12.02.24 -- Go Ahead, Outsource Your Entire Biotech

The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving speculation over the implications for biotech and other life sciences industries. How should biotech builders be obviating? On the Business of Biotech, we're joined for some reflection by none other than Allan Shaw.

Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Consider why pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development.

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

Partnering with a CDMO can offer numerous benefits, however, several challenges must also be navigated. Review key considerations for overcoming these challenges and enhancing collaboration.

Understand why DFM discussion must be concise and backed by both historical data and up-to-the-minute insights, e.g., discovered through prototyping, test runs, etc.

When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS, here.

Uncover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

As demand for biologics rises, small biotechs and academic researchers face challenges finding CDMOs that specialize in small-scale mammalian cell culture for preclinical and early clinical trials.

In 2024, see why biotech contract manufacturers are doubling down on growth, expanding capabilities in combination product and drug-fill/finish manufacturing to meet the evolving needs of the industry.

Join Boehringer Ingelheim in driving innovation, sustainability, and healthcare advancements in China, creating a healthier future for humans and animals alike.

Here, we address attendee questions from a recent webinar about a new biomanufacturing site in Waltham, MA, equipped with state-of-the-art equipment.

Working with the right CDMO is vital for successful drug lifecycle management. We serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access.

Leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.

Gain flexibility to serve design space requirements for continuous, episodic, or delayed subcutaneous delivery of volumes up to 3 mL for up to three-day wear.

See how Resilience prioritizes agile supply chains to ensure health security and swiftly respond to emerging needs, positioning itself as a leader in biomanufacturing excellence.