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US FDA suspends all domestic GMP surveillance inspections

Agency responds to COVID-19 pandemic’s US arrival by suspending domestic surveillance inspections and non-critical for-cause and preapproval inspections. The US Food and Drug Administration (FDA) announced a suspension of all domestic good manufacturing practice surveillance and non-critical for-cause and preapproval inspections for the duration of the COVID-19 public health crisis as part of decision to require all eligible employees to telework. The aim is to wind down all inspections by 3 April. Exceptions will be made for inspections of facilities…

Rapid response vaccine capacity vital for pandemics, BIO-Europe

by Gareth Macdonald

Experts fighting COVID-19 say governments and industry must invest in vaccine plants that can be brought online during future pandemics. The call came during the online conference BIO-Europe Spring plenary session. Moderna CEO Stéphane Bancel – whose RNA vaccine entered Phase I trials weeks after the SAR-COv2 sequence was published – told delegates rapid scale-up is vital during a pandemic. “The piece we are missing is infrastructure – Moderna is using a development plant to make vaccine for trials and…

Compounders complain they can’t make these four drugs once they’re deemed biologics

by Joanne Eglovitch

After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say. Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s (FDA’s) decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say. The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be…

Individualized gene therapy: FDA considering device-like manufacturing approval process

by Derrick Gingery

CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

by Dan Stanton

Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others. In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze. The technology consists of…

Manufacturing quality systems first defense against hackers says expert

by Gareth Macdonald

An effective quality management system is a must for biopharmaceutical firms looking to protect their data assets against hackers according to a leading cybersecurity expert. Increasingly biopharmaceutical manufacturing relies on data. Ensuring optimal conditions are maintained in bioreactors or that chromatography systems are functioning properly depends on monitoring systems that feed information back to control systems. Likewise, data is key to how biopharmaceutical products are tracked through packaging and distribution systems to ensure they get to the correct hospital, pharmacy…

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

by Dan Stanton

Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…

Akron says biopharma needs GMP framework for ancillary materials

by Gareth Macdonald

Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety. Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs. Instead there are several independent GMP frameworks for such materials. These include…

Potential Oklahoma anti-vax bill danger to health and industry

by Dan Stanton

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

US FDA predicts gene therapy surge and moves to clarify expectations

by Gareth Macdonald

Gene therapy developers targeting the US market have a clearer idea of what it will take to win approval thanks to new guidance documents issued by the FDA. The US regulator set out its expectations for developers in six documents published last week. There are final guidance documents on gene therapies for hemophilia, retinal disorders and rare diseases. In addition, there are final guidance documents on chemistry, manufacturing and controls (CMC), observational studies and on the assessment of gene therapies…