Pharmaceutical Technology Editors

Lonza and aTyr Pharma, a US-based biotherapeutics company, announced on April 14, 2021 that they have entered into an agreement for the manufacture of ATYR2810, aTyr’s monoclonal antibody (mAb) that targets the neuropilin-2 (NRP2) protein. The mAb is currently in preclinical development for the treatment of cancer.

Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture current good manufacturing practice (CGMP) material for the mAb while supporting the process from gene to investigational new drug (IND) filing, Lonza said in a company press release. Additionally, Lonza will offer drug substance and drug product for toxicological studies in animals and early clinical development in humans; full process support, including cell line development, process development, and supply chain simplification; and drug substance and drug product manufacturing at its sites in Visp and Stein, Switzerland.

“We look forward to supporting aTyr as they advance their novel therapeutic antibody from preclinical stages into the clinic. This collaboration signifies our commitment and flexibility in accommodating the specific and unique needs of small biotech companies,” said Jennifer Cannon, senior vice-president, global head of Mammalian Biologics, Lonza, in the press release.

“As we prepare to advance ATYR2810 to clinical stage development, we are pleased to work with Lonza, a partner with extensive and proven capability in antibody manufacturing, for the production of our first anti-NRP2 antibody,” added Sanjay S. Shukla, president and CEO, aTyr, in the press release. “Having recently initiated IND-enabling activities for ATYR2810 following some compelling preclinical data in triple-negative breast cancer, strengthened by additional data in lung cancer, this agreement with Lonza reflects our commitment to this program and will support our efforts to advance ATYR2810 to in-patient trials in cancer, including certain aggressive tumors where NRP2 is implicated.”

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Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture cGMP material for the mAb while supporting the process from gene to IND.

Lonza Partners with aTyr Pharma for mAb Manufacturing

Patrizia Cavazzoni was named director of FDA’s Center for Drug Evaluation and Research (CDER) on April 12, 2021, having served in an acting director role for more than one year.

Cavazzoni was appointed acting director in 2020 when then CDER Director Janet Woodcock left FDA to oversee therapeutics development for Operation Warp Speed, the federal government efforts to combat COVID-19. Woodcock, current acting commissioner for FDA, made the announcement via 

Cavazzoni joined FDA in January 2018 as CDER’s Deputy Director for Operations; she was acting principal deputy commissioner of food and drugs from January–February 2019.

Cavazzoni earned a medical degree at McGill University in Canada. She was an investigator in clinical trials of novel antipsychotic and antidepressant medications, was appointed to the faculty of medicine at the University of Ottawa, and joined the Mood Disorders Program at the Royal Ottawa Hospital. Later, Cavazzoni worked in the pharmaceutical industry and held senior positions in clinical development, regulatory affairs, and safety risk management across multiple therapeutic areas, until she joined FDA in 2018.

Cavazzoni is certified by the American Board of Neurology and Psychiatry and is a fellow of the Canadian Royal College of Physician and Surgeons and the Canadian College of Neuropsychopharmacology.

“Having spent most of my career with CDER, I have a deep appreciation of the role. Dr. Cavazzoni’s credentials are of the highest caliber, and I know she will continue to excel in advancing the FDA’s public health mission for the benefit of all,” Woodcock noted on Twitter.

, Cavazzoni thanked Health and Human Services Secretary Xavier Becerra and Woodcock “for entrusting me with leading CDER, and I look forward with gratitude and anticipation to serving the center and the public for many years to come.”

Acting FDA commissioner announces permanent appointment of Patrizia Cavazzoni as CDER director, following year-long acting-director role.

Cavazzoni Named CDER Director

Catalent announced on April 13, 2021 that it has completed its expansion of two new mammalian cell culture suites at its biologics drug substance development and manufacturing facility in Madison, Wis.

Each suite feature a 2x2000-L single-use bioreactor system aimed at processing batches of 2000 liters or 4000 L for current good manufacturing practice (CGMP) clinical and commercial manufacturing, Catalent said in a company press release. The first engineering batch in one new suite started in March 2021, with the first CGMP batch expected to be manufactured during May 2021. The second suite is set to begin its first engineering batch in May 2021 and its first CGMP batch in July 2021. The new manufacturing suites add to an existing 2×2,000-L suite, a 1000-L suite, and a 500-L suite.

“This new capacity will allow us to meet growing clinical and commercial demand from both existing and new customers,” said Mike Riley, region president, Biologics, North America, Catalent, in the press release. “Catalent’s continued investment in technology and capacity will enable us to bring our customers’ important and innovative treatments to patients faster.”

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

Catalent Completes Expansion of its Biologics Drug Substance Facility in Wisconsin  

Woodstock Sterile Solutions, a blow-fill-seal (BFS) contract development and manufacturing organization, announced on April 12, 2021 that it has named Bill Hartzel as its first Chief Commercial Officer.

Hartzel, who will now be responsible for the commercial activities and strategy for the company, previously served as product manager in Medication Delivery Solutions; director of Strategic Execution; regional director of Commercial Operations; and global vice-president of Business Development for Analytical, Respiratory, and Ophthalmics for Catalent, Woodstock’s predecessor, the company said in a press release.

“We are pleased to welcome a dynamic, customer-focused leader like Bill Hartzel to the Woodstock executive team,” said Paul Josephs, CEO, Woodstock, in the press release. “Bill has had an impressive career in the BFS industry and we look forward to him bringing the exceptional business and technical acumen he has demonstrated throughout his career to our leadership team to help us drive sustainable growth for the organization.”

“I am very excited about the opportunities and the potential for growth for Woodstock Sterile Solutions in the pharmaceutical and healthcare industry,” added Hartzel in the press releease. “BFS is an untapped technology and it is primed for growth and expansion—not just in the respiratory and ophthalmic space—but as a sterile delivery platform, where it can help to mitigate the risks involved with sterile manufacturing. The Woodstock business is uniquely positioned to support complex formulations seamlessly from development through commercial production. I look forward to helping Woodstock Sterile Solutions reach its full potential in this market.”

Bill Hartzel has been named as Woodstock’s first Chief Commercial Officer. 

Woodstock Sterile Solutions Appoints First Chief Commercial Officer

FDA and the Centers for Disease Control (CDC) 

 on April 13, 2021 that they are evaluating six cases in the United States of a rare and severe type of blood clot, cerebral venous sinus thrombosis (CVST), that occurred in women after they received the Johnson & Johnson (J&J) vaccine. The CVST clot was seen in combination with low levels of blood platelets and occurred in women ages 18–48. The symptoms appeared 6–13 days after vaccination.

CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Wednesday, April 14, 2021 to review the cases. FDA will then review the CDC analysis as a part of its investigation into the matter. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” FDA stated in a press release.

FDA’s decision to pause the use of the J&J vaccine is cautionary, stating the rarity of the adverse events. The agency recommends, however, that anyone who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of the J&J COVID-19 vaccination contact their health care provider.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

Airway Therapeutics, a US-based biopharmaceutical company, announced on April 12, 2021 that FDA has accepted its investigational new drug (IND) application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

Following the IND acceptance, the company will begin a Phase Ib clinical trial to determine the feasibility of intratracheal administrations of AT-100 and its safety and tolerability profile, Airway said in a company press release. In previous preclinical studies, the protein reduced inflammation and infection while regulating immune response for multiple respiratory diseases inside and outside the lung. Studies have also shown AT-100 has the potential to prevent SARS-CoV-2 duplication and promote viral elimination while reducing secondary infections in COVID-19 patients who are ventilated in intensive care.

“The pre-clinical data are encouraging and lead us to believe that AT-100 has therapeutic potential against COVID-19 by reducing infection and inflammation in mechanically ventilated seriously-ill patients who require a range of treatment options,” said Marc Salzberg, MD, CEO of Airway, in the press release. “We are excited to advance the clinical development of AT-100 with the goal of delivering a novel therapy for severely ill COVID-19 patients who are in need of new treatment options.”

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.