Regulations

Gilead’s Kite receives US FDA ok for Maryland CAR-T plant

The 20-acre site in Frederick, Maryland will produce CAR-T therapy Yescarta and increase its network capacity by 50%, says Kite. In 2018, Gilead Sciences, fresh from its¬†$11.9 billion acquisition¬†of Kite Pharma, announced plans to expand its manufacturing network with a 275,000 square foot facility in Frederick County, Marland to produce chimeric antigen receptor (CAR) T-cell therapies. Now, the firm has received approval from the US Food and Drug Administration (FDA) to manufacture CAR-T cell therapy Yescarta (axicabtagene ciloleucel), which was…

Gene therapy sector needs tech to meet regulatory requirements

Manufacturing rules are a major challenge for gene therapy firms according to researchers, who say industry needs better tech to meet regulatory requirements. The call for better technology came in a new study published in the journal Molecular Therapy earlier this month, in which progress seen in the cell therapy space was compared with the slower growth of the commercial gene therapy market. ‚ÄúCell-based therapies have revolutionized the treatment of some blood cancers‚Ķ Gene therapy, on the other hand, has…

China: US auditors can examine US-listed companies in policy change

China plans to furnish US auditors with full access to the financial records of China companies that have US listings. The change seems to solve a looming crisis between the two countries, as the US is currently threatening to de-list all China companies that closed their financial documents to US auditors. The revised regulation will allow scrutiny of China-based companies‚Äô books, while detailing how to handle national security information, which will remain protected. The new policy was announced earlier this…

Moderna recalls another lot of COVID-19 vax

Moderna has recalled one lot of its COVID-19 vaccine, Spikevax, after a foreign body was found in a vial produced by CDMO Rovi. ¬† Moderna and Spanish contract development manufacturing organization (CDMO) Laboratorios Farmac√©uticos Rovi jointly announced that they have recalled lot #000190A of Spikevax in Europe, which consisted of 764,900 doses. The firms were made aware of the issue through a product complaint from a vaccination center based in Malaga, Spain. The dose in question was returned for forensic…

Trade secrets theft: ‚ÄėUnfair to the innovator, unfair to the industry‚Äô

Two co-founders of Taiwanese firm JHL Biotech were sentenced last month for plotting to steal trade secrets from Genentech and commit wire fraud exceeding $101 million. BioProcess Insider spoke to the attorneys who represented Genentech in this landmark civil and criminal case. According to¬†the suit, the story goes back thirteen years where former principal scientist Xanthe Lam and her husband, Allen Lam, conspired to commit stealing trade secrets from Genentech and passing the information to Taiwanese company JHL Biotech (now¬†Eden…

Alnylam RNAi candidate delayed due to packaging CDMO issues

Alnylam says an inspection at a secondary packaging facility run by a third-party has pushed the FDA‚Äôs approval date for vutrisiran back three months. Alnylam Pharmaceuticals is a pioneer in the RNAi space, becoming the first company to bring a small interfering ribonucleic acid (siRNA) treatment to the market with Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) in¬†August 2018. Since then, the firm has achieved success with Givlaari (givosiran) and Oxlumo (lumasiran) but has suffered a…

Novartis’s $115m pays off as FDA approves second Zolgensma site

The Novartis facility in North Carolina will begin shipping Zolgensma gene therapy doses immediately after receiving US FDA commercial licensure approval. The Swiss Big Pharma firm announced yesterday the US Food and Drug Administration (FDA) has granted approval to its multi-product gene therapy manufacturing facility in Durham, North Carolina. The 170,000 square-foot facility site will primarily be used to produce Zolgensma (onasemnogene abeparvovec. Novartis added Zolgensma to its pipeline through the $8.7 billion acquisition of AveXis in May 2018 and…

Rolontis review: Spectrum confident manufacturing deficiencies resolved

Spectrum Pharmaceuticals has resubmitted the BLA for eflapegrastim following the remediation of manufacturing deficiencies at a drug substance facility in Korea. In August 2021, Spectrum received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its long-acting granulocyte-colony stimulating factor (G-CSF) agent Rolontis (eflapegrastim). The letter, which put a hold on Spectrum‚Äôs Biologics License Application (BLA) for eflapegrastim, identified manufacturing challenges. But during his firm‚Äôs fourth quarter 2021 financial call last week, CEO Tom Riga…

15 year follow-up for gene editing outlined in FDA draft guide

The US FDA has set a 15 year follow-up period for therapeutic gene editing and edited products in new draft guidelines. The guidance ‚Äď available here ‚Äď covers therapeutic use of gene editing techniques like ZFN, and CRISPR, as well as gene therapy products made using those techniques. The aim, according to the FDA, is ‚Äúto assist in the translation of these products from the bench to clinical trials, this guidance includes recommendations for how to assess the safety and…

J&J taking ‚Äėdisciplined‚Äô approach to CAR-T rollout

‚ÄúCAR-T cell manufacturing is not a finished product,‚ÄĚ says J&J EVP Mathai Mammen as he speaks about his firm‚Äôs rollout of recently approved myeloma therapy Carvykti. Last month, Johnson & Johnson received the regulatory thumbs up for its chimeric antigen receptor T-cell (CAR-T) therapy Carvykti (¬†ciltacabtagene autoleucel; ciltacel), developed with China-focused partner Legend Biotech. The therapy is the second BCMA CAR-T approval ‚Äď Bristol-Myer Squibb‚Äôs Abecma (ide-cel) received FDA approval in March 2021 ‚Äď and the first cell therapy success…