Due to globalization, restructuring of organizations, and the emergence of fast-paced technologies, companies need efficient and effective methods for validation, especially when establishing a defendable environmental sampling plan (the performance qualification [PQ] phase). This is especially true because there is a higher probability for regulatory agencies to scrutinize the documentation process during inspection when companies attempt to obtain licensure of their facility for the manufacturing of their products.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"
Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.
These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.
Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.
Due to globalization, restructuring of organizations, and the emergence of fast-paced technologies, companies need efficient and effective methods for validation, especially when establishing a defendable environmental sampling plan (the performance qualification [PQ] phase). This is especially true because there is a higher probability for regulatory agencies to scrutinize the documentation process during inspection when companies attempt to obtain licensure of their facility for the manufacturing of their products.
Pharmaceuticals, large and midsize, have a long history of rewarding reactive firefighting as opposed to proactively identifying problems and preventing issues from occurring. As a result, proactive risk management and the cultural change that goes with it have been a hard sell.
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
Learn what U.K. MHRA Senior GMDP Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity.
At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.
To make biofuels such as bioethanol and biodiesel competitive with fossil fuels extensive research in the field of process development is needed. Taking into account the special requirements of biofuel production, such as high temperatures, multi-step procedures and anaerobic conditions, effective tools for streamlining development efforts must be provided.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Commercial production of biologics requires development of a fermentation process that is time- and cost-efficient, and highly reliable. In an early stage of development, many process parameters are evaluated at small or bench scale to find the optimal conditions.
Fragment antigen binding domains, or F(ab) fragments, are derived from the upper branches of the ‘Y’-shaped antibody molecule. They form the antigen binding interfaces of intact antibodies.
Alvotech facility features a high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.
