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Redefining Cell Line Development with a New Automated Clone Screening System
BioProcess Insider Daily - Biotech Week Boston
Read MoreAndrew Mears, CEO of Lead Candidate, highlighted a dichotomy in the industry, where some sectors are downsizing while others are experiencing rapid growth during a video interview at Biotech Week Boston (BWB).

Experts call for better analytics, customization, R&D, and strategic investments as cell and gene therapies struggle with funding challenges and complex manufacturing needs.

Aurigene’s chief commercial officer says his firm and other Indian CDMOs are “a very viable alternative” if major Chinese manufacturers are removed from the US biopharma supply chain.
Cell therapies will play an increasingly important position in AstraZeneca’s broad oncology pipeline, an SVP told delegates at Biotech Week Boston (BWB) last month.
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This case study highlights how Avid Bioservices, a contract development and manufacturing organization (CDMO), collaborated with an emerging biotechnology company to address complex biomanufacturing challenges within an ambitious 12-month timeline. The client aimed to transition a difficult-to-express bispecific fusion protein from human embryonic kidney (HEK) cells to Chinese hamster ovary (CHO) cells, a shift critical for industrial scalability and regulatory approval. Avid’s proficiency in cell line development (CLD) resulted in a CHO-cell clone achieving more than a 10-fold improvement in productivity. To accommodate the tight timeline, Avid began process development earlier than usual, leveraging stable pools to accelerate purification and analytical evaluations. The bispecific molecule’s sensitivity to pH required innovative purification strategies, incorporating mixed-mode chromatography and high-throughput techniques to ensure product stability and quality. Through expertise and a collaborative ap...
The biopharmaceutical industry is undergoing significant digital transformation. Traditional tools like spreadsheets can no longer keep pace with increasing complexity and stricter regulatory requirements. Digital platforms are reshaping how companies manage data, automate processes, and maintain compliance. When integrated with Quality by Design principles, these technologies evolve from conceptual strategies to practical solutions, driving better outcomes from the outset. This report highlights real-world examples of organizations using ValGenesis iRisk to replace manual workflows, explores the challenges of digital transformation, and provides insights into its future in pharmaceutical development. To learn how digital tools can help align your operations with regulatory standards and improve efficiency, download the report and explore the possibilities. Register or Login and hit Download Now to get the full Special Report.
Ask the Expert Webcasts
This webcast features: Sushmita Koley, PhD, Staff Scientist, Process Chromatography R&D, Bio-Rad Laboratories. Chromatographic purification process is a critical step in the biomanufacturing of molecules such as monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), and other recombinant proteins. After the initial capture step, polishing chromatography typically involves two to four orthogonal steps using anion exchange, cation exchange, or hydrophobic interaction chromatography. Although these traditionally operated single-mode ion-exchange chromatography methods have been employed in the downstream processing of biotherapeutics, achieving high purity and yield has often been challenging. To overcome these limitations, there has been a significant increase in the implementation of multimodal adsorbents for purification processes which not only help to reduce the number of steps, but also improves the overall process economics and achieve the sustainability goals. In this webcast, learn how Bio-...
This webcast features: Shanshan Wang, PhD, associate director, Innoforce Pharmaceuticals. The therapeutic potential of mRNA-based therapies is rapidly being recognized across various fields, positioning the mRNA sector as a fast-emerging area of innovation. Beyond conventional mRNA, circular RNA (circRNA) and self-amplifying RNA (saRNA) are gaining significant attention as promising molecules for RNA-based vaccines and therapeutics. However, the development of circRNA and saRNA faces numerous CMC challenges, including impurity removal in circRNA production (e.g., precursor RNA and nicked RNA), process scalability, integrity analysis for both circRNA and saRNA, and effective encapsulation strategies. Innoforce’s RNA Center of Excellence is dedicated to achieving scalable, high-quality production of RNA molecules, including mRNA, circRNA, and saRNA, through advanced process development and optimization. Leveraging extensive platform development and project execution experience, they have successfully add...