Feliza Mirasol is the science editor for BioPharm International.
Exploring the Impact of Fixed-Bed Bioreactors in Upstream Processing
The innovation of going from stainless-steel bioreactors to fixed-bed bioreactors shows an evolution in upstream optimization.
SMB Technology Supports Shift to Continuous Biomanufacturing
SMB technology in the downstream can facilitate the shift to continuous bioprocessing.
Takeda Gets Approval in Japan for Entyvio Subcutaneous Injection
Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.
Exothera Partners with Remedium to Scale-Up Manufacturing of Gene Therapy Drug Candidate
CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.
Takeda to Invest ¥100 Billion (US$754 Million) into New Plasma Therapy Manufacturing Facility
Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.
Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases
Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.
Sanofi Drops Lantus US List Price by 78%, Capping Out-of-Pocket Costs at $35
Sanofi intends to cut its US list price for Lantus (insulin glargine injection) by 78% and cap out-of-pocket costs at $35 for all patients with commercial insurance.
BioNTech and OncoC4 to Co-Develop mAb for Solid Tumor Indications
BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.
Sartorius and Teknova Team Up for Gene Therapy Process Development
Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.
Samsung Biologics to Build Plant 5 as Part of Capacity Expansion to Bio Campus II
Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.
Sandoz to Build New Biologics Production Facility in Slovenia
Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.
Catalent Licenses Bhami Research Laboratory Technology for Biologics Formulation Development
Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.
Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies
The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.
Robust Development Fuels Drive to Finish Line
A slew of late-stage clinical trials is expected to push new regenerative medicines onto the market in the next few years.
Optimizing Vectors to Standardize Success
Improvement in viral vector yield has become integral to new cell and gene therapy product development.
Benefits of Technologies Facilitate Adoption of Single-use Systems
Single-use systems hold key benefits for biomanufacturers, despite certain limitations.
Complex Analytical Workflows Increasingly Require Robust Bioassays
Biologic drug development requires relevant bioassays to measure and help predict cellular response.
ADCs Reap the Benefits of Continual Research and Process Improvements
Deeper biological understanding and technology innovations have improved the fate of ADC development.
Improving the Fate of ADCs
Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.
Using Predictive Modeling to Optimize Bioreactor Performance
Using a predictive modeling approach can help tighten up operator control over bioprocessing, which in turn can increase bioreactor output.
Weighing the Benefits of Fermentation for New Biotherapies
The industry revisits the pros and cons of microbial fermentation at scale for biotherapeutics.
Considerations for Simplifying Downstream Processes
A simplified downstream process can save time and costs but requires enabling technologies.
Biotech Incubators Cultivate a Global Scene
The growth of the biopharmaceuticals market is feeding back into economies and, in part, is driving the boom in life sciences and biotech ecosystems.
Using a Drug Candidate Screening Strategy to Mitigate Late-Stage Risk
An early drug candidate screening strategy should incorporate clear targets to lessen late-stage failure.
Streamlining Bulk mAb Manufacturing
The projected growth in the biosimilars market will require increased bulk mAb manufacturing.
How Predictive Modeling Can Benefit Bioreactor Performance
A predictive modeling approach can offer tighter process control, which can optimize bioreactor output.
Animal Models Are Seeing Upgrades to Tackle Complex Molecule Testing
Preclinical testing is better able to evaluate complex drug candidates thanks to innovations in animal model approaches.
Driving Manufacturing Improvements Through Viral Vector Advances
The growth in demand of viral-vector-based gene therapies drives continuous efforts to improve viral vector manufacturing.
Development of Bispecific Antibodies Pushes Forward
The recent approvals of bispecific antibodies have opened the gate for the further development of these complex molecules.
Plant-based Expression Systems are Gaining Mainstream Advantage
Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.