11.17.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads

Stay ahead in a competitive and fast-evolving market by optimizing packaging strategies that reduce risk, ensure compliance, and accelerate your path to market.

Here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.

Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

Bispecific antibodies (bsAbs) offer transformative therapeutic potential through dual-target engagement, but their complex structure presents significant manufacturing challenges.

If patients receive drugs that are compromised, the consequences could be fatal. Here, we examine how a new fill line was planned and implemented, while considering mitigating contamination risks.

Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

Venture capital in biotech remains strong, especially in C&G therapies. Uncover five key factors helping companies choose between in-house and outsourced process development strategies.

Unprecedented capital investments of >$8bn expand capacity to improve patient access. Going beyond expansions, learn more about a holistic, globally harmonized operational ecosystem.

JHS and groninger’s partnership powers expansion with advanced aseptic filling lines, driving innovation, quality, and community growth through shared values and strategic collaboration.

Asher Biotherapeutics was seeking a CDMO that could handle Phase 2 through to commercial production, as well as taking early-stage projects in its pipeline all the way through their lifecycle.

This experiment aimed to simulate initial bioburden filtration of the formulated product, in which the fluid is more likely to foul the filter, and so concentrates on filter throughput.

This site offers an integrated facility with a small-scale filling line, analytical capabilities, quality control labs, cold storage, and regulatory support, provided by our expert team of scientists and manufacturers.

Expedite success and be first to market with the Rapid Methods Package for your CHO bulk harvest testing. Find out how you can achieve 60% faster bulk harvest release testing.

Get access to our proprietary, IP-free, royalty-free E. coliexpression platform, the Keystone Expression System®, and to the mammalian platform using Gibco® Freedom® CHO-S® Kit from Life Technologies.

Consider potential problems during BLA submission, where a recent analysis of FDA complete response letters showed that 47% of the products received had CMC analytical issues.

With 92,000 square feet and a BSL-2 environment, Building G features single-use technology and is designed to meet top standards in pharmaceutical manufacturing in an expansive manufacturing space.