Analytical (technologies & services)

Cell therapy demand means CMOs need to up their capabilities, PharmSource

10-Apr-2018 By Dan Stanton

There is a lack of third-party capabilities in the autologous cell therapy space says the new editor of PharmSource ahead of this year’s Interphex Convention.

KBI, ReForm partnership about ‘bringing better biologics to patients,’ says CEO

05-Apr-2018 By Melissa Fassbender

KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.

“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.

Thermo Fisher mycoplasma detection tech accepted for cell therapies

04-Apr-2018 By Flora Southey

Thermo Fisher Scientific’s mycoplasma detection kit has been accepted by regulators for quality assurance, quality control and lot release.

MedImmune taps Israeli bi-specific antibody programme

04-Apr-2018 By Flora Southey

MedImmune will make bi-specific and multi-specific antibody products developed from Compugen’s pipeline under an exclusive license agreement.

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.

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.

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.

Draper touts new bioprocessing method as ‘next big advance in CAR T-cell treatment’

02-Mar-2018 By Melissa Fassbender

Draper has designed a microfluidic transduction device (MTD) it claims will help CAR T-cell therapy developers lower costs, up efficiency – and potentially bring manufacturing to the patient’s bedside.

Dyadic enters R&D deal for its fungus-based expression system

21-Feb-2018 By Dan Stanton

“There is a new kid on the block to rival E. Coli, CHO and yeast,” says Dyadic International as it collaborates to widen the use of its C1 expression tech.

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.

Q&A

AbSci hopes to make E. Coli great again through engineered expression system

07-Feb-2018 By Dan Stanton

AbSci says its genetically engineered E. coli expression platform has produced yields exceeding 20 g/L for difficult to express products and threatens the dominance of mammalian systems.

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.

Product characterisation key to successful CAR T therapies, Autolus

16-Jan-2018 By Dan Stanton

CAR T-cell understanding must come before the process design if such therapies are ever going to be accessible to a larger patient population, says Autolus.

Sartorius inks deal for Quad's T cell activation tech

12-Jan-2018 By Dan Stanton

Quad Technologies has teamed with Sartorius Stedim Biotech to expand the reach of its T-cell activation reagent for cell and gene therapy production.

Infliximab monograph adopted by European Pharmacopoeia Commission

10-Jan-2018 By Gareth Macdonald

European Pharmacopoeia Commission has adopted the first monograph for a monoclonal antibody and is poised to add it to the European Pharmacopoeia.

ADCs: Global service demand buoyed by approvals, WuXi

20-Dec-2017 By Dan Stanton

Antibody-drug conjugates (ADCs) are one of the “hottest areas of research” says STA Pharmaceutical and WuXi Biologics which are investing in conjugation and fill/finish capabilities in China.

Gilead buying Cell Design Labs for $567m in further CAR T boost

08-Dec-2017 By Staff Reporter

Months after jumping into the cell therapy space through the $11.9bn acquisition of Kite, Gilead has agreed to buy CAR T tech firm Cell Design Labs.

Cell Therapy Manufacturing & Gene Therapy Congress

Regulatory approvals and innovation drives: Cell therapies come of age

06-Dec-2017 By Dan Stanton

Cell therapies have reached their 'teenage years' and must now overcome processing efficiencies and quality struggles, say industry delegates.

US Biological inks antibody labelling deal with Sygnis subsidiary

05-Dec-2017 By Staff Reporter

Innova Biosciences says its Lightening-Link tech helps customers not to waste expensive reagents in antibody conjugation as it inks a supply deal with US Biological.

Vaccinex and Catalent team on cancer ADC development

05-Dec-2017 By Dan Stanton

The deal will see Vaccinex combine its antibody optimisation platform with Catalent’s conjugation and cell line engineering technologies.

Thermo Fisher suggests bio-researchers order before 2018 price hike:

29-Nov-2017 By Staff Reporter

Thermo Fisher will up its list prices by an average of 3.3% across much of its early-stage bioproduction product range, reflecting changing market conditions.

GE Healthcare buys nanofibre purification tech firm Puridify

28-Nov-2017 By Dan Stanton

GE says it will continue to invest in Puridify’s early-stage FibroSelect technology to bring it to full commercialisation.

ADC Bio: Industry unprepared for aggregation risk of next-generation ADCs

22-Nov-2017 By Dan Stanton

Antibody-drug conjugate (ADC) developers are at risk of aggregation issues caused by the hydrophobic nature of next-generation linker-payloads, says ADC Bio.

Avid letting Peregrine fly off as it focuses on bio-CDMO business

16-Nov-2017 By Dan Stanton

Peregrine Pharmaceuticals will become a pure-play CDMO under the name Avid Bioservices and is looking to sell or license its pipeline, including investigational monoclonal antibody bavituximab.

InVitria launches xeno-free formulation service within $5.2bn media market

10-Nov-2017 By InVitria launches xeno-free service within $5.2bn media market

Xeno-free media will continue to increase its share of the estimated 30m litre mammalian cell culture market says InVitria, which has launched a new formulation service.

UPDATE

Needle-free biologics: Takeda & Portal develop delivery tech for Crohn’s

09-Nov-2017 By Flora Southey

Takeda has partnered with Portal Instruments to develop a needle-free drug delivery device for biologic medicines, starting with the former’s Entyvio (vedolizumab).

Samsung BioLogics extends supply agreement with MilliporeSigma

08-Nov-2017 By Dan Stanton

Samsung BioLogics has extended a memorandum of understanding with MilliporeSigma for supply of single-use systems and bioprocessing raw materials.

Fujifilm adding three 2,000L GE single-use bioreactors as part of $30m expansion

06-Nov-2017 By Dan Stanton

Following a ‎¥14bn ($125m) investment in April, Fujifilm Corporation has committed a further ‎¥3.2bn across its biologics contract manufacturing business.

Infographic

Bioprocessing survey report: Is the CHO CHO train slowing down?

03-Nov-2017 By Dan Stanton

Nearly half the respondents of our second state of the global biomanufacturing survey believe we are too reliant on Chinese Hamster Ovary (CHO) expression systems.

Univercells: 'Micro-facilities' to slash the cost of vaccine manufacture

20-Oct-2017 By Cutting the cost of vaccine manufacture, Univercells

High-density single-use bioreactors, small facilities and continuous manufacturing will cut the cost of manufacturing polio vaccines down to $0.15 per dose, says Univercells.

Amgen: Industry must look to next-generation continuous cell harvesting tech

17-Oct-2017 By Dan Stanton

Amgen says it is evaluating Pall’s Cadence Acoustic Separation as a primary cell clarification method for monoclonal antibodies.

Batavia adding 50 jobs in US viral vector and EU cleanroom expansion

17-Oct-2017 By Dan Stanton

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

Selexis says KBI collaboration offers ‘gene to GMP’ in 10 months

13-Oct-2017 By Dan Stanton

Pelican Therapeutics has teamed with Selexis and sister CMO KBI Biopharma to advance two monoclonal antibody candidates.

News in Brief

MilliporeSigma opens $115m life science centre in Massachusetts

11-Oct-2017 By Staff Reporter

MilliporeSigma has cut the ribbon on a life science site in Burlington that incorporates a biomanufacturing equipment education centre.

Teva: CIP and SIP changes extended life of Protein A resin by 50%

11-Oct-2017 By Dan Stanton

Teva says it has increased the lifespan of its Protein A resin and thus reduced the cost of manufacturing monoclonal antibodies by tweaking its cleaning materials.

Cut price Kymriah? ThermoGenesis thinks so with automated CAR-T tech

10-Oct-2017 By Dan Stanton

ThermoGenesis says it can reduce the cost of making CAR-T cell therapies five-fold through its recently acquired automated tech platform.

Arecor licenses out formulation tech to biosimilar developer

10-Oct-2017 By Dan Stanton

Arecor says its protein and peptide formulation technology can provide a competitive advantage for biosimilar developers as it announces its first licensing deal.

Biotech Week Boston

Looking for RMAT designation? Ensure your clinical evidence is up to scratch

06-Oct-2017 By Dan Stanton

Clinical evidence is the most important part of any Regenerative Medicine Advanced Therapy (RMAT) application, according to a regulatory consultant.

Irvine Scientific expansion to offer dry powder media lots up to 7,000kg

28-Sep-2017 By Dan Stanton

Irvine Scientific has expanded its cell culture dry powder facility in California to support the projected increase of biotherapeutic production.

Biotech Week Boston

On the roadmap again: Industry to address 'never ending' bioprocessing evolution

27-Sep-2017 By Dan Stanton

The Biophorum Operations Group (BPOG) has begun working on 11 technology development projects after publishing its first roadmap, but the bioprocessing industry’s visions are forever evolving, says Sanofi-Genzyme.

ADC Biotechnology secures $11m for commercial biomanufacturing plant

26-Sep-2017 By Gareth Macdonald

ADC Biotechnology has announced it will spend $11m ($9.2m) build a bio-conjugation facility at a site in Deeside, North Wales.

Filling and freeze-drying drivers for $950m Cook deal says Catalent

22-Sep-2017 By Gareth Macdonald

Catalent has cited Cook’s ability to make and freeze-dry liquid drugs as major drivers for its planned takeover and said it is keen to take on the firm’s biopharma customers.