API Synthesis and Manufacturing, Large Molecule

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Evonetix’s thermally controlled DNA synthesis technology is designed to enable highly parallel DNA synthesis in a benchtop platform.

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.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Agreements with the PolyPeptide Group and AGC Biologics will scale up production of the Novavax Matrix-M adjuvant.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Antibody-based drugs offer new mechanisms of action and greater specificity.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.