Biologics APIs

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.

Resolving operational bottlenecks makes mAb manufacturing more efficient.

Spectrum Chemical has further expanded its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Personnel need to be trained in various analytical skill sets for biologic drug substance testing.

The collaboration between Bristol Myers Squibb and Century Therapeutics will combine Century’s iPSC-derived allogeneic cell therapy platform with Bristol Myers Squibb’s expertise in cell therapy and oncology drug development.

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

There is need for training personnel in various analytical skill sets for biologic drug substance testing.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

Secarna Pharmaceuticals and Achilles Therapeutics have entered into an agreement to optimize the development of T cell therapies in Achilles’ pipeline.

CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.

Under the expanded agreement with Agios, Centogene will provide global clinical trial support for thalassemia and sickle cell diseases.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.

NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.

Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.

Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.