Global Markets

Avid: Balancing MAb capacity with industry’s growing needs

Monoclonal antibody (MAb) capacity remains roughly in balance with industry’s needs but firms should look to procure manufacturing services early to guarantee their projects, says CDMO Avid Bioservices. Twelve months ago, Peregrine Pharmaceuticals sold its internal monoclonal antibody (MAb) programs and became a pure contract development and manufacturing organization (CDMO) under the Avid Bioservices title. The CDMO has GMP facilities in Orange County, California offering biopharma firms both stainless steel and single-use biologics manufacturing services. As such, the firm spoke to…

Biotech patents: How to protect from IP threats

Thomas Wolski, partner at The Webb Law Firm, says biotech firms must file more patent applications earlier to overcome the threats of US legal uncertainty and unclear guidance. Uncertainty in US laws is one of the threats that the biotech industry has and continues to face when it comes to patents. And it seems like every patent case that the Supreme Court takes these days has a strong chance of reversing the Federal Circuit’s decision. To compound the problem, Congress’s…

Business must harness tech and innovation to thrive, says new Locate Bio CEO

Biotech must work at the frontiers of biology and innovation while operating in a highly regulated environment says business development expert Nick Staples, the new CEO of Locate Bio. UK-based cell and gene therapy firm Locate Bio has had a reshuffle at the top, hiring veteran biopharma business executive and industry analyst Dr Nick Staples as CEO. BioProcess Insider spoke with Staples to find out his vision for Locate Bio, and how best to manage the often conflicting business and…

Novartis teams with Chinese drugmaker to enter insulin biosimilars space

Novartis division Sandoz has partnered with Chinese manufacturer Gan & Lee to bring biosimilar insulins to the US and EU. The agreement will see China’s Gan & Lee supply Sandoz with insulin glargine, lispro and aspart products for use in patients with type 1 and type 2 diabetes for commercialization in Europe and the US, along with other key markets. “After conducting a significant review, Sandoz decided to collaborate with Gan & Lee, the third largest insulin distributor headquartered in…

Global biologics demand driving MabPlex expansions

MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

Korea exchange: Celltrion probed as Samsung Bio resumes trading

An investigating has begun into alleged accounting irregularities between Celltrion Inc. and its affiliate Celltrion Healthcare. Meanwhile, Samsung BioLogics has recommenced share trading a month after being hit by its own accountancy problems. South Korea’s Financial Supervisory Services (FSS) is looking into the business dealings of drugmaker Celltrion Inc and its wholesaler and marketing affiliate Celltrion Healthcare, according to Korean news outlet YTN. The article claimed Celltrion Healthcare violated accounting rules by selling the domestic distribution rights of biological medicines…

Manufacturing shutdowns and idle capacity mar Avid’s Q2

Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…

Lonza to biomanufacture in China with a little help from GE

Changing policies in China bring opportunities for foreign CDMOs says Lonza, which is opening a biologics facility in Guangzhou, supported by GE Healthcare. Swiss contract development and manufacturing organization(CDMO) Lonza has announced it is constructing its first biomanufacturing facility in China. The 17,000 m² plant will be based on GE Healthcare’s off-the-shelf modular biologics factory, KUBio platform, and will supply antibody drugs to the local market. “We do have an established presence in China and in theGuangzhou district but this…

French staff cuts but Sanofi committed to $800m biomanufacturing plans

Sanofi will cut 750 jobs in France but says it remains committed to biologic and vaccine manufacturing investments totaling €700 million ($800 million) in the country. With civil unrest breaking out on the streets of Paris as members of the so-called ‘Gilets Jaunes’ demand everything from lower taxes to better job security, France’s largest biopharma firm Sanofi has revealed plans to reduce its domestic workforce by 750, and scrap plans to recruit a further 250 staff. “Sanofi in France informed…