Bio-Outsourcing

“We need Big Pharma and we are getting Big Pharma,” says Dyadic

Dyadic confident Big Biopharma will move away from CHO cell reliance

04-Apr-2018 By Dan Stanton

Dyadic International says a string of deals shows biopharma is beginning to embrace its low-cost and high-yielding – yet commercially unproven – fungus-based expression platform.

Bioprocessing overlap: Taking lessons from small molecule makers

03-Apr-2018 By Dan Stanton

Process control, quality management and training operators are areas where biomanufacturers can learn from small molecule makers, according to preliminary results from a BioPlan Associates survey.

Continuous bioprocessing: A ‘life changing’ method, says NIBRT

30-Mar-2018 By Flora Southey

NIBRT is embracing continuous bioprocessing says training director John Milne, who told us the method helps improve plant flexibility and could reduce manufacturing costs.

Fujifilm pays $800m for cell culture media firm Irvine Scientific

30-Mar-2018 By Dan Stanton

Fujifilm has acquired Irvine Scientific, adding a range of cell culture media to its growing bioprocessing business.

PPD expands analytical lab to meet ‘growing’ demand for biologics testing

28-Mar-2018 By Melissa Fassbender

PPD has expanded its Middleton, WI-based GMP analytical laboratory, increasing its large molecule development capacity with space for more than 100 new employees.

News in Brief

Abzena remodels ADC facility in Pennsylvania

28-Mar-2018 By Staff Reporter

Abzena has equipped its $5m Pennsylvania bioconjugation suite with Sartoius and GE Healthcare single-use equipment.

Eye complaint: Novartis sues Regeneron for Lucentis manufacturing IP breach

28-Mar-2018 By Dan Stanton

Novartis says the manufacturing method for Regeneron’s wet macular degeneration drug Eylea (aflibercept) infringes on its Lucentis (ranibizumab) patents.

Back to school: Shire trains at NIBRT ahead of biologics site opening

28-Mar-2018 By Flora Southey

Shire is sending its employees to the National Institute for Bioprocessing and Research Training prior to opening its biomanufacturing site in Dunboyne, Ireland.

JV makes ‘stability timer’ logistics tech to protect cell and gene therapies

27-Mar-2018 By Flora Southey

The US Patent and Trademark Office has granted a notice of allowance for ‘shelf life’ timer technology used to protect time-sensitive biologic materials in transit.

Hitachi Chemical inks Daiichi Sankyo regenerative meds deal

27-Mar-2018 By Flora Southey

Daiichi Sankyo has selected CDMO Hitachi Chemical Therapeutics Solutions to make regenerative medicine for the Japanese market.

Tillots Pharma licenses CHO cell line tech from Lonza and BioWa

23-Mar-2018 By Staff Reporter

Lonza and BioWa’s POTELLIGENT CHOK1SV technology will be licensed by Tillots Pharma to develop its antibody pipeline.

Abzena strikes deal to access cell lines

23-Mar-2018 By Staff Reporter

Abzena has gained access to a major mammalian cell line depository it says will cut license negotiations for its customers.

Nohla signs WuXi AppTec to make cell therapies for bone marrow function

23-Mar-2018 By Flora Southey

Nohla Therapeutics has selected WuXi AppTec Advanced Therapies to make its lead candidate, indicated to treat patients with hematologic malignances.

WuXi Biologics adds 4,000L bioreactors at fully single-use site

21-Mar-2018 By Dan Stanton

The CMO says adding the single-use offering from ABEC will make the newly opened biomanufacturing site in China comparable to stainless steel for commercial mAb production.

CHO jumping: Samsung BioLogics to develop in-house cell line

20-Mar-2018 By Dan Stanton

Samsung BioLogics will begin offering its own CHO cell line for its customers’ development projects from 2019.

LenioBio teams with Dow for tobacco-based expression system

20-Mar-2018 By Dan Stanton

LenioBio will offer cell-free protein expression (CFPE) kits for drug screening through a partnership with DowDuPont, and says it is looking into using the tech for bioprocessing.

News in brief

ABL Europe equips viral vector plant with Sartorius single-use tech

16-Mar-2018 By Staff Reporter

Both upstream and downstream systems provided by Sartorius Stedim Biotech have been installed in ABL’s facility in Strasbourg, France.

BIOPHARMA AMBITION 2018

Flexible friend: Sanofi talks capacity benefits of Lonza JV

16-Mar-2018 By Flora Southey

Sharing a facility with a CMO gives Sanofi the flexibility to adjust biomanufacturing capacity according to its needs, says its SVP for biologics.

Compugen licenses Selexis cell line tech

15-Mar-2018 By Dan Stanton

Compugen has selected Selexis’ SUREtechnology cell expression platform to generate high-performance research cell banks (RCBs) and support its antibody pipeline.

Fujifilm to make AAVs for Regenxbio gene therapies

13-Mar-2018 By Staff Reporter

Regenxbio says a manufacturing contract with Fujifilm Diosynth Biotechnologies will support its gene therapy candidates.

NEWS IN BRIEF

WuXi BioLogics wins Adagene antibody therapeutics contract

13-Mar-2018 By Flora Southey

WuXi BioLogics will develop and manufacture Adagene’s antibody therapeutics for the Chinese market before expanding globally.

AGC Biologics adds 2,000L single-use bioreactor in CA

09-Mar-2018 By Dan Stanton

The biologics CDMO will install a 2,000L single-use bioreactor (SUB) from Thermo Fisher Scientific at its Berkeley facility to meet demand for early-phase projects.

Cryoport ups cold chain presence on regenerative med potential

07-Mar-2018 By Dan Stanton

Cryoport will open two global centres and has inked a deal with McKesson to support the growth in demand for cell and gene therapy logistics.

News in Brief

CDMO BioDuro acquires Molecular Response

05-Mar-2018 By Melissa Fassbender

BioDuro has acquired Molecular Response LLC and its translational oncology research platform, which includes a biobank of more than 100,000 viable tumor specimens.

Emerson gifts automation tech for simulated bioprocessing in Ireland

02-Mar-2018 By Flora Southey

Emerson is donating an automation platform worth $1m to Ireland’s NIBRT for ‘real-life’ industry training in Dublin.

CEL-SCI patent allows for LEAPS vaccine platform expansion

28-Feb-2018 By Staff Reporter

A newly approved patent will allow CEL-SCI to explore using cellular delivery to prevent and treat infectious diseases using its LEAPS technology, the firm says.

Samsung BioLogics wins potential $148m contract at new plant

23-Feb-2018 By Dan Stanton

The manufacturing contract is the first of what Samsung BioLogics expects to be a number of long-term partnerships at its recently completed 180,000L facility.

Perfusion to fed-batch: Repligen record quarter for ATF tech

23-Feb-2018 By Dan Stanton

Repligen says the single-use version of its alternating tangential flow (ATF) platform is helping the firm capture a larger share of the fed-batch bioreactor marketplace.

BIOPHARMA AMBITION 2018

From Dublin to Philadelphia: NIBRT expands to meet 'significant demand' for biomanufacturing talent

21-Feb-2018 By Flora Southey

NIBRT has announced plans to expand to North America next year in a partnership with Philadelphia’s Jefferson University.

Avid offloads Phase III mAb, becomes pureplay CDMO

20-Feb-2018 By Staff Reporter

Massachusetts-based Oncologie has agreed to buy Avid Bioservices’ bavituximab in a deal worth up to $103m.

Biologics demand drives Charles River lab ops transfer in Pennsylvania

20-Feb-2018 By Flora Southey

Charles River says increased demand for biologics services prompted its recent Devon Park facility acquisition, bringing its Pennsylvania site count to three

LakePharma ups biologics offering with Massachusetts site

16-Feb-2018 By Flora Southey

CDMO LakePharma has acquired a former-Stryker facility in Massachusetts to boost clinical biomanufacturing services.

Concurrent purification approach could cut ADC manufacture by 25%, ADC Bio

16-Feb-2018 By Dan Stanton

ADC Bio has developed a concurrent conjugation and antibody purification process, not reliant on Protein A capture resin.

Lonza rejigs network to tap 'huge potential' of cell and gene therapies

16-Feb-2018 By Dan Stanton

Lonza will combine its cell and gene therapy capabilities through four centres of excellence worldwide, following a number of investments in the space.

Correction

Repligen adding former Motorola plant in MA to filtration footprint

13-Feb-2018 By Dan Stanton

Repligen has leased a 64,000 square-foot facility in Massachusetts to where it will transfer production of its TangenX filtration products .

Horizon licenses ‘copy and paste’ tech to optimise commercial cell line

13-Feb-2018 By Flora Southey

Horizon’s gene editing technology will be used by a US immuno-oncology firm to make a cell line for commercial use.

Celltrion FDA warning causes headache for Teva’s biologics ambition

13-Feb-2018 By Dan Stanton

A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.

Denali signs Lonza to make biologics in first CMO deal

12-Feb-2018 By Flora Southey

Lonza has inked a biologics deal with Denali to make neurodegenerative disease therapies, offering the Californian firm opportunity to have production “on their back doorstep.”

UK collaboration to manufacture commercial viral vectors

09-Feb-2018 By Dan Stanton

Cobra Biologics and Symbiosis have received a grant to establish a commercial viral vector manufacturing facility in the UK.

Cook in the books: Biologics acquisition boosts Catalent Q2

09-Feb-2018 By Dan Stanton

Catalent has partially attributed a 26% year-on-year growth in its Drug Delivery Solutions segment to the acquisition of Cook Pharmica, which closed in the quarter.

Cryoport wins TiGenix logistics contract and braces for CAR T roll out

09-Feb-2018 By Staff Reporter

Cryoport will provide cold chain logistics to TiGenix as it conducts phase Ib/IIa allogeneic adipose‐derived stem cells for the treatment of sepsis.

Making an HIV cure: AGT completes process development for T-cell therapy

06-Feb-2018 By Dan Stanton

American Gene Technologies International (AGT) says its HIV candidate is ‘the most complex cell therapy the industry has delivered to date.’

Waters launches LC platform-neutral bioseparations system

06-Feb-2018 By Staff Reporter

Waters Corporation says its latest bioseparations system can drive cost-savings through reduced solvent volumes and decreased run times.

Adaptimmune begins in-house T-cell therapy manufacture at PA plant

06-Feb-2018 By Staff Reporter

Adaptimmune Therapeutics has manufactured the first SPEAR-T cells for a patient at its Navy Yard facility, which will be the primary site for its future manufacturing requirements.

Pall the ‘stand-out’ in Danaher’s life sciences Q4 results

31-Jan-2018 By Staff Reporter

Pall Corporation reported its best quarterly growth since its acquisition by Danaher in 2015.

GigaGen’s Cali lab upgrade for antibody discovery

31-Jan-2018 By Flora Southey

GigaGen has relocated laboratory and office space in San Francisco to boost development of antibody therapeutics for patients with immune dysregulation.

UCL to harness Synpromics' promotors in gene therapy collaboration

30-Jan-2018 By Flora Southey

Synpromics will make synthetic promotors for a collaboration with UCL Great Ormond Street Institute of Child Health to develop gene therapies for blood-based disorders.

Bigger in Texas: Fujifilm adds 6,000L and opens gene therapy plant

30-Jan-2018 By Dan Stanton

The need for CDMOs with commercial gene therapy capacity is growing says Fujilfilm Diosynth Biotechnologies, which has opened an 80,000 square-foot plant in Texas.