Regulations Archives - Page 14 of 21 - BioProcess InternationalBioProcess International

Alexion on track with FcRn antibody after manufacturing hitch

After inheriting an impurity in the drug product of early-phase antibody ALXN1830, Alexion Pharmaceuticals says new batches will be available by the end of the year. In November 2018, Alexion Pharmaceuticals acquired Syntimmune in a deal worth up to $1.2 billion, adding ALXN1830, a clinical-stage humanized monoclonal antibody that inhibits the interaction of neonatal Fc receptor (FcRn) in trials for warm autoimmune hemolytic anemia (WAIHA) and generalized myasthenia gravis (gMG). But earlier this year, the firm discovered an issue in…

Single-use techs are garbage, eventually, and that’s great for biopharma

by Gareth Macdonald

Biopharma is starting to use single-use technologies more widely but understanding the pros and cons is vital say experts. The key characteristic of any single-use technology is its disposability. Being able to throw away rather than clean equipment after use is a major benefit. Cleaning a stainless steel system takes time and money says Andrew Sinclair, founder of Biopharm Services. “Cleaning a typical stainless steel system can be complex as the equipment and associated pipework needs to be cleaned together…

Biocon going digital to fix insulin plant hit with another FDA 483

by Dan Stanton

Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

Bluebird’s gene therapy latest to feel ‘inevitable’ teething problems

by Dan Stanton

Bluebird Bio’s $1.8 million gene therapy Zynteglo is the latest such therapy to suffer from manufacturing issues, causing a delay to its EU launch. The European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia in June. Developer Bluebird Bio has priced the therapy at €1.58 million ($1.8 million). However, a setback due to manufacturing problems means Bluebird is delaying launch to at least…

Henlius’ trastuzumab: EU to assess first China-made biosimilar

by BPI Staff

The European Medicines Agency (EMA) has accepted to review a version of Roche’s cancer drug Herceptin (trastuzumab) developed by Chinese biotech Henlius. The European agency has officially accepted to review the Marketing Authorization Application (MAA) of Shanghai, Henlius’ trastuzumab molecule HLX02, making it he first biosimilar developed and made in China to be up for review. Scott Liu, co-founder and CEO at Henlius, said the review “shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally…

Vaccines the ‘backwaters of the pharma industry’ due to low price expectation

by Dan Stanton

Historic low prices and the fact they are administered to healthy people means vaccine development plays second fiddle to biologics, according to a panel of experts. At the BPI West event in Santa Clara, California earlier this year, Rahul Singhyi, COO of Takeda vaccines, told delegates that vaccines used to be viewed as “the backwaters of the pharma industry.” Fast forward several months to the BPI Europe event in Vienna, Austria, and Bioprocess Insider asked four more experts within the…

Stem cell clinic crackdown continues with FDA letter to R3

by Dan Stanton

Despite receiving an untitled letter from the US FDA over its promotion of unapproved stem cell therapies, Arizona firm R3 Stem Cell, LLC continues to push its questionable therapies to “vulnerable patients.” The US Food and Drug Administration (FDA) has put Scottsdale, Arizona-based company R3 Stem Cell on notice for marketing unapproved stem cell treatments. In the untitled letter dated May 30, the Agency said R3, through its affiliated clinics, offers unapproved stem cell products for serious conditions including Lyme…

On the origin of serum: Controlling FBS supply, a riposte from the ESPA

by Dan Stanton

Do not confuse the methods and purposes for controlling the serum supply chain by misleading end-users into believing that some origins of serum are better and safer than others, says the European Serum Products Association (ESPA). Last month, Bioprocess Insider published an article entitled: ‘Quality FBS, or just BS? Industry turning to supply chain certification’. The article detailed a presentation from the International Serum Industry Association (ISIA) at BPI Europe in Vienna, Austria and highlighted the application of independent audits,…

Novartis wins approval for $2.1m gene therapy Zolgensma

by Dan Stanton

Novartis says it is ready to launch Zolgensma (onasemnogene abeparvovec) within the next few weeks after receiving FDA approval for its spinal muscular atrophy (SMA) single-dose gene therapy. Zolgensma, a single-dose, one-time gene therapy has been approved to treat children less than two years of age with spinal muscular atrophy (SMA). “Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” acting US Food and Drug Administration (FDA) commissioner…

FDA issues draft guidance on biosimilar analytical studies

by Dan Stanton

The draft guidance advises industry to minimize differences between a biosimilar and its reference biologic including in the choice of expression system and manufacturing process. The US Food and Drug Administration (FDA) has been active in encouraging biosimilar development of late, publishing its long-awaited interchangeability guidance earlier this month. In its latest push the Agency has issued draft guidance entitled: ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry.’ The document makes recommendations on…