Outsourced Pharma

JUNE'S FEATURED EDITORIAL BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience. A CMC Playbook For Leadership And Hiring Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know.

Balancing in vivo potency and safety Achieve targeted, durable CAR expression while limiting off-target toxicity and immune reactions Complex formulation and conjugation Combine genetic payloads with delivery systems deliver precise control Expanded analytical requirements Advanced bioanalytical methods are used to characterize both vector and formulation attributes Cross-modality GMP scale-up End-to-end solutions manage viral vector or RNA-LNP production, formulation, and fill/finish New...

Q&A With Evan Rafanello Gain practical perspective on emerging capabilities, common sponsor challenges, and what will matter most as the CDMO landscape continues to evolve. Compressing Analytical Timelines Without Cutting Corners Efficient analytical development speeds decisions and improves risk visibility. Using QbD, digital tools, and strong communication helps teams accelerate timelines while maintaining rigor.

If you're developing an antibody-drug conjugate (ADC) or antibody-oligonucleotide conjugate (AOC), the science may be the easiest part. The harder work is building a development program that actually holds up under clinical and regulatory scrutiny. Regulatory and bioconjugation specialists Jeffrey Mocny and Nicolas Camper lay out where programs most often run into trouble, and it's almost always earlier than developers expect.

As sterile manufacturing demands evolve, facility design is under increasing pressure to deliver speed, flexibility, and consistent quality. Rising complexity — from biologics and GLP-1 therapies to varied batch sizes and accelerated tech transfers — has exposed the limitations of legacy fill-finish operations. Modern approaches emphasize purpose-built environments that integrate contamination control, independent manufacturing suites, and optimized material and personnel flows from the outset.

Guest Column | July 10, 2026 By Ian Glassford, VP of Bioconjugation Development & Technical Excellence Antibody-oligonucleotide conjugates (AOCs) combine the targeting precision of antibodies with the gene-modulating power of oligonucleotides, short nucleic acids that can silence, splice, or redirect gene expression.

Guest Column | July 10, 2026 By BioPhorum Cell therapies (CTs) face unique challenges in visible particulate control and detection compared to other injectables. These include difficult-to-inspect formulations and containers, inherent cell-related particulates that limit the detection of other particles, and terminal sterilizing filtration that is not applicable due to cell size and formulation needs.

Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. today announced that the companies have entered into a license and commercialization agreement for OPUVIZ (aflibercept), a biosimilar referencing EYLEA1 (aflibercept), in Canada. Under the agreement, Samsung Bioepis is responsible for registration and manufacture of the products, while Teva Canada (a subsidiary of Teva Pharmaceutical Industries Ltd.) is responsible for commercialization.

Tel Aviv, Israel & Zug, Switzerland (BUSINESS WIRE) - Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: and TASE: TEVA) and Polpharma Biologics International AG today announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus®1 (ocrelizumab), upon regulatory approval.

London /PRNewswire/ - Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company") today announced that its wholly owned subsidiary, Virax Biolabs (UK) Limited, has entered into an exclusive multi-country commercial supply agreement with Fosun Diagnostics for the Company's ImmuneSelect research-use immune profiling product line.