data platform to support the development of advanced therapies.

Under the agreement, the partnership will integrate Ori’s proprietary CGT manufacturing platform’s data architecture with ATMPS’ Hataali, a secure data sharing platform that is specially designed to be a scalable system for advanced therapies. The combination of the two proprietary platforms is expected to provide improved product tracking, scheduling, and live monitoring of the manufacturing status across the entire CGT supply chain from vein-to-vein.

Hataali works by encrypting and storing data using distributed ledger technology through a process known as hashing. This process ensures data security is protected through a system of private keys and cryptography. The data platform was the first cell orchestration platform installed in a hospital globally, and ATMPS was the first blockchain company to integrate with the UK National Health Service for the delivery of advanced therapies, the company stated in a press release.

“Ori selected ATMPS’ Hataali technology for integration with our platform to allow the secure sharing of relevant process data with therapy developers, contract development and manufacturing organizations, and even clinicians or patients in real-time. This collaboration will provide increased visibility into the treatment process for those involved at each stage of the treatment process,” said Jason C. Foster, CEO, Ori Biotech, in the press release. “The addition of established technologies from companies like ATMPS allows Ori to further its mission of enabling partners across the CGT industry to bring therapies as safely, cost effectively, and quickly as possible to large numbers of patients with few alternative therapeutic options.”

“Ori is an ideal partner for ATMPS, as both companies share a common mission to lower the costs and improve processes for cell and gene therapies. Ori’s work in helping innovators scale from preclinical to commercial is a massive step towards reducing complexity and bringing these vital therapies to patients more quickly,” said Raja Sharif, CEO, ATMPS, in the press release. “We all know how challenging and expensive the development and manufacturing of CGTs can be. With the help of Hataali, Ori can securely leverage vein-to-vein data to advance their manufacturing solutions much more efficiently. This will enable real-time therapy tracking, improved patient trust, and expediated clinical development.”

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

ATMPS and Ori Biotech Collaborate on Integrated Digital Platform for Cell and Gene Therapy

 Washington Editor, jillwechsler7@gmail.com.

FDA Acting Commissioner Janet Woodcock announced this week that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since spring 2020. While not a surprise, the move makes clear that Woodcock will not return to that position at CDER, which she had held for much of the past 30 years (1).

Instead, Woodcock remains in limbo as the temporary head of FDA, a situation that has been lamented on all sides. Several months ago, she was expected to get the top job until that move drew opposition from certain consumer activists who regard her as too cozy with industry and responsible for permitting deadly long-acting opioids on the market. The situation has led to inaction at the White House, leaving the leadership of FDA as one of the few unfilled top administration positions, a notable concern in this time of public health emergency. Woodcock’s long experience and strong leadership at FDA makes her a prime choice to lead the agency after a year of indecision and errors under Stephen Hahn, who came to the job with little knowledge of FDA or federal government operations. With the COVID-19 pandemic still raging across the United States and the world despite effective vaccines and therapeutics, FDA continues to face difficult decisions as it strives to shepherd new therapies to patients.

In only three years at FDA, Cavazzoni has impressed colleagues and FDA stakeholders for being a capable administrator and creative problem-solver. Woodcock brought her to CDER in 2018 as deputy center director for operations, and she briefly served in 2019 as acting principal deputy commissioner. Before coming to FDA, she held executive positions involving pharmacovigilance and drug safety at Pfizer, Sanofi, and Eli Lilly. In the past year, Cavazzoni kept the drug regulatory process running smoothly, as the pandemic placed added pressures on drug development and approvals, particularly with the halt to field inspections needed to vet product quality.

A main challenge for Cavazzoni will be to explain and reassure Congressional leaders of the strength of various CDER programs and decisions, as the agency continues to face sharp scrutiny for its handling of drug testing and product approvals during the pandemic. CDER will be in the spotlight as it seeks approval of new drug user fee agreements and sufficient resources in the coming months. And with a number of long-term FDA officials poised to retire, Cavazzoni will face the challenging task of recruiting and retaining capable staff under difficult circumstances.

Woodcock was named FDA acting commissioner in January 2021 when the Biden administration took office. In closing her announcement about Cavazzoni, Woodcock acknowledged that, in addition to serving temporarily as the agency head, her official FDA position now is principal medical advisor to the commissioner, the role she assumed when detailed last May 2020 to head therapeutics development at Operation Warp Speed. Under current law, she can serve as acting commissioner only until mid-August, unless she or another person is named to the commissioner’s job. Woodcock could remain at FDA in her medical advisory role under a new commissioner, but it won’t surprise anyone if the chooses to retire from the agency at that time.

1. J. Woodcock, A Message From the Acting Commissioner, Personnel Update–CDER Director, April 12, 2021.

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

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