The latest news, research, and development efforts from the bio/pharma community.

Pharma Takes on COVID-19

The pandemic raised questions about the safety of the pharmaceutical materials. Is onshoring the answer?

Safe, Secure, Steady Supply

Catalent announced on Sept. 24, 2020 that it has acquired a manufacturing facility in Bloomington, IN to create a new North American center of excellence for early-phase clinical biologics formulation development and drug product fill/finish services. The $14 million investment includes the acquisition, build-out, and qualification of the facility.

The 23,000 ft2 site, purchased from AB BioTechnologies and its affiliate, features a new Vanrx SA25 aseptic flexible filling line for the filling of lyophilized vials, syringes, and cartridges; formulation development capabilities; quality control laboratories; and controlled temperature storage, a company press release said. Set to be operational in January 2021, the facility will also be integrated with Catalent Biologics’ main Bloomington facility located nearby.

“The addition of this new small-scale filling capability underlines Catalent’s commitment to our customers with early stage programs looking to accelerate molecules into the clinic,” said Mike Riley, Catalent’s region president, Biologics, North America, in the press release. “The filling line will also be fully leveraged as part of our OneBio offering, an integrated solution for drug substance and drug product development, manufacturing, and clinical supply, enabling faster development timelines to Phase 1 clinical trials and beyond.”

Articles

The facility for early-phase clinical biologics formulation development and drug product fill/finish services will be integrated with an existing Catalent facility nearby.

Catalent Acquires New Biologics Facility in Indiana 

Evergreen Theragnostics, a radiopharmaceutical contract development and manufacturing organization (CDMO) formed in 2019, began construction of a manufacturing facility in Springfield, NJ, the company announced in a Sept. 23, 2020 press release.

The new 14,000-ft2 facility, which is expected to open in 2021, is designed to meet global current good manufacturing practice standards for radiopharmaceutical manufacturing, including therapeutic and centrally distributed diagnostic radiopharmaceuticals. The facility will have four fully equipped production suites, three additional customizable suites, research space, multiple sterility lines, quality control, material storage, and packaging space. 

The company plans to support preclinical and early-stage clinical trials and full-scale commercial manufacturing of approved products. The facility location was chosen for its proximity to transportation hubs and the pharmaceutical talent pool in the area.

"We are excited to take one more step forward in realizing our goal of providing high quality and high reliability manufacturing of radiopharmaceuticals in North America. We are encouraged to see companies in our industry developing so many exciting new drugs and are eager to provide a top-tier manufacturing service to support their efforts," said James Cook, CEO of Evergreen, in the press release.

The radiopharmaceutical CDMO is building a new cGMP facility in Springfield, NJ.

Evergreen Theragnostics Begins Construction of Manufacturing Facility

Hovione, a contract development and manufacturing organization, announced on Sept. 23, 2020 that it has signed a partnership agreement with Ligand, a biopharmaceutical company located in San Diego, CA, to increase the production output of Ligand’s Captisol, a chemically modified cyclodextrin used to improve the solubility and stability of drugs, for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

“To meet Captisol demand associated with Veklury, Hovione will soon be producing per month the quantity it usually produces in one year, said Jean-Luc Herbeaux, chief operating officer, Hovione, in a company press release. “This sudden spike in demand has required unique mobilization efforts across the Hovione network to secure additional raw material supply, execute major capital expenditure projects at our sites, maximize operational efficiency, hire additional talent, and identify external partners to expand our overall capacity. The pharmaceutical supply chain is working together in an unprecedented fashion to treat patients and save lives. Hovione is privileged to be part of this truly global response.”

“Ligand values its longstanding partnership with Hovione,” said Matt Foehr, president and chief operating officer of Ligand, in the press release. “Their excellent customer service, global commitment to quality, and high pharmaceutical standards make them an ideal partner for Captisol, a critical component for a number of life-saving medicines. We commend them for responsibly and efficiently partnering with Ligand to manage the scale up and expansion of their operations to contribute to global health during the pandemic.”

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

Hovione and Ligand Partner to Increase Production of Captisol for Use in Remdesivir

Piramal Pharma Solutions, a contract development and manufacturing organization (CDMO) headquartered in India, held a grand opening event at their recently acquired solid oral dosage drug product manufacturing facility located in Sellersville, PA. The company acquired the site in June 2020 from G&W Laboratories. This site gives Piramal capabilities for product and process development, manufacturing, and packaging of solid oral dosage forms, liquids, creams, and ointments in North America.

“We are rapidly growing and we take pride in the fact that we let our customers guide how and where we grow. The Sellersville facility is a great example of this. It was acquired because it addresses a market need for solid oral dosage form development and manufacturing in the United States. It also gives us new capabilities in liquids, creams, and ointments,” said Peter DeYoung, Piramal Pharma Solutions CEO, in the Sept. 21, 2020 press release.

“Bringing the Sellersville site into the family significantly helps us accomplish our goal of getting medicines to patients. This is the thirteenth facility in our global network and our first solid dose facility in North America, giving us critical mass that matches local market need,” said John Fowler, chief operating officer, Piramal Pharma Solutions, in the press release.

CMDO Piramal Pharma Solutions held a grand opening at a facility they acquired in Sellersville, PA.

Piramal Pharma Solutions Opens Oral Solid Dosage Drug Product Facility

Johnson & Johnson announced, in a September 23, 2020 press release, the launch of its large-scale, pivotal, multi-country Phase III trial (called Ensemble) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. Positive interim results from the Company’s Phase I/IIa clinical study demonstrated that the safety profile and immunogenicity after a single vaccination supported further development.

Johnson & Johnson has continued scaling up its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year, the company reported. The company anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.

The Ensemble trial will enroll up to 60,000 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. In order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites that have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated. Participants will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19. The company said in the press release that it “aims to achieve representation of populations that have been disproportionately impacted by the pandemic in the implementation of its COVID-19 Phase III trial program. In the US, this includes significant representation of Black, Hispanic/Latinx, American Indian, and Alaskan Native participants.”

In addition to this trial of a single-dose regimen, the company announced in an Aug. 14, 2020 press release that it agreed in principle to collaborate with the UK government on a separate Phase III clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, chairman and CEO, Johnson & Johnson, in the press release. “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

The vaccine candidate uses the Company’s AdVac technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. The technology platform has been used to vaccinate more than 100,000 people to date across Janssen’s investigational vaccine programs. A vaccine made with the technology is estimated to remain stable for two years at -20 °C and at least three months at 2–8° C, which makes a vaccine candidate compatible with standard vaccine distribution channels.

The company said it continues discussions with national governments and global organizations, as part of its efforts to meet its commitment to make the vaccine candidate accessible globally, provided the vaccine is demonstrated to be safe and effective and following regulatory approval.

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents. 

Johnson & Johnson Launches Multi-Country Phase III Trial of Janssen’s COVID-19 Vaccine Candidate

Humanigen, a clinical stage biopharmaceutical company, and Thermo Fisher Scientific announced on Sept. 23, 2020 that they are entering into a strategic collaboration to expand manufacturing capacity for Humanigen’s COVID-19 therapeutic candidate, lenzilumab.

Under the terms of the agreement, Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020, a Humanigen press release said.

“Manufacturing preparation, precision, and expertise are critical as we execute on an aggressive strategy, pending a potential EUA [emergency use authorization] from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier,” said Cameron Durrant, MD, CEO of Humanigen, in the press release. “Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory."

“Effective therapeutics are an important part of the overall approach to curb the arc of the current pandemic and we are committed to enabling leading therapeutic innovations forward for patients through comprehensive supply chain capabilities and expertise,” added Leon Wyszkowski, president, commercial operations for Thermo Fisher’s pharma services business, in the press release.

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

Thermo Fisher and Humanigen Partner for COVID-19 Therapeutic Candidate

Aphena Pharma Solutions, a biologics contract manufacturing and packaging company, announced on Sept. 23, 2020 that it has acquired a 500,000 ft2-site in Cookeville, TN, to expand its solid dose division.

The $21-million expansion will provide the company with space to install 24 high-speed bottling lines and eight thermoform blister packaging lines, along with 200,000 ft2of warehouse space for a third-party logistics program, a company press release said. The renovations are expected to be completed by Feb. 1, 2021 and, upon completion, Aphena will move its corporate headquarters to the new location.

“This new facility will make Aphena a top contender in the pharmaceutical contract service space, starting with over 12,000 pallets of cold chain storage capacity,” said Eric Allen, Aphena’s executive vice-president of sales, in the press release. “Being able to offer turnkey packaging and distribution services for biologic products, plus expanding the current operations with newly innovated bottling and packaging lines, will continue to attract key pharmaceutical customers to the middle Tennessee area.”

“This expansion is exciting news for Aphena, our customers and our communities,” added Aphena CEO Shawn Reilley, in the press release. “The solid dose division and recent liquids division expansions will establish Aphena’s position as one of the most diversified manufacturing and packaging companies in the pharmaceutical industry. These growth strategies will continue to offer our customers expanded project capabilities at every level, and it will create a very large employment opportunity, both in Cookeville and at our facility in Easton, Maryland.”

The renovations are expected to be completed by Feb. 1, 2021 and, upon completion, Aphena will move its corporate headquarters to the new location. 

Aphena Pharma Solutions Announces $21-Million Facility Expansion in Tennessee 

Biotechnology company, Moderna, and international research-focused healthcare group, Chiesi Farmaceutici (Chiesi Group), have announced a collaboration aimed at the discovery and development of messenger RNA (mRNA) therapeutics to treat pulmonary arterial hypertension (PAH).

The collaboration, which was announced in a Sept. 16, 2020 press release, will see Moderna leverage its mRNA technology and delivery platforms, alongside Chiesi’s expertise, to lead discovery efforts in PAH biology. Chiesi Group will lead the development and commercialization activities and will have the responsibility of funding the collaborative expenses.

“We are excited to begin this collaboration with Chiesi Group, which provides the opportunity to further leverage our mRNA and delivery technology,” said Stephen Hoge, president of Moderna, in the press release. “This new relationship continues our commitment to partner with companies that have unique expertise in serious diseases, and who share our vision of using mRNA therapeutics to address the unmet needs of patients.”

“Chiesi Group is at the forefront of innovation and discovery of novel therapies for people affected by diseases with high unmet medical need,” added Ugo Di Francesco, CEO of Chiesi Group, in the press release. “And the agreement with Moderna, a leader in mRNA science and delivery, confirms our commitment to better serve patients and healthcare professionals with transformative solutions.”

Under the terms of the collaboration, Moderna will receive a $25 million payment upfront and is eligible for more than $400 million in development, regulatory, and commercial milestones, in addition to tiered double-digit royalties on net sales.

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics

The Korean Ministry of Food and Drug Safety (MFDS) has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59, following positive interim results from the Phase I trial.

According to a Sept. 17, 2020 press release, Celtrion had submitted an investigational new drug (IND) application for the clinical trial in six countries and has plans to enroll more than 1000 patients from up to 12 countries. The Phase II/III trial will assess the safety and efficacy to CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection.

“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilize our response to the pandemic. The initiation of the global Phase II/III pivotal trial of CT-P59 is an important step forward, and together with the ongoing Phase I trial in patients with mild symptoms, Celltrion remains committed to investigating a potential anti-COVID-19 monoclonal antibody treatment,” said Dr. Sang Joon Lee, senior executive vice-president of Celltrion, in the press release.

The company has already begun manufacturing the process validation batch of its anti-COVID-19 treatment and has plans to increase manufacturing capacity to meet global and domestic demand.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment

The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners. The guide’s availability was announced in a Sept. 17, 2020 press release.

“This guide provides the requirements, principles, and practices for cleaning validation in a single volume and is the first of its kind in the industry,” said Jose Caraballo, head Audit Program Management Americas, Corporate Quality Audit and Inspections, Bayer US, Guide co-lead, in the press release. “We decided to address the topic because the expectations for cleaning validation are changing. This guide was written by a group of experts and reviewed by regulators and practitioners in the field. It is a great resource for understanding and applying the principles for compliant cleaning programs, including how-to steps and examples.”

Cleaning Validation Lifecycle—Applications, Methods, and Controls

 covers key areas, such as cleaning methodologies, determination of visual inspection limits, validation of testing and sampling methods, creation of cleaning validation acceptance criteria, and change management. The explanatory and hands-on guidance is available to be purchased online, along with ISPE’s other resources.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.